- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05174494
Impact of Periodontal Treatment on NT-proBNP Levels
Impact of Non Surgical Periodontal Treatment on Serum NT-proBNP Levels
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 Intensive scaling and root planing (SRP) treatment versus conventional oral hygiene treatment on serum CRP and NT-proBNP levels.
The null hypothesis to invalidate was that there were no variations, in relation to clinical and serum CRP and NT-proBNP.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This trial was conducted in accordance with the World Medical Association's 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 a 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 (test group) or oral hygiene treatment (control group)
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
CT
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Catania, CT, Italy, 95124
- University of Catania
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- good condition of general health
- a minimum of 2 teeth for each quadrant with
- Pocket Depth (PD) ranging from 4-6 mm
- no involvement of the furcation
- a minimum of a six teeth per quadrant, respectively
Exclusion Criteria:
- periodontal therapy during the last 12 months
- assumption of antibiotics during the last 6 months
- pregnancy
- any systemic condition which might affect the effects of the study treatment
- previous or current radiation or immunosuppressive therapies
- use of mouthwash containing antimicrobials during the previous 3 months
- no use of hormonal contraceptives
- medication by anti-inflammatory and immunosuppressive drugs
- previous history of hard drinking
- smoking
- class II and III tooth mobility
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Full mouth non surgical periodontal treatment
Each selected subject underwent to full mouth SRP.
|
All patients were evaluated to 6-months post-treatment reduction of serum CRP and NT-proBNP
|
Placebo Comparator: Control
Each selected subject underwent full mouth traditional oral hygiene.
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All patients were evaluated to 6-months post-treatment reduction of serum CRP and NT-proBNP
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of Clinical Attachment Level
Time Frame: 6-months
|
Change of periodontal Clinical Attachment Level
|
6-months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 121/20/PO
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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