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

Phase 3Active Not RecruitingNCT07047131

Marco Esposito50 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Tooth Extraction Bone Graft Alveolar Bone Loss Dental Implant

Interventions

GTO® (fully resorbable bone substitute)BIOLOGICAL

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

Apatos® (partially resorbable bone substitute)BIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

King Juan Carlos University

Madrid, Madrid, Spain

Outcomes

Primary Outcomes

Changes in peri-implant bone volumes

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.

Time frame: From enrollment to 5 years after implant loading

Secondary Outcomes

Number of participants with crown or implant failure

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.

Time frame: From enrollment to 5 years after implant loading

Number of biological and biomechanical complications

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.

Time frame: From enrollment to 5 years after implant loading

Peri-implant marginal bone level changes

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.

Data from ClinicalTrials.gov

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