Alveolar Bone Loss, Bone Graft, Dental Implant, Tooth Extraction
Conditions
Brief 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.
Interventions
BIOLOGICALGTO® (fully resorbable bone substitute)
Collagenated heterologous cortico-cancellous porcine bone mix + thermogelling copolymer with collagen (GTO®, OsteoBiol®, Tecnoss®)
BIOLOGICALApatos® (partially resorbable bone substitute)
Porcine cortical bone granules (Apatos Cortical®, OsteoBiol®, Tecnoss®) stabilized with TSV Gel®, a thermogelling copolymer with collagen.
Sponsors
Marco Esposito
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with crown or implant failure | From enrollment to 5 years after implant loading | Defined as the inability to place the crown due to implant failure, or the need for crown replacement for any reason. Implant failure is defined as implant mobility and/or any infection dictating implant removal and any mechanical complications rendering the implant unusable (e.g. implant fracture). The stability of each individual implant will be measured by the blinded outcome assessor manually by assessing the stability of the crown using the handles of two metallic instruments at 1 and 5 years after loading. |
| Number of biological and biomechanical complications | From enrollment to 5 years after implant loading | Biological and biomechanical complications will be recorded and reported by study group. Examples of biological complications are: fistula, peri-implantitis. Examples of biomechanical complications are fracture of the metal screws, loosening of the crown, fracture of the ceramic lining. |
| Peri-implant marginal bone level changes | From enrollment to 5 years after implant loading | Periapical digital radiographs will be made with the paralleling technique at implant placement, at 1 and 5 years of loading. In case of an unreadable radiograph, the radiograph must be made again. Peri-implant marginal bone levels will be measured using the Image J (National Institutes of Health, Bethesda, Maryland, USA) software. The software will be calibrated for every single image using the known implant length or, if the full implants is not visible on the radiograph, the implant diameter. Measurements of the mesial and distal bone crest level adjacent to each implant will be made to the nearest 0.01 mm. Reference points for the linear measurements will be: the coronal margin of the implant collar and the most coronal point of bone-to-implant contact. Bone levels will be measured at both mesial and distal sides and averaged. Bone level at single implants will be averaged at group level. |
| Aesthetic evaluation using the Pink Esthetic Score (0-14; higher scores = better outcome) | From enrollment to 5 years after implant loading | Aesthetic evaluation of the clinical pictures taken at delivery of the final crown (baseline), at 1- and 5-year follow-ups, on a computer screen by an independent blinded dentist. The pictures of the vestibular and occlusal aspects must include the two adjacent teeth. The aesthetic evaluation will be done following thePink Esthetic Score, a validated index that ranges from 0 (worst aesthetic outcome) to 14 (best aesthetic outcome), based on soft tissue parameters around the implant implant-supported crown. |
Countries
Spain
Outcome results
None listed