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NCT07879495

PHASE1/PHASE2

Alveolar Ridge Preservation (ARP) Study Using Alloplastic Biomaterial and a Resorbable Synthetic Membrane. A Digital Workflow (CBCT/Scanner) Evaluates Hard and Soft Tissue Volumetric Changes at 4 Months, Validating Support for the Gingival Phenotype and Buccal Bone Plate.

Sponsor: Universidad Católica San Antonio de Murcia

View on ClinicalTrials.gov

Summary

The dimensional collapse of the alveolar ridge following tooth extraction represents a critical challenge for implant rehabilitation. This research proposes an alveolar ridge preservation (ARP) protocol based on the combination of a slow-resorbing alloplastic synthetic biomaterial and a polymer-based resorbable synthetic membrane. Through a digital workflow integrating cone-beam computed tomography (CBCT) and intraoral scanning (Carestream 3800), volumetric changes in hard and soft tissues will be monitored. The study will compare baseline conditions with outcomes at 4 months of healing, analyzing whether the use of the membrane ensures adequate support for the gingival phenotype and minimizes buccal bone plate resorption.

Official title: EVALUACIÓN MEDIANTE FLUJO DIGITAL DEL IMPACTO DE LAS TERAPIAS DE PRESERVACIÓN ALVEOLAR EN LA ESTABILIDAD DIMENSIONAL DE LOS TEJIDOS

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-11

Completion Date

2028-10

Last Updated

2026-10-16

Healthy Volunteers

Conditions

Alveolar Ridge Augmentation Bone Substitutes Guided Tissue Regeneration, Periodontal Cone-Beam Computed Tomography Bone Resorption

Interventions

PROCEDURE

Alveolar Ridge Preservation using a synthetic alloplastic bone substitute and a resorbable polymer membrane

This experimental intervention is distinguished by a fully synthetic, animal-free grafting protocol. Following a strictly flapless tooth extraction to preserve periosteal blood supply to the buccal bundle bone, the socket is grafted with a slow-resorbing synthetic alloplastic bone substitute, designed to act as a long-term space maintainer rather than a rapidly turning-over material. Crucially, the graft is covered by a polymer-based resorbable synthetic membrane, distinguishing it from standard protocols utilizing native or cross-linked collagen. The membrane is stabilized using non-resorbable cross-mattress sutures. To prevent distortion of the mucogingival junction, no periosteal releasing incisions are performed, and the site is left to heal by secondary intention with the membrane intentionally left exposed to the oral environment

PROCEDURE

Minimally invasive flapless tooth extraction followed by unassisted spontaneous healing

This control intervention is strictly distinguished by the complete absence of any ridge preservation biomaterials. It represents the baseline dimensional collapse of the alveolar ridge. Following a minimally invasive, flapless tooth extraction identical to the experimental arm, the socket is vigorously debrided but left unassisted to heal via a natural blood clot. To distinguish this true negative control from active comparators, no hemostatic agents (e.g., oxidized regenerated cellulose or gelatin sponges) are placed within the alveolus. Sutures are applied strictly to stabilize the existing gingival margins and secure the coagulum, allowing physiological secondary intention healing without any artificial space maintenance

Inclusion Criteria: * Adult patients (\>18 years of age) with full cognitive capacity to understand and sign the Informed Consent approved by the UCAM Ethics Committee (in accordance with the 2022-23 Regulation). * Presence of at least one non-restorable mandibular premolar (first or second) or first mandibular molar with a clear indication for extraction and subsequent implant-supported prosthetic rehabilitation. * Buccal Bone Plate Integrity: Clinically intact buccal bone wall following baseline clinical examination and tomographic confirmation (T0 CBCT), presenting a continuous residual thickness of at least 1 mm, with no evidence of bone dehiscences or fenestrations prior to surgery (Type 1 sockets according to the Elian / Juodzbalys classification). * Absence of Active Infectious Processes: Surgical site free of signs of acute or exacerbated chronic infection. This excludes the presence of active suppuration, productive fistulas, periodontal abscesses, or extensive osteolytic periapical lesions (\>2 mm in radiographic diameter) that could alter tissue pH or destabilize the biomaterial. * Adequate or stabilized general periodontal health, defined by a Full-Mouth Plaque Score (FMPS) ≤ 20% and Full-Mouth Bleeding Score (FMBS) ≤ 20%. Exclusion Criteria: * Patients with uncontrolled systemic medical conditions that compromise bone or mucosal healing (e.g., Diabetes Mellitus with HbA1c \>7%, severe calcium metabolism disorders, severe hepatopathies, or nephropathies). * Patients undergoing active treatment with drugs that alter bone remodeling, such as systemic bisphosphonates (oral or intravenous), denosumab, or prolonged systemic corticosteroid therapies. * History of previous radiotherapy in the head and neck region, or active medical oncology. * Heavy smokers (\>10 cigarettes per day) due to the demonstrated deleterious impact of nicotine on angiogenesis and gingival collagen maturation, or substance abuse. * Pregnant or actively lactating women at the time of inclusion. * Any defect, intraoperative fracture, or unforeseen lesion detected in the buccal bone plate during the surgical extraction maneuver that compromises the baseline condition of alveolar wall integrity. * Patient inability to attend the rigorous follow-up appointments scheduled at 4 months, or severe claustrophobia preventing the acquisition of records via CBCT or intraoral scanning with the CS 3800.

Clinical Research Directory

Alveolar Ridge Preservation (ARP) Study Using Alloplastic Biomaterial and a Resorbable Synthetic Membrane. A Digital Workflow (CBCT/Scanner) Evaluates Hard and Soft Tissue Volumetric Changes at 4 Months, Validating Support for the Gingival Phenotype and Buccal Bone Plate.

Summary

Key Details

Conditions

Interventions

Eligibility Criteria