NCT07530068

Brief Summary

This study aims to compare platelet-rich fibrin (PRF) and an absorbable collagen sponge in extraction sockets following impacted mandibular third molar removal in terms of postoperative clinical healing and periodontal and radiographic outcomes of adjacent second molars. Twenty-nine systemically healthy patients with bilaterally symmetrical impacted mandibular third molars will be included, and a total of 58 extraction sockets will be analyzed. Patients will be randomized using a sealed-envelope method into either the PRF group or the absorbable collagen sponge (Surgispon) group. In this split-mouth design, one side will receive the intervention and the contralateral side will serve as a control. Clinical and periodontal parameters will be recorded postoperatively, and radiographic healing will be evaluated using fractal analysis and lacunarity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 28, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 31, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 15, 2026

Completed
Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

9 months

First QC Date

March 31, 2026

Last Update Submit

April 8, 2026

Conditions

Impacted Mandibular Third MolarWound HealingPostoperative Pain

Keywords

Platelet-Rich Fibrin (PRF)Absorbable Collagen SpongeMandibular Third Molar SurgerySplit-Mouth DesignPostoperative PainWound HealingAlveolar Bone Healing

Outcome Measures

Primary Outcomes (2)

  • Fractal Dimension and Lacunarity Values for Bone Healing

    Radiographic bone healing in the extraction socket will be evaluated using fractal analysis and lacunarity measurements derived from standardized radiographs.

    12 weeks postoperatively

  • Postoperative Pain Score (Visual Analog Scale)

    Postoperative pain will be assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where higher scores indicate greater pain.

    3 days postoperatively

Secondary Outcomes (6)

  • Facial Swelling Distance (Tragus-Commissure and Tragus-Pogonion Measurements in mm)

    posoperatively 3 days

  • Number of Participants with Alveolar Osteitis (Clinical Diagnosis)

    post op 7 days

  • Mean Periodontal Probing Depth (mm) at Distal Surface of Mandibular Second Molar

    post op 7 days

  • Mean Gingival Recession (mm) at Distal Surface of Mandibular Second Molar

    post op 7 days

  • Gingival Index Score (Löe and Silness Index, 0-3 Scale)

    post op 7 days

  • +1 more secondary outcomes

Study Arms (4)

Platelet-Rich Fibrin (PRF)

EXPERIMENTAL

n this split-mouth design, platelet-rich fibrin (PRF) is applied to the extraction socket of the impacted mandibular third molar on the allocated side following tooth removal. The contralateral side serves as an untreated control.

Biological: Platelet-rich fibrin (PRF)

Control (PRF group)

NO INTERVENTION

In this split-mouth design, no material is applied to the extraction socket on the control side following mandibular third molar removal. Standard postoperative care is provided

Collagen Sponge (Surgispon)

EXPERIMENTAL

In this split-mouth design, an absorbable collagen sponge (Spongostan) is placed into the extraction socket on the allocated side following mandibular third molar removal. The contralateral side serves as an untreated control.

Biological: Absorbable Collagen Sponge

Control (Spongostan group)

NO INTERVENTION

In this split-mouth design, no material is applied to the extraction socket on the control side following mandibular third molar removal. Standard postoperative care is provided.

Interventions

Platelet-rich fibrin (PRF)BIOLOGICAL

Platelet-rich fibrin (PRF) is prepared from autologous venous blood by centrifugation without the use of anticoagulants. The obtained fibrin clot is placed into the extraction socket immediately after mandibular third molar removal to promote wound healing and reduce postoperative complications.

Platelet-Rich Fibrin (PRF)
Absorbable Collagen SpongeBIOLOGICAL

An absorbable collagen sponge is placed into the extraction socket immediately after mandibular third molar removal. The material is used to support hemostasis and promote wound healing. No additional biomaterials are applied.

Also known as: spongostan, surgispon
Collagen Sponge (Surgispon)

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Presence of bilaterally impacted mandibular third molars
  • Indication for extraction due to recurrent pericoronitis, non-restorable caries, or periodontal or orthodontic reasons
  • Age between 18 and 30 years
  • Systemically healthy individuals

You may not qualify if:

  • Presence of acute infection or pathology in the surgical region
  • Systemic or immunological disease
  • Uncontrolled diabetes mellitus
  • History of chemotherapy or radiotherapy
  • Use of anticoagulants, steroids, or medications affecting bone metabolism
  • Pregnancy
  • Smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Ankara, Ankara, 06490, Turkey (Türkiye)

Location

Related Publications (5)

  • Kim JW, Seong TW, Cho S, Kim SJ. Randomized controlled trial on the effectiveness of absorbable collagen sponge after extraction of impacted mandibular third molar: split-mouth design. BMC Oral Health. 2020 Mar 18;20(1):77. doi: 10.1186/s12903-020-1063-3.

    PMID: 32183831RESULT

  • Zwittnig K, Kirnbauer B, Truschnegg A, Jakse N, Wolf A, Sokolowski A, Mischak I, Payer M. Effectiveness of platelet-rich fibrin in third molar extractions: a randomized controlled split-mouth study. Clin Oral Investig. 2024 Oct 29;28(11):615. doi: 10.1007/s00784-024-06002-9.

    PMID: 39467892RESULT

  • Mettes TD, Ghaeminia H, Nienhuijs ME, Perry J, van der Sanden WJ, Plasschaert A. Surgical removal versus retention for the management of asymptomatic impacted wisdom teeth. Cochrane Database Syst Rev. 2012 Jun 13;(6):CD003879. doi: 10.1002/14651858.CD003879.pub3.

    PMID: 22696337RESULT

  • Chiapasco M, De Cicco L, Marrone G. Side effects and complications associated with third molar surgery. Oral Surg Oral Med Oral Pathol. 1993 Oct;76(4):412-20. doi: 10.1016/0030-4220(93)90005-o.

    PMID: 8233418RESULT

  • Susarla SM, Dodson TB. Risk factors for third molar extraction difficulty. J Oral Maxillofac Surg. 2004 Nov;62(11):1363-71. doi: 10.1016/j.joms.2004.05.214.

    PMID: 15510357RESULT

Related Links

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Fibrin Foam

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

FibrinBlood ProteinsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Nur Mollaoglu, OMFS PROFESSOR

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

    PRINCIPAL INVESTIGATOR

  • Ahmet Talha OSMANOĞLU, OMFS RESİDENT

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: This randomized split-mouth clinical trial includes two parallel split-mouth cohorts. In one cohort, participants with bilaterally impacted mandibular third molars are randomly assigned to receive platelet-rich fibrin (PRF) on one side, while the contralateral side serves as an untreated control. In the second cohort, participants are randomly assigned to receive an absorbable collagen sponge (Spongostan) on one side, while the contralateral side serves as an untreated control. Thus, each participant serves as their own control. Clinical and radiographic outcomes are evaluated at predefined postoperative time points.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Dr.

Study Record Dates

First Submitted

March 31, 2026

First Posted

April 15, 2026

Study Start

February 28, 2025

Primary Completion

November 30, 2025

Study Completion

February 28, 2026

Last Updated

April 15, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)