xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06040944</url>
    </required_header>
    <id_info>
      <org_study_id>19038219038211011</org_study_id>
      <nct_id>NCT06040944</nct_id>
    </id_info>
    <brief_title>Antipsychotic Induced Hyperprolactinemaia as Risk Factor for Periodontitis in Schizophrenic Patients</brief_title>
    <official_title>The Effect of Antipsychotic Medication and the Associated Hyperprolactinemia as Risk Factor for Periodontal Diseases in Schizophrenic Patients: a Cohort Retrospective Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fayoum University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fayoum University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of the present cohort retrospective study is to explore the effect of antipsychotics&#xD;
        on periodontal health and the possible effect of antipsychotic-induced hyperprolactinemia as&#xD;
        a risk factor for periodontal disease progression in schizophrenic patients.&#xD;
  &#xD;
        The study population consisted of three groups: Group A (n = 21): schizophrenic patients who&#xD;
        have been taking &quot;prolactin inducing&quot; antipsychotics for at least 1 year, Group B (n = 21):&#xD;
        schizophrenic patients who have been taking &quot;prolactin sparing&quot; antipsychotics for at least 1&#xD;
        year and Group C (n = 22): newly diagnosed schizophrenic patients and/or patients who did not&#xD;
        receive any psychiatric treatment for at least 1 year.&#xD;
  &#xD;
        The study groups underwent an assessment of periodontal condition in terms of pocket depth&#xD;
        (PD), clinical attachment loss (CAL), gingival recession, tooth mobility, and bleeding on&#xD;
        probing (BOP). Also, bone mineral density was evaluated using DEXA scans and the serum&#xD;
        prolactin level was measured by automated immunoassay.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Background and objective: The aim of the present cohort retrospective study is to explore the&#xD;
        effect of antipsychotics on periodontal health and the possible effect of&#xD;
        antipsychotic-induced hyperprolactinemia as a risk factor for periodontal disease progression&#xD;
        in schizophrenic patients.&#xD;
  &#xD;
        Methods&#xD;
  &#xD;
          1. Study design and setting:&#xD;
  &#xD;
             The current study is a cohort retrospective study that will be performed on&#xD;
             schizophrenic patients. All subjects will be recruited from the outpatient clinic of the&#xD;
             department of Psychiatry-Faculty of Medicine- MUST University. The patients' database&#xD;
             from the department of psychiatry will be filtered, and all patients with a diagnosis of&#xD;
             schizophrenia according to DSM-IV-TR criteria for schizophrenia and fulfilling&#xD;
             eligibility criteria will be contacted. Also, outpatients newly diagnosed with&#xD;
             schizophrenia will be included. Those who agree to be enrolled in the study will sign a&#xD;
             written informed consent. For patients previously diagnosed with schizophrenia,&#xD;
             medication data will be acquired from prescription files, including the type and&#xD;
             duration of the prescribed antipsychotic or other medications.&#xD;
  &#xD;
             Psychiatric assessment and recording of demographic variables such as age, gender,&#xD;
             duration of psychiatric disease, and type and duration of antipsychotic medication will&#xD;
             be performed by the second investigator (EM.A). Then, all subjects will be referred,&#xD;
             with their records and files, to the Faculty of Dentistry at ACU University for&#xD;
             periodontal assessment and sample collection.&#xD;
  &#xD;
          2. Eligibility criteria:&#xD;
  &#xD;
             The included patients are those: 1) with the diagnosis of schizophrenia; 2) over 20&#xD;
             years old; 3) who did not receive any periodontal treatment for the past year; and 4)&#xD;
             with at least 20 remaining teeth. To avoid potential confounding factors, the excluded&#xD;
             patients are: 1) those with systemic conditions that may affect periodontal status such&#xD;
             as; DM, CVS, metabolic syndrome, osteoporosis, AIDS, and chronic alcoholism (3, 4, 17);&#xD;
             2) those with local factors that may aggravate and predispose for periodontal diseases,&#xD;
             such as orthodontic and prosthetic appliances, parafunctional habits, and heavy smoking&#xD;
             (4, 23-25); and 3) those receiving any systemic medication and/or systemic antibiotics&#xD;
             for the past 6 months. Additionally, exclusion criteria involved 4) patients undergoing&#xD;
             any type of periodontal treatment for the past year; 5) patients within the childhood&#xD;
             and adolescent psychiatry section; and 6) patients who received antipsychotic medication&#xD;
             for ≥ 12 months.&#xD;
  &#xD;
          3. Estimating the sample size:&#xD;
  &#xD;
             The sample size was calculated considering type I error (α) of 0.05 and power (1-β) of&#xD;
             0.9. Based on a previous study by (16) that used proportions, inequality, and two&#xD;
             independent groups (Fisher's exact test) to compare patients with a pocket depth of 4 mm&#xD;
             to those with no pocket depth identified in patients receiving antipsychotics 12 months&#xD;
             with effect size, the sample size was calculated and found to be a total of 64 patients.&#xD;
             The application G*Power 3.1.9.7 [16] was used to determine the sample size needed for&#xD;
             the study.&#xD;
  &#xD;
          4. Participants:&#xD;
  &#xD;
        The study population will be divided into three groups: Exposure groups will be divided&#xD;
        according to their &quot;prolactin-inducing&quot; or &quot;prolactin sparing&quot; effect (26-36). Group A (n =&#xD;
        21): schizophrenic patients that have been taking antipsychotic medication that may induce&#xD;
        hyperprolactinemia (FGAs and SGAs; amisulpride, risperidone, and paliperidone) for at least 1&#xD;
        year, group B (n = 21): schizophrenic patients who have been taking antipsychotics that do&#xD;
        not have a significant effect on serum prolactin levels (in SGAs, clozapine, quetiapine,&#xD;
        olanzapine, ziprasidone, and aripiprazole) for at least 1 year and Group C (n = 22): newly&#xD;
        diagnosed schizophrenic patients and/or patients who did not receive any psychiatric&#xD;
        treatment for at least 1 year.&#xD;
  &#xD;
        [4] Outcome measurements: The primary outcome was the assessment of periodontal condition in&#xD;
        all study groups measured in terms of pocket depth (PD), tooth mobility, clinical attachment&#xD;
        loss (CAL), gingival recession, and bleeding on probing (BOP), while the secondary outcomes&#xD;
        were evaluation of BMD and the serum prolactin level (measured by automated immunoassay in&#xD;
        ng/ml).&#xD;
  &#xD;
        [6]Assessment of clinical data and patient condition: Assessment of mental health: The&#xD;
        Positive and Negative Syndrome Scale (PNSS) (37) was used to evaluate each patient's clinical&#xD;
        history and current mental health state.&#xD;
  &#xD;
        Periodontal evaluation:&#xD;
  &#xD;
        All teeth were evaluated and recorded. The means for the following parameters were computed:&#xD;
        pocket depth (PD), clinical attachment loss (CAL), and bleeding on probing (BOP) (38, 39).&#xD;
        Using a manual periodontal probe (Williams' periodontal probe, PCP-12; Hu-Friedy, Chicago,&#xD;
        IL, USA), PD and CAL measurements were collected on six surfaces per tooth (mesio-buccal,&#xD;
        mid-buccal, disto-buccal, and mesio-lingual, mid-lingual, disto-lingual, or palatal&#xD;
        surface).While CAL measures the distance between the cement-enamel junction of the tooth and&#xD;
        the deepest aspect of the pocket, probing pocket depth measures the distance between the&#xD;
        gingival margin and the deepest part of the pocket. Total mean PD of the six locations for&#xD;
        each tooth was computed for each patient and distance was recorded to the nearest millimeter&#xD;
        (40). Sulcus depths between 0 and 2 mm were regarded as normal (41). Gingival recession was&#xD;
        measured from the CEJ to the marginal border of the soft tissue on the buccal and lingual&#xD;
        sides of each tooth. The total mean number of recessions per tooth for each patient was used&#xD;
        to record tooth recessions. Gingival recession, if present, was only used to calculate CAL by&#xD;
        its addition to PD.&#xD;
  &#xD;
        Four surfaces per tooth were examined for BOP readings (mesial, distal, buccal, and lingual&#xD;
        or palatal surface). Bleeding on probing was examined directly after the PD measurement and&#xD;
        was reported as absent (0) or present (1). 30 seconds after applying the periodontal probe).&#xD;
        The proportion of teeth displaying BOP was recorded.&#xD;
  &#xD;
        Generalized mild periodontitis is defined as &gt;30% of remaining teeth with PD 5 mm and 7 mm,&#xD;
        as per the 2015 Update to the 1999 Classification of Periodontitis. Severe periodontitis was&#xD;
        defined as a probing depth (PD) of 7 mm, with localised periodontitis involving 30% of&#xD;
        remaining teeth and generalised periodontitis involving &gt;30% of remaining teeth (42) .&#xD;
  &#xD;
        Assessment of bone mineral density:&#xD;
  &#xD;
        Dual-energy X-ray absorptiometry (DEXA scan) is an advanced technology that could detect bone&#xD;
        mineral density. The GE Lunar Prodigy densitometer was used to perform this test.To determine&#xD;
        what constitutes healthy bone, we utilized the World Health Organization's criteria: a T&#xD;
        score of -1 indicates normal bone, a T score between -1 and -2.5 indicates osteopaenia, and a&#xD;
        T score of -2.5 indicates osteoporosis.&#xD;
  &#xD;
        Measurement of serum prolactin level:&#xD;
  &#xD;
        Blood will be withdrawn from all patients to determine the fasting serum prolactin level.&#xD;
        Prolactin concentrations in blood will be measured in a faculty laboratory by automated&#xD;
        immunoassay methodology (43).&#xD;
  &#xD;
        7] Data collection and management: Periodontal assessment will be carried out by the primary&#xD;
        investigator (S.R.), who will be unaware of the patient's psychological status and records&#xD;
        (to avoid potential bias). The third investigator (M.C.) will collect all patient records to&#xD;
        perform the final analysis.&#xD;
  &#xD;
        STATISTICAL METHODS:&#xD;
  &#xD;
        Quantitative (continuous) variables were expressed as mean ± SD. As the quantitative&#xD;
        variables were not normally distributed, the Kruskal-Wallis test (a non-parametric test) was&#xD;
        used to compare them among the 3 study groups. A post hoc analysis was done for variables&#xD;
        that showed a statistically significant difference in the Kruskal-Wallis test using&#xD;
        Dwass-Steel-Critchlow-Fligner pairwise comparisons. As for qualitative variables&#xD;
        (categorical), the chi-square test was used to compare them among the 3 study groups, and&#xD;
        values were expressed as percentages. Also, linear regression analysis was performed to study&#xD;
        the relation between 2 quantitative variables (serum prolactin level and PD measurements),&#xD;
        while ordinal logistic regression was used to relate one quantitative (serum prolactin level)&#xD;
        and one qualitative (BMD or grades of periodontitis) variables.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">September 1, 2022</start_date>
    <completion_date type="Actual">November 1, 2022</completion_date>
    <primary_completion_date type="Actual">October 1, 2022</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Severity of periodontal diseases</measure>
      <time_frame>1 months</time_frame>
      <description>The primary outcome will be the assessment of periodontal condition in all study groups measured in terms of Pocket depth (PD), clinical attachment loss (CAL) (both measured using graduated periodontal probe in mm)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>gingival condition</measure>
      <time_frame>1 months</time_frame>
      <description>bleeding on probing (BOP) using scores from 0-3</description>
    </primary_outcome>
    <primary_outcome>
      <measure>tooth mobility</measure>
      <time_frame>1 months</time_frame>
      <description>in mm</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Serum prolactin level</measure>
      <time_frame>1 months</time_frame>
      <description>measurement of serum prolactin level ( measured by automated immunoassay in ng/ml)</description>
    </secondary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Actual">64</enrollment>
    <condition>Schizophrenia Spectrum and Other Psychotic Disorders</condition>
    <condition>Periodontal Diseases</condition>
    <arm_group>
      <arm_group_label>Exposure 1</arm_group_label>
      <description>Schizophrenic patients that have been taking antipsychotic drugs inducing hyperprolactinemia (FGAs and the SGAs; amisulpride, risperidone and paliperidone) for at least 1 year</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Exposure 2</arm_group_label>
      <description>Schizophrenic patients that have been taking antipsychotics sparing hyperprolactinemia (In SGAs; clozapine, quetiapine, olanzapine, ziprasidone and aripiprazole) for at least 1 year</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Non exposure (basline)</arm_group_label>
      <description>Newly diagnosed schizophrenic patients and/ or patients did not receive any psychiatric treatment for at least 1 year</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>antipsychotic drugs inducing hyperprolactinemia</intervention_name>
      <description>not exposed</description>
      <arm_group_label>Exposure 1</arm_group_label>
      <other_name>antipsychotic drugs not inducing hyperprolactinemia</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          diagnosis of schizophrenia according to DSM-IV-TR criteria for schizophrenia&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. with the diagnosis of schizophrenia&#xD;
  &#xD;
            2. over 20 years old&#xD;
  &#xD;
            3. did not receive any periodontal treatment for the past year&#xD;
  &#xD;
            4. with at least 20 remaining teeth.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. with systemic condition that may affect periodontal status such as; DM, cardiovascular&#xD;
               diseases, metabolic syndrome, osteoporosis, AIDS and chronic alcoholism&#xD;
  &#xD;
            2. having local factors that may aggravate and predispose for periodontal diseases such&#xD;
               as; orthodontic and prosthetic appliances, parafunctional habits, and heavy smoking&#xD;
  &#xD;
            3. receiving any systemic medication and/or systemic antibiotics for the past 6 months.&#xD;
  &#xD;
            4. patients undergoing any type of periodontal treatment for the past year and&#xD;
  &#xD;
            5. within childhood and adolescence psychiatry section.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Rania H Shalby, phd</last_name>
      <role>Principal Investigator</role>
      <affiliation>Faculty of Dentistry-Fayoum University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Rania Hassan Shalby</name>
        <address>
          <city>Giza</city>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>March 10, 2023</study_first_submitted>
    <study_first_submitted_qc>September 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 10, 2023</last_update_submitted>
    <last_update_submitted_qc>September 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Fayoum University</investigator_affiliation>
      <investigator_full_name>Rania Hassan Shalby</investigator_full_name>
      <investigator_title>Lecturer of Oral Medicine</investigator_title>
    </responsible_party>
    <keyword>schizophrenia</keyword>
    <keyword>antipsychotics</keyword>
    <keyword>periodontal disease</keyword>
    <keyword>hyperprolactinemia</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Periodontal Diseases</mesh_term>
      <mesh_term>Hyperprolactinemia</mesh_term>
      <mesh_term>Schizophrenia</mesh_term>
      <mesh_term>Psychotic Disorders</mesh_term>
      <mesh_term>Schizophrenia Spectrum and Other Psychotic Disorders</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Antipsychotic Agents</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06040944
  org study id: 19038219038211011
  nct id: NCT06040944
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  The aim of the present cohort retrospective study is to explore the effect of antipsychotics
        on periodontal health and the possible effect of antipsychotic-induced hyperprolactinemia as
        a risk factor for periodontal disease progression in schizophrenic patients.
  
        The study population consisted of three groups: Group A (n = 21): schizophrenic patients who
        have been taking "prolactin inducing" antipsychotics for at least 1 year, Group B (n = 21):
        schizophrenic patients who have been taking "prolactin sparing" antipsychotics for at least 1
        year and Group C (n = 22): newly diagnosed schizophrenic patients and/or patients who did not
        receive any psychiatric treatment for at least 1 year.
  
        The study groups underwent an assessment of periodontal condition in terms of pocket depth
        (PD), clinical attachment loss (CAL), gingival recession, tooth mobility, and bleeding on
        probing (BOP). Also, bone mineral density was evaluated using DEXA scans and the serum
        prolactin level was measured by automated immunoassay.
  Background and objective: The aim of the present cohort retrospective study is to explore the
        effect of antipsychotics on periodontal health and the possible effect of
        antipsychotic-induced hyperprolactinemia as a risk factor for periodontal disease progression
        in schizophrenic patients.
  
        Methods
  
          1. Study design and setting:
  
             The current study is a cohort retrospective study that will be performed on
             schizophrenic patients. All subjects will be recruited from the outpatient clinic of the
             department of Psychiatry-Faculty of Medicine- MUST University. The patients' database
             from the department of psychiatry will be filtered, and all patients with a diagnosis of
             schizophrenia according to DSM-IV-TR criteria for schizophrenia and fulfilling
             eligibility criteria will be contacted. Also, outpatients newly diagnosed with
             schizophrenia will be included. Those who agree to be enrolled in the study will sign a
             written informed consent. For patients previously diagnosed with schizophrenia,
             medication data will be acquired from prescription files, including the type and
             duration of the prescribed antipsychotic or other medications.
  
             Psychiatric assessment and recording of demographic variables such as age, gender,
             duration of psychiatric disease, and type and duration of antipsychotic medication will
             be performed by the second investigator (EM.A). Then, all subjects will be referred,
             with their records and files, to the Faculty of Dentistry at ACU University for
             periodontal assessment and sample collection.
  
          2. Eligibility criteria:
  
             The included patients are those: 1) with the diagnosis of schizophrenia; 2) over 20
             years old; 3) who did not receive any periodontal treatment for the past year; and 4)
             with at least 20 remaining teeth. To avoid potential confounding factors, the excluded
             patients are: 1) those with systemic conditions that may affect periodontal status such
             as; DM, CVS, metabolic syndrome, osteoporosis, AIDS, and chronic alcoholism (3, 4, 17);
             2) those with local factors that may aggravate and predispose for periodontal diseases,
             such as orthodontic and prosthetic appliances, parafunctional habits, and heavy smoking
             (4, 23-25); and 3) those receiving any systemic medication and/or systemic antibiotics
             for the past 6 months. Additionally, exclusion criteria involved 4) patients undergoing
             any type of periodontal treatment for the past year; 5) patients within the childhood
             and adolescent psychiatry section; and 6) patients who received antipsychotic medication
             for ≥ 12 months.
  
          3. Estimating the sample size:
  
             The sample size was calculated considering type I error (α) of 0.05 and power (1-β) of
             0.9. Based on a previous study by (16) that used proportions, inequality, and two
             independent groups (Fisher's exact test) to compare patients with a pocket depth of 4 mm
             to those with no pocket depth identified in patients receiving antipsychotics 12 months
             with effect size, the sample size was calculated and found to be a total of 64 patients.
             The application G*Power 3.1.9.7 [16] was used to determine the sample size needed for
             the study.
  
          4. Participants:
  
        The study population will be divided into three groups: Exposure groups will be divided
        according to their "prolactin-inducing" or "prolactin sparing" effect (26-36). Group A (n =
        21): schizophrenic patients that have been taking antipsychotic medication that may induce
        hyperprolactinemia (FGAs and SGAs; amisulpride, risperidone, and paliperidone) for at least 1
        year, group B (n = 21): schizophrenic patients who have been taking antipsychotics that do
        not have a significant effect on serum prolactin levels (in SGAs, clozapine, quetiapine,
        olanzapine, ziprasidone, and aripiprazole) for at least 1 year and Group C (n = 22): newly
        diagnosed schizophrenic patients and/or patients who did not receive any psychiatric
        treatment for at least 1 year.
  
        [4] Outcome measurements: The primary outcome was the assessment of periodontal condition in
        all study groups measured in terms of pocket depth (PD), tooth mobility, clinical attachment
        loss (CAL), gingival recession, and bleeding on probing (BOP), while the secondary outcomes
        were evaluation of BMD and the serum prolactin level (measured by automated immunoassay in
        ng/ml).
  
        [6]Assessment of clinical data and patient condition: Assessment of mental health: The
        Positive and Negative Syndrome Scale (PNSS) (37) was used to evaluate each patient's clinical
        history and current mental health state.
  
        Periodontal evaluation:
  
        All teeth were evaluated and recorded. The means for the following parameters were computed:
        pocket depth (PD), clinical attachment loss (CAL), and bleeding on probing (BOP) (38, 39).
        Using a manual periodontal probe (Williams' periodontal probe, PCP-12; Hu-Friedy, Chicago,
        IL, USA), PD and CAL measurements were collected on six surfaces per tooth (mesio-buccal,
        mid-buccal, disto-buccal, and mesio-lingual, mid-lingual, disto-lingual, or palatal
        surface).While CAL measures the distance between the cement-enamel junction of the tooth and
        the deepest aspect of the pocket, probing pocket depth measures the distance between the
        gingival margin and the deepest part of the pocket. Total mean PD of the six locations for
        each tooth was computed for each patient and distance was recorded to the nearest millimeter
        (40). Sulcus depths between 0 and 2 mm were regarded as normal (41). Gingival recession was
        measured from the CEJ to the marginal border of the soft tissue on the buccal and lingual
        sides of each tooth. The total mean number of recessions per tooth for each patient was used
        to record tooth recessions. Gingival recession, if present, was only used to calculate CAL by
        its addition to PD.
  
        Four surfaces per tooth were examined for BOP readings (mesial, distal, buccal, and lingual
        or palatal surface). Bleeding on probing was examined directly after the PD measurement and
        was reported as absent (0) or present (1). 30 seconds after applying the periodontal probe).
        The proportion of teeth displaying BOP was recorded.
  
        Generalized mild periodontitis is defined as >30% of remaining teeth with PD 5 mm and 7 mm,
        as per the 2015 Update to the 1999 Classification of Periodontitis. Severe periodontitis was
        defined as a probing depth (PD) of 7 mm, with localised periodontitis involving 30% of
        remaining teeth and generalised periodontitis involving >30% of remaining teeth (42) .
  
        Assessment of bone mineral density:
  
        Dual-energy X-ray absorptiometry (DEXA scan) is an advanced technology that could detect bone
        mineral density. The GE Lunar Prodigy densitometer was used to perform this test.To determine
        what constitutes healthy bone, we utilized the World Health Organization's criteria: a T
        score of -1 indicates normal bone, a T score between -1 and -2.5 indicates osteopaenia, and a
        T score of -2.5 indicates osteoporosis.
  
        Measurement of serum prolactin level:
  
        Blood will be withdrawn from all patients to determine the fasting serum prolactin level.
        Prolactin concentrations in blood will be measured in a faculty laboratory by automated
        immunoassay methodology (43).
  
        7] Data collection and management: Periodontal assessment will be carried out by the primary
        investigator (S.R.), who will be unaware of the patient's psychological status and records
        (to avoid potential bias). The third investigator (M.C.) will collect all patient records to
        perform the final analysis.
  
        STATISTICAL METHODS:
  
        Quantitative (continuous) variables were expressed as mean ± SD. As the quantitative
        variables were not normally distributed, the Kruskal-Wallis test (a non-parametric test) was
        used to compare them among the 3 study groups. A post hoc analysis was done for variables
        that showed a statistically significant difference in the Kruskal-Wallis test using
        Dwass-Steel-Critchlow-Fligner pairwise comparisons. As for qualitative variables
        (categorical), the chi-square test was used to compare them among the 3 study groups, and
        values were expressed as percentages. Also, linear regression analysis was performed to study
        the relation between 2 quantitative variables (serum prolactin level and PD measurements),
        while ordinal logistic regression was used to relate one quantitative (serum prolactin level)
        and one qualitative (BMD or grades of periodontitis) variables.
  observational model: Cohort
  time perspective: Retrospective
  measure: Severity of periodontal diseases
  time frame: 1 months
  description: The primary outcome will be the assessment of periodontal condition in all study groups measured in terms of Pocket depth (PD), clinical attachment loss (CAL) (both measured using graduated periodontal probe in mm)
  measure: gingival condition
  time frame: 1 months
  description: bleeding on probing (BOP) using scores from 0-3
  measure: tooth mobility
  time frame: 1 months
  description: in mm
  measure: Serum prolactin level
  time frame: 1 months
  description: measurement of serum prolactin level ( measured by automated immunoassay in ng/ml)
  arm group label: Exposure 1
  description: Schizophrenic patients that have been taking antipsychotic drugs inducing hyperprolactinemia (FGAs and the SGAs; amisulpride, risperidone and paliperidone) for at least 1 year
  arm group label: Exposure 2
  description: Schizophrenic patients that have been taking antipsychotics sparing hyperprolactinemia (In SGAs; clozapine, quetiapine, olanzapine, ziprasidone and aripiprazole) for at least 1 year
  arm group label: Non exposure (basline)
  description: Newly diagnosed schizophrenic patients and/ or patients did not receive any psychiatric treatment for at least 1 year
  intervention type: Drug
  intervention name: antipsychotic drugs inducing hyperprolactinemia
  description: not exposed
  arm group label: Exposure 1
  other name: antipsychotic drugs not inducing hyperprolactinemia
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: N/A
  last name: Rania H Shalby, phd
  role: Principal Investigator
  affiliation: Faculty of Dentistry-Fayoum University
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Fayoum University
  investigator full name: Rania Hassan Shalby
  investigator title: Lecturer of Oral Medicine
  mesh term: Periodontal Diseases
  mesh term: Hyperprolactinemia
  mesh term: Schizophrenia
  mesh term: Psychotic Disorders
  mesh term: Schizophrenia Spectrum and Other Psychotic Disorders
  mesh term: Antipsychotic Agents
  sharing ipd: No