NCT07530068

Adjacent Molar Outcomes After Third Molar Surgery With PRF or Collagen Sponge

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Gazi University · Academic / Other
• Sex: All
• Age: 18 Years – 30 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Impacted Mandibular Third Molar
• Wound Healing
• Postoperative Pain

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2025-02-28
• Primary completion: 2025-11-30
• Completion: 2026-02-28
• First posted: 2026-04-15
• Last updated: 2026-04-15

Locations

1 site across 1 country: Turkey (Türkiye)