<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/NCT03000790</url>
  </required_header>
  <id_info>
    <org_study_id>CairoLRS</org_study_id>
    <nct_id>NCT03000790</nct_id>
  </id_info>
  <brief_title>Evaluation Lingual Ring Splint</brief_title>
  <official_title>Clinical Evaluation of Lingual Ring Splint For Management Anterior Disc Displacement With Reduction (Pilot Study Clinical Trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the effectiveness of Lingual Ring Splint For Management of Anterior Disc&#xD;
      Displacement With Reduction&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To evaluate the effectiveness of Lingual Ring Splint For Management of Anterior Disc&#xD;
      Displacement With Reduction.&#xD;
&#xD;
      PICO P- Patient with symptomatic anterior disc displacement with reduction . I- use of&#xD;
      Michigan splint C- use of anterior repositioning splint (ARS) . O- Clinical outcome. Pain&#xD;
      relief and improvement of mouth opening , lateral excursion and protrusion&#xD;
&#xD;
      Outcome:&#xD;
&#xD;
        -  1ry outcome: Patients' subjective pain experience. Each patient will be asked to rate&#xD;
           his or her current and worst pain intensity on numerical rating scale (NRS) of 0-10 with&#xD;
           zero being no pain and ten corresponds to the worst pain that the patient ever had.&#xD;
&#xD;
        -  2ry outcome:&#xD;
&#xD;
             1. Maximum mouth opening (MMO). Assessment of MMO will be performed by measuring the&#xD;
                distance in mm between the incisal edges of the upper and lower central incisors&#xD;
                using a ruler.&#xD;
&#xD;
             2. lateral excursion . Assessment of lateral excursion will be performed by measuring&#xD;
                the distance in mm between midline of upper and lower jaws&#xD;
&#xD;
             3. protrusion. The distance in mm from the incisal edge of the maxillary central&#xD;
                incisor to the incisor edge of the mandibular incisor will measured in the maximum&#xD;
                protruded position.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">July 2017</completion_date>
  <primary_completion_date type="Anticipated">June 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patients' subjective pain experience.</measure>
    <time_frame>3 months</time_frame>
    <description>Each patient will be asked to rate his or her current and worst pain intensity on numerical rating scale (NRS) of 0-10 with zero being no pain and ten corresponds to the worst pain that the patient ever had.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum mouth opening.</measure>
    <time_frame>3 months</time_frame>
    <description>measuring the distance between the incisal edges of the upper and lower central incisors using a ruler.Unit:mm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lateral excursion.</measure>
    <time_frame>3 months</time_frame>
    <description>measuring the distance between midline of upper and lower jaws . Unit: mm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Protrusion.</measure>
    <time_frame>3 months</time_frame>
    <description>The distance in mm from the incisal edge of the maxillary central incisor to the incisor edge of the mandibular incisor will measured in the maximum protruded position.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>TMJ Disc Disorder</condition>
  <arm_group>
    <arm_group_label>Lingual Ring Splint</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A polyvinyl (polypropylene) material was chosen, which is biocompatible, nontoxic, hypoallergenic, and has a hardness of about 60-70 Shore, The thickness of 3 mm in the occlusive active portion and 2 mm in the other parts was constructed.&#xD;
The lingual ring consists of Two lateral genal shields that are vertical and symmetric, and have a right- and left-of-oval form, Two interocclusive levels with a roughly triangular form, but with round angles also right and left symmetric, double arch superior arch and inferior arch will make the Ring around the tongue</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Lingual Ring Splint</intervention_name>
    <description>A polyvinyl (polypropylene) material was chosen, which is biocompatible, nontoxic, hypoallergenic, and has a hardness of about 60-70 Shore, The thickness of 3 mm in the occlusive active portion and 2 mm in the other parts was constructed.&#xD;
The lingual ring consists of Two lateral genal shields that are vertical and symmetric, and have a right- and left-of-oval form, Two interocclusive levels with a roughly triangular form, but with round angles also right and left symmetric, double arch superior arch and inferior archwill make the Ring around the tongue</description>
    <arm_group_label>Lingual Ring Splint</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patient from 15 to 50 years old.&#xD;
&#xD;
          -  Report of pain in preauricular region, in the last 30 days, worsened by functional&#xD;
             activities, such as chewing and talking.&#xD;
&#xD;
          -  Presence of disc displacement with reduction, arthralgia and joint clicking that&#xD;
             occurred at both middle to late opening and late closing (near maximum cuspation) and&#xD;
             pain in the TMJ area aggravated by jaw movement and function.&#xD;
&#xD;
          -  positive diagnosis of unilateral or bilateral anterior disc displacement with&#xD;
             reduction by means of magnetic resonance imaging (MRI).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals with a recent history of trauma in the face and/or neck area.&#xD;
&#xD;
          -  Individuals with systemic diseases that can affect TMJ.&#xD;
&#xD;
          -  History of TMJ surgery.&#xD;
&#xD;
          -  Individuals with dental pain.&#xD;
&#xD;
          -  Individuals with myofascial pain, disc displacement with reduction or osteoarthritis.&#xD;
&#xD;
          -  Individuals under dental or TMD management.&#xD;
&#xD;
          -  Individuals wearing full or partial dentures.&#xD;
&#xD;
          -  Individuals with major psychological disorders.&#xD;
&#xD;
          -  Nonreducing dislocations of the articular disk in the acute form of TMD&#xD;
&#xD;
          -  Consequences of condoyle fractures and/or fracture of another maxillofacial zone.&#xD;
&#xD;
          -  In therapy for the same pathologies.&#xD;
&#xD;
          -  Articular pathologies of systemic nature (e.g., rheumatoid arthritis, arthrosis,&#xD;
             psoriasis arthritis).&#xD;
&#xD;
          -  Well-known pathologies of neurologic and/or psychic nature and other forms of&#xD;
             migraine.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nadia Galal, MD</last_name>
    <role>Study Director</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ahmed Nassar, BSC</last_name>
    <phone>01282533585</phone>
    <email>dentgemy1000@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ahmed El-Sharkawy, Lecturer</last_name>
  </overall_contact_backup>
  <reference>
    <citation>Srivastava R, Jyoti B, Devi P. Oral splint for temporomandibular joint disorders with revolutionary fluid system. Dent Res J (Isfahan). 2013 May;10(3):307-13.</citation>
    <PMID>24019797</PMID>
  </reference>
  <reference>
    <citation>Seifeldin SA, Elhayes KA. Soft versus hard occlusal splint therapy in the management of temporomandibular disorders (TMDs). Saudi Dent J. 2015 Oct;27(4):208-14. doi: 10.1016/j.sdentj.2014.12.004. Epub 2015 Jun 25.</citation>
    <PMID>26644756</PMID>
  </reference>
  <reference>
    <citation>Conti PC, Correa AS, Lauris JR, Stuginski-Barbosa J. Management of painful temporomandibular joint clicking with different intraoral devices and counseling: a controlled study. J Appl Oral Sci. 2015 Oct;23(5):529-35. doi: 10.1590/1678-775720140438. Epub 2015 Jul 21.</citation>
    <PMID>26200526</PMID>
  </reference>
  <reference>
    <citation>Lee HS, Baek HS, Song DS, Kim HC, Kim HG, Kim BJ, Kim MS, Shin SH, Jung SH, Kim CH. Effect of simultaneous therapy of arthrocentesis and occlusal splints on temporomandibular disorders: anterior disc displacement without reduction. J Korean Assoc Oral Maxillofac Surg. 2013 Feb;39(1):14-20. doi: 10.5125/jkaoms.2013.39.1.14. Epub 2013 Feb 21.</citation>
    <PMID>24471012</PMID>
  </reference>
  <reference>
    <citation>Liu J, Mu H, Wang Z, Lan J, Zhang S, Long X, Zhang D. Joint cavity injection combined with manual reduction and stabilization splint treatment of anterior disc displacement. Int J Clin Exp Med. 2015 Apr 15;8(4):5943-8. eCollection 2015.</citation>
    <PMID>26131189</PMID>
  </reference>
  <reference>
    <citation>Muhtarogullari M, Avci M, Yuzugullu B. Efficiency of pivot splints as jaw exercise apparatus in combination with stabilization splints in anterior disc displacement without reduction: a retrospective study. Head Face Med. 2014 Oct 9;10:42. doi: 10.1186/1746-160X-10-42.</citation>
    <PMID>25300939</PMID>
  </reference>
  <reference>
    <citation>Rampello A, Falisi G, Panti F, DI Paolo C. A new aid in TMD Therapy: the Universal Neuromuscular Immediate Relaxing appliance &quot;UNIRA&quot;. Oral Implantol (Rome). 2010 Jan;3(1):20-32. Epub 2010 Nov 19.</citation>
    <PMID>23285377</PMID>
  </reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 22, 2016</study_first_posted>
  <last_update_submitted>December 21, 2016</last_update_submitted>
  <last_update_submitted_qc>December 21, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 22, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Ahmed Gamal Nassar</investigator_full_name>
    <investigator_title>Dentist at ministry of health</investigator_title>
  </responsible_party>
  <keyword>Anterior disc displacement</keyword>
  <keyword>TMD therapy</keyword>
  <keyword>internal derangement</keyword>
  <keyword>Lingual Ring</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/NCT03000790
org study id: CairoLRS
nct id: NCT03000790
lead sponsor: 
has dmc: No
To evaluate the effectiveness of Lingual Ring Splint For Management of Anterior Disc
      Displacement With Reduction
To evaluate the effectiveness of Lingual Ring Splint For Management of Anterior Disc
      Displacement With Reduction.

      PICO P- Patient with symptomatic anterior disc displacement with reduction . I- use of
      Michigan splint C- use of anterior repositioning splint (ARS) . O- Clinical outcome. Pain
      relief and improvement of mouth opening , lateral excursion and protrusion

      Outcome:

        -  1ry outcome: Patients' subjective pain experience. Each patient will be asked to rate
           his or her current and worst pain intensity on numerical rating scale (NRS) of 0-10 with
           zero being no pain and ten corresponds to the worst pain that the patient ever had.

        -  2ry outcome:

             1. Maximum mouth opening (MMO). Assessment of MMO will be performed by measuring the
                distance in mm between the incisal edges of the upper and lower central incisors
                using a ruler.

             2. lateral excursion . Assessment of lateral excursion will be performed by measuring
                the distance in mm between midline of upper and lower jaws

             3. protrusion. The distance in mm from the incisal edge of the maxillary central
                incisor to the incisor edge of the mandibular incisor will measured in the maximum
                protruded position.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Patients' subjective pain experience.
time frame: 3 months
description: Each patient will be asked to rate his or her current and worst pain intensity on numerical rating scale (NRS) of 0-10 with zero being no pain and ten corresponds to the worst pain that the patient ever had.
measure: Maximum mouth opening.
time frame: 3 months
description: measuring the distance between the incisal edges of the upper and lower central incisors using a ruler.Unit:mm
measure: Lateral excursion.
time frame: 3 months
description: measuring the distance between midline of upper and lower jaws . Unit: mm
measure: Protrusion.
time frame: 3 months
description: The distance in mm from the incisal edge of the maxillary central incisor to the incisor edge of the mandibular incisor will measured in the maximum protruded position.
arm group label: Lingual Ring Splint
arm group type: Experimental
description: A polyvinyl (polypropylene) material was chosen, which is biocompatible, nontoxic, hypoallergenic, and has a hardness of about 60-70 Shore, The thickness of 3 mm in the occlusive active portion and 2 mm in the other parts was constructed.
The lingual ring consists of Two lateral genal shields that are vertical and symmetric, and have a right- and left-of-oval form, Two interocclusive levels with a roughly triangular form, but with round angles also right and left symmetric, double arch superior arch and inferior arch will make the Ring around the tongue
intervention type: Device
intervention name: Lingual Ring Splint
description: A polyvinyl (polypropylene) material was chosen, which is biocompatible, nontoxic, hypoallergenic, and has a hardness of about 60-70 Shore, The thickness of 3 mm in the occlusive active portion and 2 mm in the other parts was constructed.
The lingual ring consists of Two lateral genal shields that are vertical and symmetric, and have a right- and left-of-oval form, Two interocclusive levels with a roughly triangular form, but with round angles also right and left symmetric, double arch superior arch and inferior archwill make the Ring around the tongue
arm group label: Lingual Ring Splint
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Nadia Galal, MD
role: Study Director
affiliation: Cairo University
last name: Ahmed Nassar, BSC
phone: 01282533585
email: dentgemy1000@gmail.com
last name: Ahmed El-Sharkawy, Lecturer
citation: Srivastava R, Jyoti B, Devi P. Oral splint for temporomandibular joint disorders with revolutionary fluid system. Dent Res J (Isfahan). 2013 May;10(3):307-13.
PMID: 24019797
citation: Seifeldin SA, Elhayes KA. Soft versus hard occlusal splint therapy in the management of temporomandibular disorders (TMDs). Saudi Dent J. 2015 Oct;27(4):208-14. doi: 10.1016/j.sdentj.2014.12.004. Epub 2015 Jun 25.
PMID: 26644756
citation: Conti PC, Correa AS, Lauris JR, Stuginski-Barbosa J. Management of painful temporomandibular joint clicking with different intraoral devices and counseling: a controlled study. J Appl Oral Sci. 2015 Oct;23(5):529-35. doi: 10.1590/1678-775720140438. Epub 2015 Jul 21.
PMID: 26200526
citation: Lee HS, Baek HS, Song DS, Kim HC, Kim HG, Kim BJ, Kim MS, Shin SH, Jung SH, Kim CH. Effect of simultaneous therapy of arthrocentesis and occlusal splints on temporomandibular disorders: anterior disc displacement without reduction. J Korean Assoc Oral Maxillofac Surg. 2013 Feb;39(1):14-20. doi: 10.5125/jkaoms.2013.39.1.14. Epub 2013 Feb 21.
PMID: 24471012
citation: Liu J, Mu H, Wang Z, Lan J, Zhang S, Long X, Zhang D. Joint cavity injection combined with manual reduction and stabilization splint treatment of anterior disc displacement. Int J Clin Exp Med. 2015 Apr 15;8(4):5943-8. eCollection 2015.
PMID: 26131189
citation: Muhtarogullari M, Avci M, Yuzugullu B. Efficiency of pivot splints as jaw exercise apparatus in combination with stabilization splints in anterior disc displacement without reduction: a retrospective study. Head Face Med. 2014 Oct 9;10:42. doi: 10.1186/1746-160X-10-42.
PMID: 25300939
citation: Rampello A, Falisi G, Panti F, DI Paolo C. A new aid in TMD Therapy: the Universal Neuromuscular Immediate Relaxing appliance "UNIRA". Oral Implantol (Rome). 2010 Jan;3(1):20-32. Epub 2010 Nov 19.
PMID: 23285377
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Ahmed Gamal Nassar
investigator title: Dentist at ministry of health
sharing ipd: No