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Completed

NCT Number: NCT07530068

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

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.

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Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Ankara, 06490, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Absorbable Collagen Sponge

Biological

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

Primary outcomes

  1. Fractal Dimension and Lacunarity Values for Bone Healing

    Time frame: 12 weeks postoperatively

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

  2. Postoperative Pain Score (Visual Analog Scale)

    Time frame: 3 days postoperatively

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

Secondary outcomes

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

    Time frame: posoperatively 3 days

    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.

  2. Number of Participants with Alveolar Osteitis (Clinical Diagnosis)

    Time frame: post op 7 days

    Alveolar osteitis will be diagnosed clinically based on the presence of postoperative pain and exposed bone in the extraction socket.

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

    Time frame: post op 7 days

    Periodontal probing depth (in millimeters) will be measured at the distal aspect of the mandibular second molar using a periodontal probe.

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

    Time frame: post op 7 days

    Gingival recession (in millimeters) will be measured at the distal aspect of the mandibular second molar using a periodontal probe.

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

    Time frame: post op 7 days

    Gingival inflammation will be assessed using the Löe and Silness Gingival Index (0-3 scale), where higher scores indicate greater inflammation.

  6. Bleeding on Probing (Presence/Absence at Distal Surface of Second Molar)

    Time frame: postop 7 days

    Bleeding on probing will be assessed at the distal aspect of the mandibular second molar and recorded as present or absent.

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

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

Acronym: PRFvsCOLL-3M

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Apr 15, 2026
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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