NCT07835373

Brief Summary

This randomized controlled clinical trial evaluated the effects of advanced platelet-rich fibrin (A-PRF) and hyaluronic acid (HA) on healing after surgical removal of impacted mandibular third molars. Participants were assigned to one of three groups: A-PRF applied to the extraction socket, HA applied to the extraction socket, or a control group receiving no additional biomaterial. Postoperative pain, facial swelling, and maximum mouth opening were assessed during the first postoperative week. Radiographic bone healing was evaluated using fractal dimension and mean gray value measurements on panoramic radiographs obtained on postoperative days 7 and 90. The study aimed to determine whether A-PRF or HA could improve postoperative clinical recovery and radiographic bone healing compared with standard treatment alone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2025

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

August 11, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 22, 2026

Completed
Last Updated

September 29, 2026

Status Verified

September 1, 2026

Enrollment Period

11 months

First QC Date

September 17, 2026

Last Update Submit

September 24, 2026

Conditions

Keywords

Hyaluronic acidimpacted third molarfractal analysisRadiographic gray valueadvanced platelet-rich fibrin

Outcome Measures

Primary Outcomes (1)

  • Fractal Dimension of the Extraction Socket

    Fractal dimension (FD) was used to evaluate the trabecular bone pattern within the extraction socket on digital panoramic radiographs. A standardized 32 × 32-pixel region of interest was selected at the center of the extraction socket, and FD was calculated using the box-counting method in ImageJ.

    Postoperative days 7 and 90

Secondary Outcomes (4)

  • Mean Radiographic Gray Value

    Postoperative days 7 and 90

  • Postoperative Pain

    Postoperative days 1, 3, and 7

  • Postoperative Facial Swelling

    Baseline and postoperative days 1, 3, and 7

  • Maximum Mouth Opening

    Baseline and postoperative days 1, 3, and 7

Study Arms (3)

A-PRF Group

EXPERIMENTAL

Advanced platelet-rich fibrin (A-PRF) was applied to the extraction socket following surgical removal of the impacted mandibular third molar.

Biological: Advanced Platelet-Rich Fibrin

Hyaluronic Acid Group

EXPERIMENTAL

One milliliter of 0.8% sodium hyaluronate gel was applied to the extraction socket following surgical removal of the impacted mandibular third molar.

Drug: Sodium hyaluronate

Control Group

NO INTERVENTION

No additional biomaterial was applied to the extraction socket following surgical removal of the impacted mandibular third molar. Participants received the same surgical procedure and standard postoperative care as the other groups.

Interventions

One milliliter of 0.8% sodium hyaluronate gel was applied directly into the extraction socket immediately after surgical removal of the impacted mandibular third molar.

Hyaluronic Acid Group

Advanced platelet-rich fibrin (A-PRF) was prepared from autologous venous blood by centrifugation at 1500 rpm for 14 minutes. The resulting A-PRF membrane was placed into the extraction socket immediately after surgical removal of the impacted mandibular third molar.

A-PRF Group

Eligibility Criteria

Age19 Years - 29 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients aged 19-29 years. American Society of Anesthesiologists (ASA) physical status I. Presence of an impacted mandibular third molar indicated for surgical removal. Ability and willingness to comply with the study procedures and follow-up visits.
  • Provision of written informed consent.

You may not qualify if:

  • Smoking. Poor oral hygiene. Presence of acute infection in the surgical area. Presence of a cystic or tumoral lesion associated with the impacted tooth. Uncontrolled periodontal disease. Refusal to participate or withdrawal of consent. Use of analgesics or antibiotics within 12 hours before surgery. Surgical procedure lasting longer than 40 minutes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu University Faculty of Dentistry

Malatya, Battalgazi, 44200, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Hyaluronic Acid

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

September 17, 2026

First Posted

September 22, 2026

Study Start

August 11, 2025

Primary Completion

June 30, 2026

Study Completion

June 30, 2026

Last Updated

September 29, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will share

De-identified individual participant data underlying the results reported in the published article will be shared. These data will include demographic characteristics, group allocation, postoperative pain scores, facial swelling measurements, maximum mouth opening measurements, fractal dimension values, and mean radiographic gray values.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
The study will be prepared for publication as a manuscript within six months.
Access Criteria
All individual participant data (IPD) and supporting information will be available after publication of the article.

Locations