Overview
The goal of this clinical trial is to compare the effectiveness of four post-extraction socket management approaches in preserving alveolar ridge dimensions following tooth extraction in adults requiring implant-supported rehabilitation in posterior regions.
The main questions it aims to answer are:
- Which treatment approach provides the greatest preservation of hard- and soft-tissue dimensions 12 weeks after tooth extraction?
- Does the use of a dense polytetrafluoroethylene (d-PTFE) membrane improve alveolar ridge preservation compared with approaches that do not use a membrane?
- Are there differences among the treatment groups regarding postoperative healing, complications, pain, and bone regeneration?
Researchers will compare spontaneous socket healing, autologous blood clot with d-PTFE membrane, autologous blood clot with leukocyte- and platelet-rich fibrin (L-PRF), and autologous blood clot with L-PRF plus d-PTFE membrane to determine which approach provides the best preservation of alveolar ridge dimensions and tissue healing.
Participants will:
- Undergo tooth extraction and be randomly assigned to one of four treatment groups.
- Receive clinical examinations, intraoral scans, photographs, and cone-beam computed tomography (CBCT) imaging at scheduled follow-up visits.
- Complete assessments of postoperative pain and oral health-related quality of life.
- Undergo implant placement 12 weeks after tooth extraction, including collection of a bone biopsy for histomorphometric analysis.
- Attend follow-up visits to evaluate peri-implant tissue health, marginal bone stability, and implant success up to 24 months after implant loading.
Description
Alveolar ridge dimensional changes following tooth extraction are a well-documented biological phenomenon that may compromise future implant placement and prosthetic rehabilitation. These alterations are primarily associated with physiological bone modeling and remodeling processes, particularly affecting the buccal bone plate, which is often thin and highly susceptible to post-extraction resorption.
Alveolar ridge preservation (ARP) procedures have been developed to reduce post-extraction hard- and soft-tissue volume loss. Numerous techniques have been described, including the use of barrier membranes, platelet concentrates, and grafting materials. However, substantial controversy remains regarding the necessity of membrane utilization, the role of leukocyte- and platelet-rich fibrin (L-PRF), and the optimal approach for maintaining alveolar ridge dimensions while minimizing treatment complexity and costs.
Dense polytetrafluoroethylene (d-PTFE) membranes have been proposed as an effective barrier for preserving extraction socket architecture, whereas L-PRF has been suggested to enhance soft-tissue healing and tissue regeneration through the release of autologous growth factors. Despite the widespread clinical use of both approaches, evidence comparing these treatment strategies remains limited.
This randomized controlled clinical trial aims to compare four post-extraction socket management protocols: spontaneous healing, autologous blood clot combined with a d-PTFE membrane, autologous blood clot combined with L-PRF, and autologous blood clot combined with both L-PRF and a d-PTFE membrane. The study will evaluate their effects on hard- and soft-tissue dimensional preservation, clinical healing, postoperative outcomes, histomorphometric bone formation, patient-reported quality of life, and long-term implant-related outcomes.
The findings of this study are expected to contribute to the development of evidence-based protocols for alveolar ridge preservation and to improve clinical decision-making in implant dentistry.
Eligibility
Inclusion Criteria:
- Adults aged 18 years or older.
- Requirement for tooth extraction with the possibility of subsequent implant-supported rehabilitation in the maxillary or mandibular premolar or molar regions.
- Extraction sockets classified as Class I to Class Va according to the modified Cardaropoli classification.
- American Society of Anesthesiologists (ASA) Physical Status I or II.
- Ability to understand the study procedures and provide written informed consent.
Exclusion Criteria:
- Current treatment with bisphosphonates or systemic corticosteroids.
- History of head and neck radiotherapy.
- Metabolic bone disorders.
- Teeth presenting with acute infectious pathology at the time of extraction.
- Pregnancy or breastfeeding.
- Inability or unwillingness to attend scheduled follow-up visits.
- Any medical or psychological condition that, in the opinion of the investigators, could interfere with study participation or data interpretation.
