Impact of Periodontal Treatment on NT-proBNP Levels

Not Applicable

Completed

• Conditions: Periodontitis
• Interventions: Diagnostic Test: Evaluation of serum CRP and NT-proBNP

• Registration Number: NCT05174494
• Lead Sponsor: University of Catania

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)

Study Timeline

• Study Start: 2020-01-02
• Study First Submitted: 2021-12-13
• Study First Submitted QC: 2021-12-13
• Study First Posted: 2021-12-30
• Primary Completion: 2022-09-20
• Study Completion: 2022-11-30
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-27
• Last Update Posted: 2023-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Full mouth non surgical periodontal treatment	Evaluation of serum CRP and NT-proBNP	Each selected subject underwent to full mouth SRP.
Control	Evaluation of serum CRP and NT-proBNP	Each selected subject underwent full mouth traditional oral hygiene.

Primary Outcome Measures

Name	Time	Method
Change of Clinical Attachment Level	6-months	Change of periodontal Clinical Attachment Level

Trial Locations

Locations (1)

University of Catania; 🇮🇹 Catania, CT, Italy