Skip to main content
OpenTrials
Completed

NCT Number: NCT05720481

Impact of Periodontal Treatment on Growth Differentiation Factor-15 Levels

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AOU Policlinico G. Rodolico

Catania, 95124, Italy

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Full mouth Scaling and root planing

Other

patients were treated with full mouth Scaling and root planing

Quadrant Scaling and root planing

Other

patients were treated with quadrant Scaling and root planing

Primary outcomes

  1. reduction of Growth differentiation factor-15 serum levels

    Time frame: 6 months

    evaluation of serum Growth differentiation factor-15 change

Sponsors and collaborators

Lead sponsor

University of Catania

Other

Registry information

Official study title

Impact of Non Surgical Periodontal Treatment on Growth Differentiation Factor-15 Levels

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Feb 9, 2023
Registry last updated
Feb 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.