Impacted Mandibular Third Molar, Wound Healing, Postoperative Pain
Conditions
Keywords
Platelet-Rich Fibrin (PRF), Absorbable Collagen Sponge, Mandibular Third Molar Surgery, Split-Mouth Design, Postoperative Pain, Wound Healing, Alveolar Bone Healing
Brief 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.
Interventions
BIOLOGICALAbsorbable 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.
BIOLOGICALPlatelet-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.
Sponsors
Gazi University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fractal Dimension and Lacunarity Values for Bone Healing | 12 weeks postoperatively | Radiographic bone healing in the extraction socket will be evaluated using fractal analysis and lacunarity measurements derived from standardized radiographs. |
| Postoperative Pain Score (Visual Analog Scale) | 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
| Measure | Time frame | Description |
|---|---|---|
| Facial Swelling Distance (Tragus-Commissure and Tragus-Pogonion Measurements in mm) | 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. |
| Number of Participants with Alveolar Osteitis (Clinical Diagnosis) | post op 7 days | Alveolar osteitis will be diagnosed clinically based on the presence of postoperative pain and exposed bone in the extraction socket. |
| Mean Periodontal Probing Depth (mm) at Distal Surface of Mandibular Second Molar | 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. |
| Mean Gingival Recession (mm) at Distal Surface of Mandibular Second Molar | post op 7 days | Gingival recession (in millimeters) will be measured at the distal aspect of the mandibular second molar using a periodontal probe. |
| Gingival Index Score (Löe and Silness Index, 0-3 Scale) | 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. |
| Bleeding on Probing (Presence/Absence at Distal Surface of Second Molar) | postop 7 days | Bleeding on probing will be assessed at the distal aspect of the mandibular second molar and recorded as present or absent. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORNur Mollaoglu, OMFS PROFESSOR
Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Gazi University, Ankara, Turkey
STUDY_DIRECTORAhmet Talha OSMANOĞLU, OMFS RESİDENT
Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Gazi University, Ankara, Turkey
Outcome results
None listed