NCT06900894

Brief Summary

This study investigates the effectiveness of Platelet-Rich Fibrin (PRF) and Kinesio Taping in reducing postoperative pain, edema, and improving recovery following impacted third molar surgery. A prospective, randomized clinical trial was conducted with 44 patients aged 18-35 years. Patients were assigned to three groups: (1) PRF applied locally to the extraction socket, (2) Kinesio Taping applied postoperatively and removed on the third day, and (3) a control group receiving standard postoperative care. Postoperative outcomes were assessed on days 3 and 7, including pain levels, edema, and quality of life. This study aims to evaluate PRF and Kinesio Taping as non-pharmacological adjuncts in oral and maxillofacial surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

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

October 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 21, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 28, 2025

Completed
Last Updated

April 2, 2025

Status Verified

March 1, 2025

Enrollment Period

3 months

First QC Date

March 17, 2025

Last Update Submit

March 28, 2025

Conditions

Keywords

Impacted third molarelastic bandageplatelet-rich fibrinpostoperative painquality of lifePostoperative Edema

Outcome Measures

Primary Outcomes (3)

  • Postoperative Pain Assessment (NRS)

    The pain intensity of the patients will be assessed using the Numerical Rating Scale (NRS) on preoperative day 1 and postoperative days 3 and 7. On this scale: 0 indicates no pain, 10 indicates the worst imaginable pain. Before the procedure, patients were informed about the scale and instructed to rate their pain intensity accordingly.

    Preoperative day 1, postoperative days 3 and 7

  • Postoperative Facial Swelling Assessment

    Swelling will be evaluated using anthropometric measurement techniques on preoperative (surgery day), postoperative days 1, 3, and 7. Measurement methods: Lateral canthus-gonion distance (distance from the outer corner of the eye to the mandibular angle) Commissure-tragus distance (distance from the oral commissure to the midpoint of the tragus) All measurements were performed using a flexible ruler, and the results were recorded in millimeters.

    Preoperative day 1, postoperative days 3 and 7

  • Oral Health Impact Profile-14 (OHIP-14) Score

    The quality of life of the patients will be assessed using the OHIP-14 questionnaire on postoperative days 3 and 7. OHIP-14 consists of 14 standardized items, each rated on a scale from 0 to 4. Total scores range from 0 to 56, with higher scores indicating worse quality of life. This scale was used to evaluate the impact of postoperative complications on patients' quality of life.

    Postoperative days 3 and 7

Study Arms (3)

PRF Group

EXPERIMENTAL

Participants in this group received Platelet-Rich Fibrin (PRF) applied to the extraction socket following impacted third molar surgery. PRF was prepared using a centrifugation protocol and placed into the surgical site.

Biological: Platelet-Rich Fibrin (PRF)

Kinesio Taping Group

EXPERIMENTAL

Participants in this group received Kinesio Taping applied postoperatively. The elastic therapeutic tape was applied to the masseter and submandibular region following a standardized taping protocol.

Device: Kinesio Taping

Control Group

OTHER

Participants in this group received standard postoperative care, including routine pain management and wound care, without additional interventions.

Other: Standard Postoperative Care

Interventions

PRF was prepared using a centrifugation protocol and applied to the extraction socket.

PRF Group

Kinesio Tape was applied postoperatively to the masseter and submandibular region.

Kinesio Taping Group

Patients in the control group received standard postoperative care.

Control Group

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Ages 18-35 years
  • Systemically healthy individuals
  • Non-smokers
  • No psychological disorders
  • Preoperative pain level between 0-3 on the Numerical Rating Scale (NRS)
  • No preoperative edema in the surgical area
  • Impacted mandibular third molars classified as Class 1 or 2, Level B, and mesioangular according to the Pell-Gregory classification
  • Signed an informed consent form

You may not qualify if:

  • Under 18 or over 35 years old
  • Presence of chronic or systemic diseases
  • Pregnant or breastfeeding patients
  • Surgical duration exceeding 45 minutes
  • Smokers
  • Patients requiring prophylactic antibiotics due to systemic health conditions
  • Patients who did not meet the study criteria or did not sign the informed consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hatay Mustafa Kemal University, Faculty of Dentistry

Hatay, 31001, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • züleyha başar karakuzu, DDS

    Mustafa Kemal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study follows a parallel assignment model in which participants are randomly allocated into three groups: Platelet-Rich Fibrin (PRF), Kinesio Taping, and Control. Each group receives a distinct intervention to evaluate the effectiveness of these non-pharmacological approaches in managing postoperative pain, edema, and recovery following impacted third molar surgery.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DDS, Oral and Maxillofacial Surgeon

Study Record Dates

First Submitted

March 17, 2025

First Posted

March 28, 2025

Study Start

October 1, 2023

Primary Completion

January 10, 2024

Study Completion

May 21, 2024

Last Updated

April 2, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

The individual participant data (IPD) collected during the study will not be shared due to confidentiality and ethical considerations. Data will only be used for statistical analysis and publication purposes in an aggregated and anonymized form.

Locations