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

Marco Esposito

Status and phase: Active, not recruiting; Phase 3

Conditions: Tooth Extraction; Alveolar Bone Loss; Dental Implant; Bone Graft

Treatments: Biological: GTO® (fully resorbable bone substitute); Biological: Apatos® (partially resorbable bone substitute)

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT07047131

2301201902319

Details and patient eligibility

About

This is a multicenter, double-blind randomized controlled trial evaluating two bone graft materials-one fully resorbable (GTO®) and one partially resorbable (Apatos®)-used during immediate post-extraction implant placement. The goal is to determine which material better preserves peri-implant bone volume and aesthetics over time.

Adult patients requiring a single-tooth extraction and immediate implant will be randomly assigned to receive either graft. Follow-up assessments will be conducted up to 5 years, including radiographic evaluation, implant stability, and aesthetic outcomes.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Any patient requiring at least one single immediate post-extractive implant.
• At least 18 year old, able to understand and to sign an informed consent
• There must be sufficient bone to allow the placement of at least a 3.5 mm diameter and 8.5 mm long implant.
• After tooth extraction there must be a potential gap of at least 2 mm from the buccal inner bone plate and the implant surface.

Exclusion criteria

• General contraindications to implant surgery.
• Immunosuppressed or immunocompromised patients.
• Patients irradiated in the head and/or neck.
• Uncontrolled diabetes.
• Pregnancy or lactation.
• Active periodontal disease
• Poor oral hygiene and motivation.
• Addiction to alcohol or drugs.
• Psychiatric problems and/or unrealistic expectations
• Patients with an acute infection (abscess) in the site intended for implant placement.
• Patients unable to commit to a 5-year follow-up.
• Patients treated or under treatment with intravenous amino-bisphosphonates.
• patients referred only for implant placement if follow-ups cannot be done at treatment centre.
• Patients participating in other studies, if the present protocol could not be fully adhered to. In case of doubts please contact the study coordinator.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Resorbable Bone Substitute (GTO®)

Experimental group

Description:

Patients receive a fully resorbable bone substitute (GTO®) to fill the gap between the implant and the buccal bone wall during immediate post-extraction implant placement.

Treatment:

Biological: GTO® (fully resorbable bone substitute)

Partially Resorbable Bone Substitute (Apatos®)

Active Comparator group

Description:

Patients receive a partially resorbable bone substitute (Apatos®) to fill the gap between the implant and the buccal bone wall during immediate post-extraction implant placement.

Treatment:

Biological: Apatos® (partially resorbable bone substitute)