Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06398288
Status:
RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-04-27
Brief Title:
Adjunctive Use of Dermal Matrix to Compensate Dimensional Changes in the Reconstructive Therapy of Peri-implantitis
Sponsor:
Center of Implantology Oral and Maxillofacial Surgery Badajoz Spain
Organization:
Center of Implantology Oral and Maxillofacial Surgery Badajoz Spain
Study Overview
Official Title:
Adjunctive Use of Dermal Matrix to Compensate Dimensional Changes in the Reconstructive Therapy of Peri-implantitis Multi-Center Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-04
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:
One critical element regarded to successfully resolve peri-implantitis is to efficiently decontaminate 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 agentstrategy Recently the electrolytic approach has been indicated for the surgical detoxification in the management of peri-implantitis For the electrolytic approach EA the implant has to be loaded negatively with a voltage and a maximum current of 600 mA This is achieved by a device GS1000 GalvoSurge Dental AG Widnau Switzerland providing the voltage and pumping a sodium formiate solution through a spray-head which has to be pressed into the implant by finger pressure to achieve an electrical contact
Another critical aspect in the management of peri-implantitis is related to the esthetic sequelae associated with disease resolution Sanz-Martin et al in a systematic review demonstrated that reconstructive therapy is less prone to exhibit mucosal recession when compared to resective therapy Nonetheless it seems to be unavoidable no matter the surgical intervention Aiming at attenuating these changes Schwarz et al noted that the adjunctive use of connective tissue grafts may enhance the height of the mucosal level which in turn may impact upon the esthetic outcome Therefore the research question is the following What is the clinical radiographic and 3D volumetric effectiveness of dermal matrix to improve the outcome of reconstructive therapy of peri-implantitis-related bone defects The study is to be performed in two centers Center of Implantology Oral and Maxillofacial in Badajoz Spain and Clinical PerioCentrum Ortiz-Vigon in Bilbao Spain
Another critical aspect in the management of peri-implantitis is related to the esthetic sequelae associated with disease resolution Sanz-Martin et al in a systematic review demonstrated that reconstructive therapy is less prone to exhibit mucosal recession when compared to resective therapy Nonetheless it seems to be unavoidable no matter the surgical intervention Aiming at attenuating these changes Schwarz et al noted that the adjunctive use of connective tissue grafts may enhance the height of the mucosal level which in turn may impact upon the esthetic outcome Therefore the research question is the following What is the clinical radiographic and 3D volumetric effectiveness of dermal matrix to improve the outcome of reconstructive therapy of peri-implantitis-related bone defects The study is to be performed in two centers Center of Implantology Oral and Maxillofacial in Badajoz Spain and Clinical PerioCentrum Ortiz-Vigon in Bilbao Spain
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None