NCT07047131

Resorbable vs Non-resorbable Bone Substitute at Immediate Post-extractive Single Implants

A Resorbable Versus a Non-resorbable Bone Substitute at Immediate Post-extractive Single Implants Immediately Loaded: a Multicentre Randomised Controlled Trial

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Marco Esposito · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study compares two bone graft materials used when placing a dental implant right after tooth removal. One graft fully dissolves (GTO®), the other only partly (Apatos®). The goal is to see which one better preserves bone and improves appearance around the implant.

Detailed description

This multicenter, double-blind randomized controlled trial aims to compare the clinical, radiographic, and aesthetic outcomes of two xenogeneic bone substitutes, GTO® (fully resorbable) and Apatos® (partially resorbable), used in post-extractive sockets at the time of immediate implant placement. Eligible patients are adults requiring a single-tooth extraction in the maxilla or mandible, followed by immediate implant placement. The primary outcome is peri-implant bone volume changes over time, assessed using CBCT scans. Secondary outcomes include implant and crown failure, implant stability, marginal bone level changes on periapical radiographs, and aesthetic outcomes evaluated using the pink esthetic score based on clinical photographs. Patients will be followed up to 5 years after loading.

Conditions

• Tooth Extraction
• Bone Graft
• Alveolar Bone Loss
• Dental Implant

Interventions

Type	Name	Description
BIOLOGICAL	GTO® (fully resorbable bone substitute)	Collagenated heterologous cortico-cancellous porcine bone mix + thermogelling copolymer with collagen (GTO®, OsteoBiol®, Tecnoss®)
BIOLOGICAL	Apatos® (partially resorbable bone substitute)	Porcine cortical bone granules (Apatos Cortical®, OsteoBiol®, Tecnoss®) stabilized with TSV Gel®, a thermogelling copolymer with collagen.

Timeline

• Start date: 2018-12-18
• Primary completion: 2025-12-20
• Completion: 2030-12-20
• First posted: 2025-07-02
• Last updated: 2025-07-04

Locations

1 site across 1 country: Spain