Tooth ExtractionBone GraftAlveolar Bone LossDental Implant
Investigational drug(s) / intervention(s)
GTO® (fully resorbable bone substitute)Apatos® (partially resorbable bone substitute)
GTO® (fully resorbable bone substitute): Collagenated heterologous cortico-cancellous porcine bone mix + thermogelling copolymer with collagen (GTO®, OsteoBiol®, Tecnoss®)
Apatos® (partially resorbable bone substitute): Porcine cortical bone granules (Apatos Cortical®, OsteoBiol®, Tecnoss®) stabilized with TSV Gel®, a thermogelling copolymer with collagen.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Changes in peri-implant bone volumes — From enrollment to 5 years after implant loading Volumetric changes in peri-implant tissues will be measured using limited-view CBCT scans taken at implant placement (baseline), 1 year, and 5 years after loading. The main endpoint is the difference in bone volume between baseline and 1 year.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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