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Completed

NCT Number: NCT06787027

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Izmir Katip Çelebi University

Izmir, Çiğli, 35575, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Manual Lymphatic Drainage technique

Procedure

Following the morning surgery, manual lymphatic drainage therapy was administered in the afternoon of the same day by a professional physiotherapist.

Conventional Treatment group

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Pain

    Time frame: one week

    VAS measure

  2. 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.

Sponsors and collaborators

Lead sponsor

Izmir Katip Celebi University

Other

Registry information

Official study title

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

Acronym: wisdom tooth

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 22, 2025
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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