NCT06761664

Brief Summary

This study will investigate the effects of a platysma muscle exercise on edema following third molar extraction surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 17, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 1, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 7, 2025

Completed
Last Updated

January 8, 2025

Status Verified

January 1, 2025

Enrollment Period

1 month

First QC Date

January 1, 2025

Last Update Submit

January 6, 2025

Conditions

Keywords

Third molar extractionPlatysma muscleExerciseEdema

Outcome Measures

Primary Outcomes (1)

  • Facial Edema

    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 Outcomes (2)

  • Pain following third molar extraction

    Change in pain scores from baseline to 7 days

  • Trismus

    Change of trismus from baseline to 7 days

Study Arms (2)

Intervention

EXPERIMENTAL

Participants in this group will perform exercises of the platysma muscle after third molar extraction surgery.

Other: Platysma Exercise Group

Control (Usual treatment)

ACTIVE COMPARATOR

Participants in this group will undergo routine treatment after third molar extraction surgery.

Other: Control (Standard treatment)

Interventions

The participants in this group will perform a platysma exercise for 7 days following third molar extraction surgery.

Intervention

Participants in this group will receive routine treatment following third molar extraction.

Control (Usual treatment)

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University, Faculty of Dentistry

Ankara, Cankaya, 06560, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor ActivityEdema

Condition Hierarchy (Ancestors)

BehaviorSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • GOKHAN YAZICI, A/Prof

    Gazi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assoc Prof.

Study Record Dates

First Submitted

January 1, 2025

First Posted

January 7, 2025

Study Start

July 17, 2024

Primary Completion

August 30, 2024

Study Completion

November 4, 2024

Last Updated

January 8, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Due to ethical reasons data can not be directly shared. Data can be provided upon request.

Locations