Effect of Manual Massage Technique on Swelling, Pain and Mouth Opening After Bilateral Lower Third Molar Surgery (wisdom tooth)

January 16, 2025 updated by: Onur ŞAHİN, Izmir Katip Celebi University

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

The aim of this study was to evaluate the effect of manual lymphatic drainage on pain, edema and trismus after impacted mandibular third molar surgery.

Study Overview

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

Interventional

Enrollment (Actual)

46

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

    • Çiğli
      • İzmir, Çiğli, Turkey, 35575
        • İzmir Katip Çelebi University

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:

  • 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

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: 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

This is where you will find people and organizations involved with this study.

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)

March 1, 2018

Primary Completion (Actual)

September 1, 2018

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

January 16, 2025

First Submitted That Met QC Criteria

January 16, 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 16, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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