Impact of Periodontal Treatment on NT-proBNP Levels

NCT ID: NCT05174494

Last Updated: 2023-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-02
• Study Completion Date: 2022-11-30

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)

Conditions

Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Full mouth non surgical periodontal treatment

Each selected subject underwent to full mouth SRP.

Group Type: ACTIVE_COMPARATOR

Evaluation of serum CRP and NT-proBNP

Intervention Type: DIAGNOSTIC_TEST

All patients were evaluated to 6-months post-treatment reduction of serum CRP and NT-proBNP

Control

Each selected subject underwent full mouth traditional oral hygiene.

Group Type: PLACEBO_COMPARATOR

Evaluation of serum CRP and NT-proBNP

Intervention Type: DIAGNOSTIC_TEST

All patients were evaluated to 6-months post-treatment reduction of serum CRP and NT-proBNP

Interventions

Evaluation of serum CRP and NT-proBNP

All patients were evaluated to 6-months post-treatment reduction of serum CRP and NT-proBNP

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Catania

OTHER

Sponsor Role: lead

Responsible Party

Gaetano Isola

Researcher, Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gaetano Isola

Role: PRINCIPAL_INVESTIGATOR

University of Catania

Locations

University of Catania

Catania, CT, Italy

Countries

Italy

Other Identifiers

121/20/PO

Identifier Type: -

Identifier Source: org_study_id