<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/NCT03003052</url>
  </required_header>
  <id_info>
    <org_study_id>TCC-RD-01</org_study_id>
    <nct_id>NCT03003052</nct_id>
  </id_info>
  <brief_title>Assessing Current Clinical Concepts in Dental Practice</brief_title>
  <official_title>Assessing Current Clinical Concepts in Dental Practice</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Campbell Clinic, UK</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Campbell Clinic, UK</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This purpose of this database is to collect, store and use appropriately derived data from&#xD;
      routine patient care in a specialist dental practice. Comprehensive observational data will&#xD;
      be gathered, systematically organised and be continuously updated. This data will be used to&#xD;
      evaluate treatment outcomes and identify areas for improvement. This will contribute to the&#xD;
      existing evidence base to validate new and current clinical concepts in dentistry. Patient&#xD;
      consent will be sought for this, and all data extracted from patient notes will be stored and&#xD;
      used anonymously. Use of the Oral Health Impact Profile (OHIP) -14 questionnaire pre and post&#xD;
      treatment will be used to assess patient satisfaction with outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Specialist dentistry uses a combination of techniques resulting from joint decisions between&#xD;
      clinicians and patients, aimed at giving the patient what is perceived to be the best&#xD;
      possible outcome. However, as new techniques and approaches develop, there is capacity for&#xD;
      more evidence to justify one treatment option over another, both clinically and most&#xD;
      importantly, from the patient perspective.&#xD;
&#xD;
      The aim of this project is to set up a research database which will enable the collection and&#xD;
      storage of appropriately derived data from routine patient care and from patient&#xD;
      questionnaires (using OHIP-14). This data will be used in cohort studies/case series&#xD;
      reports/comparative studies with other practices.&#xD;
&#xD;
      It is believed that this process will provide an effective way of evidencing predictable&#xD;
      outcomes, assist in the development of improved clinical techniques, provide additional&#xD;
      guidance and support for patients, and further clinical research in dental practice. In&#xD;
      addition, implementation of studies to track patient satisfaction with clinical outcomes will&#xD;
      provide advanced support in the decision making process.&#xD;
&#xD;
      All adult patients treated at The Campbell Clinic will be approached for consent. This will&#xD;
      be an ongoing process, to maximize sample size. Treatment decisions will be continue to be&#xD;
      made jointly by clinician and patient and will not be altered by participation in this study.&#xD;
      Patient consent will be sought, and all data will be anonymised for storage in the database.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">July 2026</completion_date>
  <primary_completion_date type="Anticipated">July 2026</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>4 Years</target_duration>
  <primary_outcome>
    <measure>Implant Success - clinical measures</measure>
    <time_frame>up to 4 years</time_frame>
    <description>Assessment of implant success (signs of implant mucositis peri-implantitis), functionality and aesthetic results. Categorised/grouped by surgery type: single/multiple implant, use of sinus lift, and other variables.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Implant Success - patient defined</measure>
    <time_frame>up to 4 years</time_frame>
    <description>Assessment of functionality and aesthetic results from patient perspective - measured using OHIP-14 patient questionnaire.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Dental Implant</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Dental implants</intervention_name>
    <description>Data collection from pre-implant assessment, implant surgery, and hygiene recall appointments, to assess implant survival and success.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All adult patients treated at the Campbell Clinic, with focus on dental implants&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. be a patient at The Campbell Clinic&#xD;
&#xD;
          2. be planning to undergo or have undergone specialist dental treatment, usually involved&#xD;
             dental implants&#xD;
&#xD;
          3. be able to read and understand Patient Information Sheet&#xD;
&#xD;
          4. Have signed informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. concern that patient has not understood patient information sheet (e.g. due to&#xD;
             language /interpretation issues)&#xD;
&#xD;
          2. not willing to sign consent form&#xD;
&#xD;
          3. any medical condition/medication that might compromise implant success&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Colin Campbell</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Campbell Clinic</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Colin Campbell</last_name>
    <phone>+44 115 982 3913</phone>
    <email>info@campbell-clinic.co.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kath Hare</last_name>
    <phone>+44 115 982 3913</phone>
    <email>kath@campbell-clinic.co.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The Campbell Clinic</name>
      <address>
        <city>Nottingham</city>
        <zip>NG2 7JS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Colin Campbell</last_name>
      <phone>01159823913</phone>
    </contact>
    <contact_backup>
      <last_name>Kath Hare</last_name>
      <phone>01159823913</phone>
      <email>kath@campbell-clinic.co.uk</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 26, 2016</study_first_posted>
  <last_update_submitted>June 15, 2023</last_update_submitted>
  <last_update_submitted_qc>June 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>dental implants</keyword>
  <keyword>edentulous</keyword>
  <keyword>dental hygiene</keyword>
  <keyword>evidence-based dentistry</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03003052
org study id: TCC-RD-01
nct id: NCT03003052
lead sponsor: 
has dmc: No
This purpose of this database is to collect, store and use appropriately derived data from
      routine patient care in a specialist dental practice. Comprehensive observational data will
      be gathered, systematically organised and be continuously updated. This data will be used to
      evaluate treatment outcomes and identify areas for improvement. This will contribute to the
      existing evidence base to validate new and current clinical concepts in dentistry. Patient
      consent will be sought for this, and all data extracted from patient notes will be stored and
      used anonymously. Use of the Oral Health Impact Profile (OHIP) -14 questionnaire pre and post
      treatment will be used to assess patient satisfaction with outcomes.
Specialist dentistry uses a combination of techniques resulting from joint decisions between
      clinicians and patients, aimed at giving the patient what is perceived to be the best
      possible outcome. However, as new techniques and approaches develop, there is capacity for
      more evidence to justify one treatment option over another, both clinically and most
      importantly, from the patient perspective.

      The aim of this project is to set up a research database which will enable the collection and
      storage of appropriately derived data from routine patient care and from patient
      questionnaires (using OHIP-14). This data will be used in cohort studies/case series
      reports/comparative studies with other practices.

      It is believed that this process will provide an effective way of evidencing predictable
      outcomes, assist in the development of improved clinical techniques, provide additional
      guidance and support for patients, and further clinical research in dental practice. In
      addition, implementation of studies to track patient satisfaction with clinical outcomes will
      provide advanced support in the decision making process.

      All adult patients treated at The Campbell Clinic will be approached for consent. This will
      be an ongoing process, to maximize sample size. Treatment decisions will be continue to be
      made jointly by clinician and patient and will not be altered by participation in this study.
      Patient consent will be sought, and all data will be anonymised for storage in the database.
observational model: Cohort
time perspective: Prospective
measure: Implant Success - clinical measures
time frame: up to 4 years
description: Assessment of implant success (signs of implant mucositis peri-implantitis), functionality and aesthetic results. Categorised/grouped by surgery type: single/multiple implant, use of sinus lift, and other variables.
measure: Implant Success - patient defined
time frame: up to 4 years
description: Assessment of functionality and aesthetic results from patient perspective - measured using OHIP-14 patient questionnaire.
intervention type: Procedure
intervention name: Dental implants
description: Data collection from pre-implant assessment, implant surgery, and hygiene recall appointments, to assess implant survival and success.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Colin Campbell
role: Principal Investigator
affiliation: The Campbell Clinic
last name: Colin Campbell
phone: +44 115 982 3913
email: info@campbell-clinic.co.uk
last name: Kath Hare
phone: +44 115 982 3913
email: kath@campbell-clinic.co.uk
facility: 
status: Recruiting
contact: 
contact backup: 
country: United Kingdom
responsible party type: Sponsor
sharing ipd: No