EVALUACIÓN MEDIANTE FLUJO DIGITAL DEL IMPACTO DE LAS TERAPIAS DE PRESERVACIÓN ALVEOLAR EN LA ESTABILIDAD DIMENSIONAL DE LOS TEJIDOS
Sponsor study identifier
interventional
28
0 countries
N/A
Study Start
November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
July 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 10, 2026
Actual (reported)October 16, 2026
Actual (reported)November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
July 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
October 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Baseline (Day 0, immediately post-extraction) and at 4 months post-operative.
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.
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 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
First Submitted
October 10, 2026
First Posted
October 16, 2026
Study Start
November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
July 2028
Adjunctive Use of Polynucleotide and Hyaluronic Acid-based Gel in Alveolar Preservation After Tooth Extraction
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
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Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 16, 2026
Record last verified: 2026-10
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