Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2026-02-20 @ 1:11 AM
Study NCT ID:
NCT04093895
Status:
COMPLETED
Last Update Posted:
2020-10-19
First Post:
2019-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial to Evaluate Safety, Tolerability, Efficacy of PerioSept® as Adjunct to SRP in Subjects With Periodontitis
Sponsor:
Geistlich Pharma AG
Organization:
Study Overview
Official Title:
A Phase 2 Trial to Evaluate the Safety, Tolerability and Efficacy of PerioSept® (3%) as Adjunct to Scaling and Root Planing in Subjects With Periodontitis
Status:
COMPLETED
Status Verified Date:
2020-10
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:
A Phase 2, uncontrolled, open-label, single arm study to evaluate the safety, tolerability and efficacy of PerioSept® (3%) as adjunct to Scaling and Root Planing in subjects with periodontitis.
Detailed Description:
Open-label, uncontrolled, single arm study to evaluate PerioSept® as adjunct to Scaling and Root Planing in Subjects with moderate to severe Periodontitis.
Up to 12 adult subjects will be enrolled to obtain at least 10 evaluable subjects.
4 study visits will take place for each enrolled subject (V1-V4 within 120 days). An additional optional follow-up visit (V5) at 6 Months might be added later on. On the baseline visit at Day 1 (V2) and if needed Day 2 (V2a) patients will undergo full mouth SRP followed by administration of PerioSept® 3% gel into gingival dental pockets. Treatment of PerioSept® 3% (without SRP) will be repeated at V3.
Eligible subjects must have a minimum of 4 qualifying target teeth defined as a tooth with at least one periodontal pocket with a probing pocket depth (PPD) \>= 6mm and bleeding on probing (BOP) at baseline defined as study pockets. All study pockets will be treated with SRP and PerioSept®. Additional teeth identified by investigator as needing SRP per standard of care but not meeting target teeth criteria will be defined as non-target teeth/treatment sites and may also be treated with SRP and PerioSept®.
Dental parameters will only be assessed on the target teeth and each of the 6 sites associated with these teeth (assessment sites). Thus, each eligible patient will have at least 4 Target teeth, a minimum of 4 study pockets and a minimum of 24 assessment sites (6 sites per tooth x 4 target teeth, inclusive of the 4 study pockets) that will be assessed for all study outcome measures.
Overall for all 10 evaluable patients there will be at least 40 target teeth, 40 study pockets and 240 sites for which the study outcome measures will be assessed as specified further below.
Assessments will be conducted over a 12 weeks' and optional 24 weeks' (3 and 6 months respectively) period including safety assessments, assessments of dental parameters (PPD, Clinical attachment level, BOP, recession, Plaque index, Gingival Index) and tolerability assessment.
Up to 12 adult subjects will be enrolled to obtain at least 10 evaluable subjects.
4 study visits will take place for each enrolled subject (V1-V4 within 120 days). An additional optional follow-up visit (V5) at 6 Months might be added later on. On the baseline visit at Day 1 (V2) and if needed Day 2 (V2a) patients will undergo full mouth SRP followed by administration of PerioSept® 3% gel into gingival dental pockets. Treatment of PerioSept® 3% (without SRP) will be repeated at V3.
Eligible subjects must have a minimum of 4 qualifying target teeth defined as a tooth with at least one periodontal pocket with a probing pocket depth (PPD) \>= 6mm and bleeding on probing (BOP) at baseline defined as study pockets. All study pockets will be treated with SRP and PerioSept®. Additional teeth identified by investigator as needing SRP per standard of care but not meeting target teeth criteria will be defined as non-target teeth/treatment sites and may also be treated with SRP and PerioSept®.
Dental parameters will only be assessed on the target teeth and each of the 6 sites associated with these teeth (assessment sites). Thus, each eligible patient will have at least 4 Target teeth, a minimum of 4 study pockets and a minimum of 24 assessment sites (6 sites per tooth x 4 target teeth, inclusive of the 4 study pockets) that will be assessed for all study outcome measures.
Overall for all 10 evaluable patients there will be at least 40 target teeth, 40 study pockets and 240 sites for which the study outcome measures will be assessed as specified further below.
Assessments will be conducted over a 12 weeks' and optional 24 weeks' (3 and 6 months respectively) period including safety assessments, assessments of dental parameters (PPD, Clinical attachment level, BOP, recession, Plaque index, Gingival Index) and tolerability assessment.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
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?: