Adjacent Molar Outcomes After Third Molar Surgery With PRF or Collagen Sponge (PRFvsCOLL-3M)

Adjacent Molar Outcomes After Impacted Mandibular Third Molar Surgery With PRF or Collagen Sponge: A Randomized Split-Mouth Trial

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Wound Healing; Impacted Mandibular Third Molar
• Intervention / Treatment: Biological: Platelet-rich fibrin (PRF); Biological: Absorbable Collagen Sponge

Detailed Description

This study is designed as a prospective, randomized, controlled, split-mouth clinical trial to evaluate the effects of platelet-rich fibrin (PRF) and an absorbable collagen sponge on postoperative healing following impacted mandibular third molar extraction.

Impacted mandibular third molar surgery is commonly associated with postoperative complications such as pain, swelling, trismus, and delayed healing. In addition, periodontal defects on the distal surface of the adjacent second molar and delayed bone healing in the extraction socket are clinically important concerns.

PRF is an autologous biomaterial rich in growth factors that may support tissue healing and regeneration. Absorbable collagen sponges are biocompatible materials that stabilize the blood clot and provide a scaffold for tissue regeneration. However, direct comparisons of these two materials within the same patient population are limited.

A total of 29 systemically healthy patients aged between 18 and 30 years with bilaterally symmetrical impacted mandibular third molars will be included. A split-mouth design will be used, where one side will receive the intervention and the contralateral side will serve as a control. Randomization will be performed using a sealed-envelope method.

All surgical procedures will be performed under local anesthesia using a standardized protocol. Following tooth extraction, PRF or collagen sponge will be applied to the socket according to randomization, while the control side will heal naturally. All surgical sites will be sutured using a standardized technique.

Postoperative care will be standardized for all patients. Clinical evaluation will include postoperative pain, swelling, and the presence of alveolar osteitis. Periodontal evaluation will include probing depth, gingival recession, gingival index, and bleeding on probing at the distal aspect of the second molar.

Radiographic evaluation will be performed using standardized periapical radiographs. Fractal analysis and lacunarity measurements will be used to assess trabecular bone structure and healing.

Statistical analysis will be conducted using appropriate parametric or non-parametric tests based on data distribution, with a significance level set at p < 0.05.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Ankara
    • Ankara, Ankara, Turkey (Türkiye), 06490
      • Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Gazi University, Ankara, Turkey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Platelet-Rich Fibrin (PRF); 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); 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.
No Intervention: Control (PRF group); 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
Experimental: Collagen Sponge (Surgispon); 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; 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.; Other Names: spongostan; surgispon
No Intervention: Control (Spongostan group); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Facial Swelling Distance (Tragus-Commissure and Tragus-Pogonion Measurements in mm)	Postoperative facial swelling will be assessed by measuring the distance (in millimeters) between the tragus and oral commissure, and between the tragus and pogonion using a standardized measuring tape.	posoperatively 3 days
Number of Participants with Alveolar Osteitis (Clinical Diagnosis)	Alveolar osteitis will be diagnosed clinically based on the presence of postoperative pain and exposed bone in the extraction socket.	post op 7 days
Mean Periodontal Probing Depth (mm) at Distal Surface of Mandibular Second Molar	Periodontal probing depth (in millimeters) will be measured at the distal aspect of the mandibular second molar using a periodontal probe.	post op 7 days
Mean Gingival Recession (mm) at Distal Surface of Mandibular Second Molar	Gingival recession (in millimeters) will be measured at the distal aspect of the mandibular second molar using a periodontal probe.	post op 7 days
Gingival Index Score (Löe and Silness Index, 0-3 Scale)	Gingival inflammation will be assessed using the Löe and Silness Gingival Index (0-3 scale), where higher scores indicate greater inflammation.	post op 7 days
Bleeding on Probing (Presence/Absence at Distal Surface of Second Molar)	Bleeding on probing will be assessed at the distal aspect of the mandibular second molar and recorded as present or absent.	postop 7 days

Collaborators and Investigators

• Sponsor: Gazi University
• Investigators: Principal Investigator: Nur Mollaoglu, OMFS PROFESSOR, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Gazi University, Ankara, Turkey; Study Director: Ahmet Talha OSMANOĞLU, OMFS RESİDENT, Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Gazi University, Ankara, Turkey

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Helpful Links

• Randomized controlled split-mouth trial on the effectiveness of platelet-rich fibrin after impacted mandibular third molar extraction.
• Randomized controlled split-mouth trial evaluating the effectiveness of absorbable collagen sponge after impacted mandibular third molar extraction.

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2025
• Primary Completion (Actual): November 30, 2025
• Study Completion (Actual): February 28, 2026

Study Registration Dates

• First Submitted: March 31, 2026
• First Submitted That Met QC Criteria: April 8, 2026
• First Posted (Actual): April 15, 2026

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Postoperative Pain; Wound Healing; Platelet-Rich Fibrin (PRF); Split-Mouth Design; Absorbable Collagen Sponge; Mandibular Third Molar Surgery; Alveolar Bone Healing
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Amino Acids, Peptides, and Proteins; Proteins; Blood Proteins; Fibrin; Fibrin Foam
• Other Study ID Numbers: M3-405030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No