- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06761664
Decreasing Edema with Platysma Exercises Following Third Molar Extraction Surgery
January 6, 2025 updated by: Melek Volkan Yazici
Decreasing Edema with Platysma Exercises Following Third Molar Extraction Surgery: a Randomized Controlled Trial
This study will investigate the effects of a platysma muscle exercise on edema following third molar extraction surgery.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The investigators hypothesized that, during the muscle contraction of the platysma, the vascular structures will be subjected to a pump effect, leading to an increase in venous circulation.
Additionally, due to its connection to the fascia, the investigators propose that platysma contractions may mobilize the fascia and stimulate the lymph nodes, thereby improving interstitial fluid flow.
This could lead to an effective treatment option for decreasing edema after third molar tooth extraction.
Therefore, this study aims to investigate the effects of platysma exercises applied after third molar tooth extraction on edema while observing the differences on pain and trismus.
Study Type
Interventional
Enrollment (Actual)
31
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Cankaya
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Ankara, Cankaya, Turkey, 06560
- Ankara University, Faculty of Dentistry
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients aged 18-40,
- Those requiring impacted third molar extraction
- Those with no systemic health conditions, were included in the study
- Those who accepted to participate in the study
Exclusion Criteria:
- Those who had systemic diseases
- Those who were taking medications that could interfere with inflammation, or healing,
- Those who were pregnant or breastfeeding,
- Those who had infections or pathologies involving teeth 38 and 48,
- Those who were unable to comply with postoperative recommendations or required therapeutic interventions outside the study protocol
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
Participants in this group will perform exercises of the platysma muscle after third molar extraction surgery.
|
The participants in this group will perform a platysma exercise for 7 days following third molar extraction surgery.
|
|
Active Comparator: Control (Usual treatment)
Participants in this group will undergo routine treatment after third molar extraction surgery.
|
Participants in this group will receive routine treatment following third molar extraction.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Facial Edema
Time Frame: Change of facial edema from baseline to 7 days
|
Edema will be measured by taking five distinct facial measurements using a standard plastic tape measure (accuracy ±0.5 mm), ensuring the tape makes contact with the skin.
The following measurements will be recorded: (a) the distance between the most posterior point of the tragus and the most lateral point of the lip commissure; (b) from the tragus to the chin mid point; (c) from the tragus to the lateral canthus of the eye; (d) from the lateral canthus to the lowest point of the mandibular angle; and (e) from the mandibular angle to the middle of the nasal bone.
|
Change of facial edema from baseline to 7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain following third molar extraction
Time Frame: Change in pain scores from baseline to 7 days
|
Pain will be assessed using a 100 mm visual analog scale.
Patients will be asked to mark the point on the scale that best represented their level of pain.
The scale ranges from 0, indicating no pain, to 10, representing the worst pain imaginable pain.
|
Change in pain scores from baseline to 7 days
|
|
Trismus
Time Frame: Change of trismus from baseline to 7 days
|
Trismus will be assessed by measuring the maximum inter-incisal distance using callipers to record the widest mouth opening.
|
Change of trismus from baseline to 7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: GOKHAN YAZICI, A/Prof, Gazi University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 17, 2024
Primary Completion (Actual)
August 30, 2024
Study Completion (Actual)
November 4, 2024
Study Registration Dates
First Submitted
January 1, 2025
First Submitted That Met QC Criteria
January 1, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 6, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Platysma
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Due to ethical reasons data can not be directly shared.
Data can be provided upon request.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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