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.

Browse trials for

• Bone Resorption 158

Bone Resorption

158 studies on the registry are indexed under Bone Resorption; 26 are open to participants now.

This study's planned enrollment of 28 is above the median of 24 across 137 interventional studies indexed under Bone Resorption.

Lead sponsor

Universidad Católica San Antonio de Murcia is the lead sponsor of 138 studies on the registry; 19 are open to participants now.

Study arms

• Experimental
  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.

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

• Other
  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.

  Procedure: Minimally invasive flapless tooth extraction followed by unassisted spontaneous healing

Interventions

• ProcedureAlveolar 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

• ProcedureMinimally 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

Primary outcomes

1. Absolute Volumetric Change of the Alveolar Ridge Contour

   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

   Time frame: Baseline (Day 0, immediately post-extraction) and at 4 months post-operative.

Individual participant data

Plan to share: Undecided