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Clinical Trials/NCT06473545
NCT06473545CompletedNot Applicable

Retrospective Data Collection Evaluating the Performance of a Novel Biomimetic Synthetic Bone Substitute (Creos® Syntogain) up to 72 Months Follow-up

International dentistry Research Group2 sites in 1 country173 target enrollmentStarted: April 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
173
Locations
2
Primary Endpoint
Implant survival

Study Overview

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.

Detailed Description

  1. Title

Retrospective data collection evaluating the performance of a novel biomimetic synthetic bone substitute (Creos® Syntogain) up to 72 months follow-up. 2. Introduction

Edentulism, partial or full, can be predictably treated with esthetic and functional results with implant supported prosthesis when adequate alveolar bone is present. Jawbone defects or post-extraction edentulism atrophy of the alveolar bone need appropriate surgical techniques to preserve or augment the alveolar process. 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. However, successful clinical performance and results with the use SBG must be supported by scientific clinical evidence. 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. 3. Study hypothesis, aims and objectives

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 (SP) with a delayed implant placement (DIP), GBR simultaneous with immediate implant placement (IIP), and sinus lift elevation with lateral approach (SLE).

In order to test this hypothesis, the primary objective of this study is to retrospectively evaluate the clinical performance of a CE marked biomimetic SBG substitute (Creos® Syntogain, Nobel Biocare, Switzelrand) in patients with implant placement related bone regeneration treatments.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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.

Exclusion Criteria

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

Outcomes

Primary Outcomes

Implant survival

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

Implant in place at any follow up visit

Prosthesis survival

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

Prosthesis survival at any follow up visit

Secondary Outcomes

  • Peri-implant evaluation, soft tissue evaluation PES-WES score(From final prosthesis delivery through study completion, up to 72 months.)
  • Peri-implant evaluation, marginal bone loss(From final prosthesis delivery through study completion, up to 72 months.)
  • Complications(From initial surgical procedure date (GBR or implant placement) through study completion, up to 72 months)

Investigators

Sponsor
International dentistry Research Group
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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