Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Gazi University, Ankara, Turkey
Ankara, 06490, Turkey (Türkiye)
NCT Number: NCT07530068
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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Notify Me18 year–30 year
All sexes
Interventional
Not applicable
Ankara, 06490, Turkey (Türkiye)
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
Gazi University
Other
Adjacent Molar Outcomes After Impacted Mandibular Third Molar Surgery With PRF or Collagen Sponge: A Randomized Split-Mouth Trial
Acronym: PRFvsCOLL-3M
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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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