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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Gazi University, Ankara, Turkey | Ankara | Ankara | 06490 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32183831 | Result | 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. | |
| 39467892 | Result | 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. |
| Label | URL |
|---|---|
| Randomized controlled split-mouth trial on the effectiveness of platelet-rich fibrin after impacted mandibular third molar extraction. | View source |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D005339 | Fibrin Foam |
| ID | Term |
|---|---|
| D005337 | Fibrin |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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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.
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|
| 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. |
|
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| 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 |
| 22696337 | Result | 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. |
| 8233418 | Result | 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. |
| 15510357 | Result | 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. |
| Randomized controlled split-mouth trial evaluating the effectiveness of absorbable collagen sponge after impacted mandibular third molar extraction. | View source |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |