- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06787027
Effect of Manual Massage Technique on Swelling, Pain and Mouth Opening After Bilateral Lower Third Molar Surgery (wisdom tooth)
Evaluation of the Effect of Manual Lymphatic Drainage Method on Edema, Pain and Trismus After Impacted Bilateral Mandibular Third Molar Surgery: a Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is a randomized controlled split-mouth trial. A total of 46 healthy patients who presented to our department for the extraction of impacted mandibular third molars were included in this study.The inclusion criteria were as follows: presence of pericoronal infection, no recent use of anti-inflammatory medications, symmetrical impactions on both sides, asymptomatic cases, and class 2, position B or C, vertical and mesioangular impactions. Impactions were classified using the Pell and Gregory classification system.
Exclusion criteria included patients who declined participation, pregnant or lactating individuals, patients with penicillin allergies, those with chronic diseases that could affect healing, uncooperative patients. Following the surgery, manual lymphatic drainage therapy was administered in the afternoon of the same day by a professional physiotherapist using the "Vodder" technique. In this study, measurements were conducted by two researchers. Swelling and trismus values were recorded preoperatively (T0), on the 3rd postoperative day (T1), and on the 7th postoperative day (T2). To assess pain, the VAS was used and values were recorded 1, 2, 3 and 7 days postoperatively. In this study, edema was evaluated using the 3dMD FACE SYSTEM (3dMD, Atlanta, GA), which virtually transfers the patient's face into 3D, allowing for the calculation of volume changes.To assess pain, the Visual Analog Scale (VAS) was used.To determine the effect of MLD therapy on postoperative trismus, the distance between the upper and lower incisors was measured using a digital caliper immediately before the operation, as well as on the 3rd and 7th postoperative days
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Çiğli
-
İzmir, Çiğli, Turkey, 35575
- İzmir Katip Çelebi University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- good general health conditions;
- presence of bilateral and symmetrical impacted third molars (according to the classifications of Winter and Pell and Gregory);
Exclusion Criteria:
- no clinical evidence of major facial asymmetry;
- use of medication that would influence or alter wound healing;
- temporomandibular joint disorder history;
- smoking
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Manual Lymphatic Drainage technique
Following the morning surgery, MLD therapy was administered in the afternoon of the same day by a professional physiotherapist
|
Following the morning surgery, manual lymphatic drainage therapy was administered in the afternoon of the same day by a professional physiotherapist.
patients were prescribed antibiotics (amoxicillin with clavulanic acid, 1 g, twice daily), analgesics (paracetamol, 500 mg, twice daily), and mouthwash (chlorhexidine gluconate, three times daily) for five days.
Cold application was recommended to all patients.
|
|
Experimental: Conventional treatment
Postoperatively, patients were prescribed antibiotics (amoxicillin with clavulanic acid, 1 g, twice daily), analgesics (paracetamol, 500 mg, twice daily), and mouthwash (chlorhexidine gluconate, three times daily) for five days.
|
Following the morning surgery, manual lymphatic drainage therapy was administered in the afternoon of the same day by a professional physiotherapist.
patients were prescribed antibiotics (amoxicillin with clavulanic acid, 1 g, twice daily), analgesics (paracetamol, 500 mg, twice daily), and mouthwash (chlorhexidine gluconate, three times daily) for five days.
Cold application was recommended to all patients.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
postoperative facial swelling
Time Frame: one week
|
Facial swelling T0-T1 and T0-T2 scans are opened and superimposed through three reference points: endocanthion left (inner most point on commissure of left eye fissure), endocanthion right (inner most point on commissure of right eye fissure) and subnasale (mid point of columella). After matching, the swelling was calculated by selecting the area of the swelling and subtracting the two images. |
one week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain
Time Frame: one week
|
VAS measure
|
one week
|
|
Mouth opening
Time Frame: one week
|
measurement of the maximal distance between the cutting edge of the right maxillary and right mandibular central incisors with a caliper.
|
one week
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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