Ignite Creation Date:
2024-05-06 @ 7:20 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05975177
Status:
COMPLETED
Last Update Posted:
2023-08-07
First Post:
2023-07-26
Brief Title:
Evaluation of the Efficacy of STERIFY GEL in the Treatment of Periodontitis Following Scaling and Root Planing
Sponsor:
Sterify Srl
Organization:
Sterify Srl
Study Overview
Official Title:
Evaluation of the Efficacy and Safety of STERIFY GEL in the Treatment of Periodontitis Following Scaling and Root Planing Pivotal Prospective Single-center Split-mouth Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2023-08
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:
SFYCT
Brief Summary:
The purpose of this clinical study is to evaluate the safety and efficacy of treating periodontal disease with the STERIFY GEL medical device in combination with SRP procedure in terms of periodontal pocket healing Efficacy will be compared with the use of the nonsurgical SRP technique alone which is considered a gold standard treatment for periodontitis with the aim of observing improved results when using the STERIFY GEL device
The study is prospective split-mouthSTERIFY GEL will be administered into the periodontal pockets of one or two segments of patients undergoing whole-mouth extended SRP with the contralateral segments serving as controls split-mouth in a single session
The study is prospective split-mouthSTERIFY GEL will be administered into the periodontal pockets of one or two segments of patients undergoing whole-mouth extended SRP with the contralateral segments serving as controls split-mouth in a single session
Detailed Description:
The purpose of the study is to test the safety and efficacy of STERIFY GEL in promoting healing of periodontal pockets following SRP compared with treatment with SRP alone With specific visco-elastic and mucoadhesive properties STERIFY GEL easily penetrates into the deepest and hard-to-reach areas of periodontal and peri-implant pockets adhering to the gingival tissue and alveolar bone providing complete coverage of the pockets The effect of STERIFY GEL is promoted by a physical mechanism of action After SRP the gel is applied into the gingival pocket where it acts primarily as a filler to restore volume physically preventing bacteria from entering and reinfecting the pocket STERIFY GEL can thus mechanically protect treated pockets and bone defects promoting tissue healing The occluding action at the level of periodontal and peri-implant gingival pockets in synergy with the accessory action of hydroxytyrosol nisin and magnesium ascorbyl phosphate prevents bacterial recolonization and promotes subsequent tissue regeneration
Although SRP surgery is considered a gold standard treatment for periodontitis it may in some cases be insufficient to decontaminate the pocket allowing bacteria to recolonize the tissues promoting new inflammation that can worsen the clinical pictureSTERIFY GEL may find useful application in cases of moderate to severe chronic periodontal disease as an adjunctive treatment following SRP to improve and accelerate healing parameters and prevent recurrent inflammation and infectionIn addition antimicrobial control action prevents antibiotic use and the risk associated with antibiotic resistanceSuch control of periodontal disease also allows for the maintenance of patients who cannot undergo surgical treatment eg patients on bisphosphonate therapy defected etc
Although SRP surgery is considered a gold standard treatment for periodontitis it may in some cases be insufficient to decontaminate the pocket allowing bacteria to recolonize the tissues promoting new inflammation that can worsen the clinical pictureSTERIFY GEL may find useful application in cases of moderate to severe chronic periodontal disease as an adjunctive treatment following SRP to improve and accelerate healing parameters and prevent recurrent inflammation and infectionIn addition antimicrobial control action prevents antibiotic use and the risk associated with antibiotic resistanceSuch control of periodontal disease also allows for the maintenance of patients who cannot undergo surgical treatment eg patients on bisphosphonate therapy defected etc
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