Impact of Periodontal Treatment on NT-proBNP Levels

NCT05174494 | Completed

• 1 other identifier: 121/20/PO
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis

Keywords

Periodontitis; serum markers; CRP; NT-proBNP

Outcome Measures

Primary Outcomes (1)

• Change of Clinical Attachment Level

  Change of periodontal Clinical Attachment Level

  6-months

Study Arms (2)

Full mouth non surgical periodontal treatment

ACTIVE COMPARATOR

Each selected subject underwent to full mouth SRP.

Diagnostic Test: Evaluation of serum CRP and NT-proBNP

Control

PLACEBO COMPARATOR

Each selected subject underwent full mouth traditional oral hygiene.

Diagnostic Test: Evaluation of serum CRP and NT-proBNP

Interventions

Evaluation of serum CRP and NT-proBNP DIAGNOSTIC_TEST

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

Control; Full mouth non surgical periodontal treatment

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Catania: lead

Study Sites (1)

University of Catania

Catania, CT, 95124, Italy

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Gaetano Isola

  University of Catania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Though sealed envelopes both clinicians and patients were masked to the selected treatment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher, Dr.

Model Details: 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.

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: December 30, 2021
• Study Start: January 2, 2020
• Primary Completion: September 20, 2022
• Study Completion: November 30, 2022
• Last Updated: January 31, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 1-year
• Access Criteria: Pubmed

Locations

IT (1)