Ignite Creation Date:
2024-05-06 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05720481
Status:
COMPLETED
Last Update Posted:
2023-02-13
First Post:
2023-01-31
Brief Title:
Impact of Periodontal Treatment on Growth Differentiation Factor-15 Levels
Sponsor:
University of Catania
Organization:
University of Catania
Study Overview
Official Title:
Impact of Non Surgical Periodontal Treatment on Growth Differentiation Factor-15 Levels
Status:
COMPLETED
Status Verified Date:
2023-02
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:
In light of the controversy that are already approved but that however still exists regarding the efficacy and influence the management of Periodontitis the aim of this study was to evaluates at 6-months follow-up the post-treatment clinical and serum parameters in patients with periodontitis treated by either Full Mouth Scaling and Root Planing FM-SRP treatment versus conventional oral hygiene treatment on serum CRP and Growth differentiation factor-15 levels
Detailed Description:
This trial was conducted in accordance with the World Medical Associations Declaration of Helsinki of 1975 and reviewed in 2016 The local ethical committee approved the study protocol and each patient was carefully informed about the possible inherent risks of the study and provided their informed written consent
Subjects with a diagnosis of periodontitis were enrolled in this clinical trial The inclusion criteria were 1 good condition of general health 2 a minimum of 2 teeth for each quadrant with a Pocket Depth PD ranging from 4-6 mm 3 no involvement of the furcation 4 a minimum of six teeth per quadrant respectively The exclusion criteria were 1 periodontal therapy during the last 12 months 2 assumption of antibiotics during the last 6 months 3 pregnancy 4 any systemic condition which might affect the effects of the study treatment 5 previous or current radiation or immunosuppressive therapies 5 use of mouthwash containing antimicrobials during the previous 3 months 6 no use of hormonal contraceptives 7 medication by anti-inflammatory and immunosuppressive drugs 8 previous history of hard-drinking 9 smoking 10 class II and III tooth mobility Patients randomly undergo to full mouth SRP or Quadrant SRP
Subjects with a diagnosis of periodontitis were enrolled in this clinical trial The inclusion criteria were 1 good condition of general health 2 a minimum of 2 teeth for each quadrant with a Pocket Depth PD ranging from 4-6 mm 3 no involvement of the furcation 4 a minimum of six teeth per quadrant respectively The exclusion criteria were 1 periodontal therapy during the last 12 months 2 assumption of antibiotics during the last 6 months 3 pregnancy 4 any systemic condition which might affect the effects of the study treatment 5 previous or current radiation or immunosuppressive therapies 5 use of mouthwash containing antimicrobials during the previous 3 months 6 no use of hormonal contraceptives 7 medication by anti-inflammatory and immunosuppressive drugs 8 previous history of hard-drinking 9 smoking 10 class II and III tooth mobility Patients randomly undergo to full mouth SRP or Quadrant SRP
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