Impact of Periodontal Treatment on NT-proBNP Levels
Primary Purpose
Periodontitis
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Evaluation of serum CRP and NT-proBNP
Sponsored by

About this trial
This is an interventional treatment trial for Periodontitis focused on measuring Periodontitis, serum markers, CRP, NT-proBNP
Eligibility Criteria
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
Sites / Locations
- University of Catania
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Full mouth non surgical periodontal treatment
Control
Arm Description
Each selected subject underwent to full mouth SRP.
Each selected subject underwent full mouth traditional oral hygiene.
Outcomes
Primary Outcome Measures
Change of Clinical Attachment Level
Change of periodontal Clinical Attachment Level
Secondary Outcome Measures
Full Information
NCT ID
NCT05174494
First Posted
December 13, 2021
Last Updated
January 27, 2023
Sponsor
University of Catania
1. Study Identification
Unique Protocol Identification Number
NCT05174494
Brief Title
Impact of Periodontal Treatment on NT-proBNP Levels
Official Title
Impact of Non Surgical Periodontal Treatment on Serum NT-proBNP Levels
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
January 2, 2020 (Actual)
Primary Completion Date
September 20, 2022 (Actual)
Study Completion Date
November 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Catania
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 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.
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
Keywords
Periodontitis, serum markers, CRP, NT-proBNP
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Each selected patient underwent randomly, without anaesthesia, after recording periodontal parameters, the two following treatments: in one, maxillary quadrants were treated as conventional Scaling and Root Planing (SRP), while the control group undergo to standard oral hygiene treatment.
Masking
ParticipantInvestigator
Masking Description
Though sealed envelopes both clinicians and patients were masked to the selected treatment
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Full mouth non surgical periodontal treatment
Arm Type
Active Comparator
Arm Description
Each selected subject underwent to full mouth SRP.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Each selected subject underwent full mouth traditional oral hygiene.
Intervention Type
Diagnostic Test
Intervention Name(s)
Evaluation of serum CRP and NT-proBNP
Intervention Description
All patients were evaluated to 6-months post-treatment reduction of serum CRP and NT-proBNP
Primary Outcome Measure Information:
Title
Change of Clinical Attachment Level
Description
Change of periodontal Clinical Attachment Level
Time Frame
6-months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gaetano Isola
Organizational Affiliation
University of Catania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Catania
City
Catania
State/Province
CT
ZIP/Postal Code
95124
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Publish study results and IDP sharing plan
IPD Sharing Time Frame
1-year
IPD Sharing Access Criteria
Pubmed
IPD Sharing URL
https://pubmed.ncbi.nlm.nih.gov/
Learn more about this trial
Impact of Periodontal Treatment on NT-proBNP Levels
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