NCT07604584

Brief Summary

Mandibular third molar surgery is commonly associated with postoperative pain, swelling, and trismus. Platelet-rich fibrin (PRF) has been proposed as a biological adjunct to improve postoperative healing; however, its effectiveness in smokers remains unclear. This prospective randomized split-mouth clinical study aimed to evaluate the effects of PRF on postoperative pain, swelling, trismus, and analgesic consumption after impacted mandibular third molar surgery in smokers and nonsmokers. Thirty patients with bilaterally impacted mandibular third molars were included. PRF was placed in one extraction socket, while the contralateral socket served as the control site. Postoperative clinical outcomes were assessed during the first postoperative week and compared between smoking and nonsmoking patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2017

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

May 15, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2018

Completed
7.4 years until next milestone

First Submitted

Initial submission to the registry

May 17, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 22, 2026

Completed
Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

1.6 years

First QC Date

May 17, 2026

Last Update Submit

May 17, 2026

Conditions

Keywords

Platelet-Rich FibrinMandibular Third MolarPostoperative PainSmokingSwellingTrismus

Outcome Measures

Primary Outcomes (1)

  • Postoperative Pain Intensity

    Postoperative pain intensity assessed using a 100-mm visual analog scale (VAS) after impacted mandibular third molar surgery.

    Postoperative days 1, 2, 3, and 7

Secondary Outcomes (3)

  • Postoperative Facial Swelling

    Preoperative period and postoperative days 1, 2, 3, and 7

  • Postoperative Trismus

    Preoperative period and postoperative days 1, 2, 3, and 7

  • Postoperative Analgesic Consumption

    Postoperative days 1, 2, 3, and 7

Study Arms (2)

PRF-treated socket

EXPERIMENTAL

Platelet-rich fibrin (PRF) was placed into the extraction socket following impacted mandibular third molar surgery.

Biological: Platelet-Rich Fibrin

Control socket

NO INTERVENTION

The contralateral extraction socket was primarily closed without PRF application after mandibular third molar surgery.

Interventions

Autologous platelet-rich fibrin prepared from venous blood by centrifugation and placed into the extraction socket after mandibular third molar extraction.

PRF-treated socket

Eligibility Criteria

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

You may qualify if:

  • Systemically healthy patients aged between 18 and 35 years
  • Bilaterally impacted mandibular third molars
  • Mandibular third molars classified as Pell and Gregory Class I, Position C
  • Mandibular third molars classified as Parant Class II difficulty
  • Smoking and nonsmoking patients
  • Patients willing to participate and provide written informed consent

You may not qualify if:

  • Presence of acute infection or pericoronitis
  • Pregnancy or lactation
  • Alcohol or substance abuse
  • Use of oral contraceptives
  • Menstrual period during surgery
  • Antibiotic use within the previous month
  • Smoking more than 10 cigarettes per day
  • Agitation or inability to cooperate
  • Incomplete follow-up data
  • Systemic disease contraindicating oral surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University Faculty of Dentistry

Ankara, 06560, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, PostoperativeTrismusSmoking

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsSpasmNeuromuscular ManifestationsNervous System DiseasesBehavior

Study Officials

  • Mehmet Emre Yurttutan, PhD, DDS

    Ankara University, Faculty of Dentistry, Department of Oral and Maxillofacial Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: This study was designed as a prospective randomized split-mouth clinical trial in which PRF was applied to one extraction socket, while the contralateral extraction socket served as the control site without PRF application. Bilateral mandibular third molar extractions were performed at least two weeks apart in the same patients. Smoking status was evaluated as a subgroup factor.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

May 17, 2026

First Posted

May 22, 2026

Study Start

May 15, 2017

Primary Completion

December 21, 2018

Study Completion

December 21, 2018

Last Updated

May 22, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations