Impact of Periodontal Treatment on NT-proBNP Levels

Periodontitis Clinical Trial

Official title:

Impact of Non Surgical Periodontal Treatment on Serum NT-proBNP Levels

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05174494
• Other study ID #: 121/20/PO
• Status: Completed
• Phase: N/A
• Start date: January 2, 2020
• Est. completion date: November 30, 2022

Study information

• Verified date: January 2023
• Source: University of Catania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: November 30, 2022
• Est. primary completion date: September 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Periodontitis

Intervention

Diagnostic Test:
• Evaluation of serum CRP and NT-proBNP
All patients were evaluated to 6-months post-treatment reduction of serum CRP and NT-proBNP

Locations

Country	Name	City	State
Italy	University of Catania	Catania	CT

Sponsors (1)

Lead Sponsor	Collaborator
University of Catania

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Clinical Attachment Level	Change of periodontal Clinical Attachment Level	6-months