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A Resorbable Versus a Non-resorbable Bone Substitute at Immediate Post-extractive Single Implants Immediately Loaded: a Multicentre Randomised Controlled Trial
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
King Juan Carlos University
Madrid, Madrid, Spain
Start Date
December 18, 2018
Primary Completion Date
December 20, 2025
Completion Date
December 20, 2030
Last Updated
July 4, 2025
50
ESTIMATED participants
GTO® (fully resorbable bone substitute)
BIOLOGICAL
Apatos® (partially resorbable bone substitute)
BIOLOGICAL
Lead Sponsor
Marco Esposito
NCT07434505
NCT06275789
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06975306