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

NCT07047131 | Active Not Recruiting Phase 3

• 1 other identifier: 2301201902319
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Tooth Extraction; Bone Graft; Alveolar Bone Loss; Dental Implant

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to 5 years after implant loading

Secondary Outcomes (4)

• Number of participants with crown or implant failure

  From enrollment to 5 years after implant loading

• Number of biological and biomechanical complications

  From enrollment to 5 years after implant loading

• Peri-implant marginal bone level changes

  From enrollment to 5 years after implant loading

• Aesthetic evaluation using the Pink Esthetic Score (0-14; higher scores = better outcome)

  From enrollment to 5 years after implant loading

Study Arms (2)

Resorbable Bone Substitute (GTO®)

EXPERIMENTAL

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.

Biological: GTO® (fully resorbable bone substitute)

Partially Resorbable Bone Substitute (Apatos®)

ACTIVE COMPARATOR

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.

Biological: Apatos® (partially resorbable bone substitute)

Interventions

GTO® (fully resorbable bone substitute) BIOLOGICAL

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

Resorbable Bone Substitute (GTO®)

Apatos® (partially resorbable bone substitute) BIOLOGICAL

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

Partially Resorbable Bone Substitute (Apatos®)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marco Esposito: lead

Study Sites (1)

King Juan Carlos University

Madrid, Madrid, 28933, Spain

Location

Related Publications (4)

• Furhauser R, Florescu D, Benesch T, Haas R, Mailath G, Watzek G. Evaluation of soft tissue around single-tooth implant crowns: the pink esthetic score. Clin Oral Implants Res. 2005 Dec;16(6):639-44. doi: 10.1111/j.1600-0501.2005.01193.x.

  PMID: 16307569 BACKGROUND

• Thalmair T, Fickl S, Schneider D, Hinze M, Wachtel H. Dimensional alterations of extraction sites after different alveolar ridge preservation techniques - a volumetric study. J Clin Periodontol. 2013 Jul;40(7):721-7. doi: 10.1111/jcpe.12111. Epub 2013 May 5.

  PMID: 23647007 BACKGROUND

• De Angelis N, Felice P, Pellegrino G, Camurati A, Gambino P, Esposito M. Guided bone regeneration with and without a bone substitute at single post-extractive implants: 1-year post-loading results from a pragmatic multicentre randomised controlled trial. Eur J Oral Implantol. 2011 Winter;4(4):313-25.

  PMID: 22282729 BACKGROUND

• Esposito M, Grusovin MG, Polyzos IP, Felice P, Worthington HV. Interventions for replacing missing teeth: dental implants in fresh extraction sockets (immediate, immediate-delayed and delayed implants). Cochrane Database Syst Rev. 2010 Sep 8;2010(9):CD005968. doi: 10.1002/14651858.CD005968.pub3.

  PMID: 20824846 BACKGROUND

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Marco Esposito, Dentistry

  Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 2, 2025
• Study Start: December 18, 2018
• Primary Completion: December 20, 2025
• Study Completion (Estimated): December 20, 2030
• Last Updated: July 4, 2025

Record last verified: 2025-07

Locations

ES (1)