Impact of Periodontal Treatment on Growth Differentiation Factor-15 Levels

Not Applicable

Completed

• Conditions: Periodontal Diseases
• Interventions: Other: Full mouth Scaling and root planing; Other: Quadrant Scaling and root planing

• Registration Number: NCT05720481
• 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 Full Mouth Scaling and Root Planing (FM-SRP) treatment versus conventional oral hygiene treatment on serum CRP and Growth differentiation factor-15 levels.

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 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 or Quadrant SRP

Study Timeline

• Study Start: 2019-09-20
• Primary Completion: 2022-09-30
• Study Completion: 2022-10-15
• Study First Submitted: 2023-01-31
• Study First Submitted QC: 2023-01-31
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-08
• Study First Posted: 2023-02-09
• Last Update Posted: 2023-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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
Periodontitis full mouth scaling root planing (SRP)	Full mouth Scaling and root planing	Each selected subject underwent to full mouth SRP
Periodontitis quadrant Scaling root planing (SRP)	Quadrant Scaling and root planing	Each selected subject underwent to quadrant SRP

Primary Outcome Measures

Name	Time	Method
reduction of Growth differentiation factor-15 serum levels	6 months	evaluation of serum Growth differentiation factor-15 change

Trial Locations

Locations (1)

AOU Policlinico G. Rodolico; 🇮🇹 Catania, Italy