About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Spontaneous Healing
Procedure/SurgeryFollowing atraumatic tooth extraction, the extraction socket is left to heal naturally without the use of alveolar ridge preservation materials, grafting biomaterials, platelet concentrates, or barrier membranes. Healing occurs through spontaneous blood clot formation and physiological post-extraction tissue repair.
d-PTFE Membrane
Procedure/SurgeryFollowing atraumatic tooth extraction, the socket is allowed to fill with an autologous blood clot and is covered with a dense polytetrafluoroethylene (d-PTFE) membrane to protect the socket and support alveolar ridge preservation during healing
Leukocyte- and Platelet-Rich Fibrin (L-PRF)
Procedure/SurgeryAutologous leukocyte- and platelet-rich fibrin (L-PRF) prepared from the participant's peripheral blood and placed within the extraction socket to promote tissue healing and support alveolar ridge preservation through the sustained release of growth factors.
Treatment groups
Trial outcomes
Primary outcomes
Change in Alveolar Ridge Dimensions
Change in hard- and soft-tissue dimensions of the extraction site between baseline (T1) and 12 weeks after tooth extraction (T3), assessed through three-dimensional volumetric analysis using superimposed CBCT and intraoral scan datasets. Hard-tissue measurements include horizontal ridge width at 1, 3, and 5 mm apical to the alveolar crest (HW-1, HW-3, HW-5), buccal plate width, and socket depth. Soft-tissue measurements include tissue thickness at 1, 3, and 5 mm apical to the alveolar crest (TH-1, TH-3, TH-5) and total occlusal soft-tissue height.
Secondary outcomes
Histomorphometric Bone Formation
Percentage of newly formed bone, residual biomaterial, and connective tissue/marrow spaces measured in bone biopsy specimens obtained during implant placement.
Postoperative Pain
Patient-reported postoperative pain assessed using a 100-mm Visual Analogue Scale (VAS).
Postoperative Complications
Frequency and severity of soft-tissue dehiscence, membrane exposure or displacement, localized infection, and uncontrolled acute pain.
Keratinized Tissue Width
Change in the width of keratinized tissue measured clinically in millimeters.
Sponsors and contacts
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