Impact of Periodontal Treatment on NT-proBNP Levels

University of Catania

Status: Completed

Conditions: Periodontitis

Treatments: Diagnostic Test: Evaluation of serum CRP and NT-proBNP

Study type: Interventional

Funder types: Other

Identifiers

NCT05174494

121/20/PO

Details and patient eligibility

About

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.

Full 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)

Enrollment: 33 patients

Sex: All

Ages: 35 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

33 participants in 2 patient groups, including a placebo group

Full mouth non surgical periodontal treatment

Active Comparator group

Description:

Each selected subject underwent to full mouth SRP.

Treatment:

Diagnostic Test: Evaluation of serum CRP and NT-proBNP

Control

Placebo Comparator group

Description:

Each selected subject underwent full mouth traditional oral hygiene.

Treatment:

Diagnostic Test: Evaluation of serum CRP and NT-proBNP