NCT06787027

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
6.4 years until next milestone

First Submitted

Initial submission to the registry

January 16, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 22, 2025

Completed
Last Updated

January 22, 2025

Status Verified

January 1, 2025

Enrollment Period

6 months

First QC Date

January 16, 2025

Last Update Submit

January 16, 2025

Conditions

Keywords

impacted lower third molar3dMDManual Lymphatic Drainageedema

Outcome Measures

Primary Outcomes (1)

  • postoperative facial swelling

    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 Outcomes (2)

  • Pain

    one week

  • Mouth opening

    one week

Study Arms (2)

Manual Lymphatic Drainage technique

EXPERIMENTAL

Following the morning surgery, MLD therapy was administered in the afternoon of the same day by a professional physiotherapist

Procedure: Manual Lymphatic Drainage techniqueProcedure: Conventional Treatment group

Conventional treatment

EXPERIMENTAL

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.

Procedure: Manual Lymphatic Drainage techniqueProcedure: Conventional Treatment group

Interventions

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

Conventional treatmentManual Lymphatic Drainage technique

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.

Conventional treatmentManual Lymphatic Drainage technique

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • good general health conditions;
  • presence of bilateral and symmetrical impacted third molars (according to the classifications of Winter and Pell and Gregory);

You may not qualify if:

  • no clinical evidence of major facial asymmetry;
  • use of medication that would influence or alter wound healing;
  • temporomandibular joint disorder history;
  • smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir Katip Çelebi University

Izmir, Çiğli, 35575, Turkey (Türkiye)

Location

Related Publications (1)

  • Ulu M, Unal N, Sahin O, Kayali Y. 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. BMC Oral Health. 2025 Mar 26;25(1):438. doi: 10.1186/s12903-025-05817-6.

MeSH Terms

Conditions

EdemaPainTrismus

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsNeurologic ManifestationsSpasmNeuromuscular ManifestationsNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Split-mouth model
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 16, 2025

First Posted

January 22, 2025

Study Start

March 1, 2018

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

January 22, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations