Retrospective Evaluation of a Novel Biomimetic Synthetic Bone Substitute (Creos® Syntogain)

NCT06473545 | Completed

• 1 other identifier: InDent_001
• Study Type: observational
• Target: 173
• Locations: 1 country
• Sites: 2

Brief Summary

Guided bone regeneration (GBR) is a commonly performed technique, using autogenous grafts, allografts, xenografts, or synthetic bone grafts (SBG). Advantages of an "off the shelf" substitute, available anytime with limitless fabrication capacity that avoids human, or animal associated morbidity provides SBG with a very positive future perspective. This data collection is to retrospectively evaluate the long-term clinical performance of a CE marked biomimetic SBG substitute in patients with implant placement related bone regeneration treatments up to 72 months of follow-up. The study hypothesis states that a biomimetic SBG is a verified graft choice to be used clinically in patients with implant placement related bone regeneration treatments such as socket preservation with a delayed implant placement, GBR simultaneous with immediate implant placement, and sinus lift elevation with lateral approach.

Conditions

Tooth Loss; Partial-edentulism; Tooth Fracture; Edentulous Alveolar Ridge

Keywords

Bone graft; Implant Placement; Immediate implant placement; Socket preservation; Guided bone regeneration; Synthetic bone graft; Delayed implant placement; Sinus elevation

Outcome Measures

Primary Outcomes (2)

• Implant survival

  Implant in place at any follow up visit

  From final prosthesis delivery through study completion, up to 72 months.

• Prosthesis survival

  Prosthesis survival at any follow up visit

  From final prosthesis delivery through study completion, up to 72 months.

Secondary Outcomes (3)

• Complications

  From initial surgical procedure date (GBR or implant placement) through study completion, up to 72 months

• Peri-implant evaluation, marginal bone loss

  From final prosthesis delivery through study completion, up to 72 months.

• Peri-implant evaluation, soft tissue evaluation PES-WES score

  From final prosthesis delivery through study completion, up to 72 months.

Study Arms (4)

Socket Preservation

Socket preservation is completed at the time of extraction. After removal of the tooth, the gum is elevated away from the bone, the socket is thoroughly cleansed, the socket is packed with the SBG and the wound closed. A healing time between 3 to 9 months is .

Immediate implant placement

Implant placement immediately after tooth extraction, the bone grafting material is packed between the implant and the bone wall.

Guided bone regeneration

When ridge augmentation is indicated, guided bone regeneration with the SBG and a barrier membrane are utilized at the time of tooth extraction or at an edentulous bone ridge. Either simultaneous implant placement or delayed implant placement are performed at the time of GBR surgery or after a 4 to 9 months healing time respectively.

Sinus elevation

Schneiderian membrane elevation to increase the residual crestal bone height in the posterior maxilla, bone grafting material is placed into the newly created space, including elevation through the lateral approach.

Eligibility Criteria

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

Study Population

Community population attending to one of the centers adhered to the study.

You may qualify if:

• The subject was at least 18 years of age (or age of consent) and has finalized skeletal growth at the time of surgery.
• Patient was in need of one or multiple tooth replacements.
• Treatment using synthetic bone graft was done for implant placement either in IIP or DIP.

You may not qualify if:

• Previous bone augmentation procedures with a different treatment choice (lateral or vertical regeneration).

Sponsors & Collaborators

• International dentistry Research Group: lead
• Nobel Biocare: collaborator

Study Sites (2)

Clínica Dental Altes Mesquida

Palma de Mallorca, Balearic Islands, 07004, Spain

Location

Cairó Franch Clinica Dental

Barbera Del Valles, Barcelona, 08210, Spain

Location

MeSH Terms

Conditions

Tooth Loss; Tooth Fractures

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases; Tooth Injuries; Wounds and Injuries

Study Officials

• Juan Mesquida, DDS

  International Dentistry Research Group Clinical Director

  PRINCIPAL INVESTIGATOR

• Ignacio Ginebreda, DDS

  International Dentistry Research Group co-Clinical Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 25, 2024
• Study Start: April 1, 2023
• Primary Completion: December 20, 2023
• Study Completion: December 20, 2023
• Last Updated: June 25, 2024

Record last verified: 2024-06

Locations

ES (2)