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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04967131
Other study ID # 10840098-604.01.01-E.60748
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 7, 2020
Est. completion date December 31, 2022

Study information

Verified date April 2021
Source Istanbul Medipol University Hospital
Contact Gizem Ergezen, MSc
Phone +905347098414
Email gizem-ergezen@hotmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Individuals who were diagnosed with reduction disc displacement by Research Diagnostic criteria for Temporomandibular Disorder (TMD / RDC) were included in the study. Proprioceptive neuromuscular facilitation exercises were performed for 30 minutes using neck jaw and tongue patterns with rhythmic stabilization (RS) and combination of isotonics (CI) techniques by physiotherapist. Maximal mouth openings were measured with caliper, pain intensities were measured with visual analogue scale and pressure pain thresholds with hand algometer.


Description:

TMD patients who are diagnosed by TMD/RDC are firstly assessed by physiotherapist for maximal mouth opening(MMO), pain intensity and pressure pain threshold. Then they will taught exercises with rhythmic initiation which includes repetation of the patern and 15 repetitions are applied as warm-up period. Proprioceptive neuromuscular facilitation (PNF) exercises are performed in the neck and jaw patterns with rhythmic stabilization (RS) and combination of isotonics (CI) techniques. In the neck, right rotation-right lateral flexion, left rotation-left lateral flexion pattern, and the opening and closing pattern according to the working mechanics of the masseter and temporal muscle in the chin, RS and CI techniques are used. By providing maximum resistance in accordance with the needs of each individual, the RS protocol consist of isometric contractions that would not involve changing movements for 10 seconds. The combination of isotonics technique include combined concentric, isometric, and eccentric contraction of the agonist muscle for 5 seconds of each contraction without rest. CI exercises consist of 15 repetitions per set. A 30-second rest given between sets to include recovery. After exercises immediate MMO, pain intensity and pain treshold assessment will be applied.


Recruitment information / eligibility

Status Recruiting
Enrollment 25
Est. completion date December 31, 2022
Est. primary completion date December 1, 2021
Accepts healthy volunteers
Gender Female
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria: - Volunteers between 18-25 years female, admitted to the study with clenching, grinding, clicking, jaw pain when eating hard foods, and limited and painful mouth movements. Exclusion Criteria: - Having orthopedic, neurological or rheumatological cervical disorders which affect the jaw motions; receiving occlusal therapy as a companion to treatment, those who have an operation in the area of jaw, head and neck and those with vertigo that prevents head movements during exercises.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
PNF exercises
PNF exercises were applied in 3 sets of 15 repetitions based on movement in the diagonal plane, using head, neck and chin patterns. Contractions were sustained for at least 10 seconds.

Locations

Country Name City State
Turkey Istanbul Medipol University Istanbul Beykoz

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain Treshold The pain threshold will be measured with an algometer at certain points on the muscles in the area where the exercise is applied. the immediate effect will be measured as soon as the exercise is finished
Primary Pain intensity The level of pain felt will be marked with a visual analog scale on a 10-centimeter paper. the immediate effect will be measured as soon as the exercise is finished
Primary Maximum mouth opening Individuals will be asked to open their mouths as much as they can, and mouth opening will be measured with a caliper. the immediate effect will be measured as soon as the exercise is finished
Secondary Unassisted opening the individual is told to open their mouth and the gap is measured with a caliper. the immediate effect will be measured as soon as the exercise is finished
Secondary maximum unassisted opening Without trying to increase the mouth opening with hand or any help, the individual actively opens mouth as much as they can and the opening is measured with a caliper. the immediate effect will be measured as soon as the exercise is finished
Secondary maximum assisted opening It is measured with a caliper by asking individuals to open their mouths as much as they can and open more by helping with their hands at the last point. the immediate effect will be measured as soon as the exercise is finished
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