Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2026-01-02 @ 9:05 AM
Study NCT ID:
NCT05282667
Status:
COMPLETED
Last Update Posted:
2024-12-05
First Post:
2021-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reconstructive Management of Peri-implantitis
Sponsor:
Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
Organization:
Study Overview
Official Title:
Significance of Barrier Membrane in the Reconstructive Management of Peri-implantitis: A RCT
Status:
COMPLETED
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
With the growing burden of peri-implantitis around the globe, interest has flourished on the management of this pathology. Nevertheless, lack of consensus exists in the pursuit of a predictable therapy. Different therapeutic modalities have been advocated. Non-surgical therapy as a sole modality is often insufficient to resolve inflammation. Surgical interventions have demonstrated more favorable outcomes. Amongst these, evidence supported the application of resective, reconstructive, or combined approaches to limit progressive bone loss and achieve soft tissue health. Nevertheless, up to date, the most suitable modality remains unknown and the decision-making process derives from the understanding acquired from the management of periodontitis.
One critical element regarded to successfully resolve peri-implantitis is to efficiently detoxify the contaminated implant surface. Mechanical, pharmacological and chemical strategies have been proposed to eliminate bacterial plaque and remnants from the implant surface. However, evidence has not demonstrated superiority of a given detoxification agent/strategy.
In this sense, the significance of barrier membranes is not yet well understood. Roos-Jansaker in 2014 showed that the additional use of barrier membranes did not improve the outcome. Nevertheless, since then this subject has not been a matter of research.
One critical element regarded to successfully resolve peri-implantitis is to efficiently detoxify the contaminated implant surface. Mechanical, pharmacological and chemical strategies have been proposed to eliminate bacterial plaque and remnants from the implant surface. However, evidence has not demonstrated superiority of a given detoxification agent/strategy.
In this sense, the significance of barrier membranes is not yet well understood. Roos-Jansaker in 2014 showed that the additional use of barrier membranes did not improve the outcome. Nevertheless, since then this subject has not been a matter of research.
Detailed Description:
The effect of barrier membrane in the reconstructive management of peri-implantitis will be tested at 12-month follow-up
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: