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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-18

Study Completion Date

2030-12-20

Brief Summary

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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.

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Detailed Description

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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

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Tooth Extraction Bone Graft Alveolar Bone Loss Dental Implant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Resorbable Bone Substitute (GTO®)

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.

Group Type EXPERIMENTAL

GTO® (fully resorbable bone substitute)

Intervention Type BIOLOGICAL

Collagenated heterologous cortico-cancellous porcine bone mix + thermogelling copolymer with collagen (GTO®, OsteoBiol®, Tecnoss®)

Partially Resorbable Bone Substitute (Apatos®)

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.

Group Type ACTIVE_COMPARATOR

Apatos® (partially resorbable bone substitute)

Intervention Type BIOLOGICAL

Porcine cortical bone granules (Apatos Cortical®, OsteoBiol®, Tecnoss®) stabilized with TSV Gel®, a thermogelling copolymer with collagen.

Interventions

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GTO® (fully resorbable bone substitute)

Collagenated heterologous cortico-cancellous porcine bone mix + thermogelling copolymer with collagen (GTO®, OsteoBiol®, Tecnoss®)

Intervention Type BIOLOGICAL

Apatos® (partially resorbable bone substitute)

Porcine cortical bone granules (Apatos Cortical®, OsteoBiol®, Tecnoss®) stabilized with TSV Gel®, a thermogelling copolymer with collagen.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No