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.
EVALUACIÓN MEDIANTE FLUJO DIGITAL DEL IMPACTO DE LAS TERAPIAS DE PRESERVACIÓN ALVEOLAR EN LA ESTABILIDAD DIMENSIONAL DE LOS TEJIDOS
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.
Aperçu de l'étude
Statut
Statut
Les conditions
Les conditions
Intervention / Traitement
Intervention / Traitement
Type d'étude
Type d'étude
Inscription (Estimé)
Inscription
Phase
Phase
- Phase 2
- La phase 1
Critères de participation
Critère d'éligibilité
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Nombre de bras
Armes et Interventions
Groupe de participants / BrasGroupe de participants / Bras |
Intervention / TraitementIntervention / Traitement |
|---|---|
|
Expérimental: Experimental: Alveolar Ridge Preservation (ARP) utilizing a Slow-Resorbing Synthetic Alloplast and a
Following atraumatic tooth extraction and rigorous socket debridement, the alveolar defect will be grafted with a slow-resorbing synthetic alloplastic bone substitute. A resorbable polymer-based synthetic barrier membrane will be adapted over the graft material. The surgical site will be managed via a [flapped / flapless] approach and stabilizing sutures will be placed to allow for [primary / secondary] intention healing. No loading or prosthetic provisionalization will be applied over the grafted socket during the 4-month healing period. |
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 |
|
Autre: No Intervention: Unassisted Spontaneous Healing (Natural Blood Clot)
Following atraumatic tooth extraction and rigorous socket debridement, the alveolar defect will be left to heal spontaneously without the application of any bone graft material or barrier membrane. A natural blood clot will be allowed to form and stabilize within the socket. The surgical site will be managed strictly via a flapless approach, with stabilizing sutures placed only if necessary to secure the coagulum and achieve hemostasis. The socket will undergo unassisted secondary intention healing during the 4-month observation period prior to implant placement evaluation. |
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 |
Que mesure l'étude ?
Principaux critères de jugement
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Absolute Volumetric Change of the Alveolar Ridge Contour
Délai: Baseline (Day 0, immediately post-extraction) and at 4 months post-operative.
|
The primary outcome is the total volumetric alteration of the alveolar ridge, encompassing combined hard and soft tissue dimensional changes. This will be quantified in cubic millimeters (mm^3) through a digital superimposition protocol. Baseline (Day 0) intraoral surface scans (STL) and Cone-Beam Computed Tomography (CBCT) DICOM files will be spatially aligned with 4-month (T1) postoperative STL and CBCT datasets using specialized image analysis software. A standardized Region of Interest (ROI) will be established using stable anatomical landmarks (e.g., adjacent teeth, hard palate) to calculate the absolute volume loss or gain |
Baseline (Day 0, immediately post-extraction) and at 4 months post-operative.
|
Collaborateurs et enquêteurs
Parrainer
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Début de l'étude
Achèvement primaire (Estimé)
Achèvement primaire
Achèvement de l'étude (Estimé)
Achèvement de l'étude
Dates d'inscription aux études
Première soumission
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Première publication
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour publiée
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
Autres numéros d'identification d'étude
- CE062612
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
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