Impact of Periodontal Treatment on Growth Differentiation Factor-15 Levels

February 8, 2023 updated by: Gaetano Isola, University of Catania

Impact of Non Surgical 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Catania, Italy, 95124
        • AOU Policlinico G. Rodolico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Periodontitis quadrant Scaling root planing (SRP)
Each selected subject underwent to quadrant SRP
Other: Quadrant Scaling and root planing
patients were treated with quadrant Scaling and root planing
ACTIVE_COMPARATOR: Periodontitis full mouth scaling root planing (SRP)
Each selected subject underwent to full mouth SRP
Other: Full mouth Scaling and root planing
patients were treated with full mouth Scaling and root planing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
reduction of Growth differentiation factor-15 serum levels
Time Frame: 6 months
evaluation of serum Growth differentiation factor-15 change
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Catania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 20, 2019

Primary Completion (ACTUAL)

September 30, 2022

Study Completion (ACTUAL)

October 15, 2022

Study Registration Dates

First Submitted

January 31, 2023

First Submitted That Met QC Criteria

January 31, 2023

First Posted (ACTUAL)

February 9, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 13, 2023

Last Update Submitted That Met QC Criteria

February 8, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PO-UniCt 125-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study results

IPD Sharing Time Frame

6 months

IPD Sharing Access Criteria

Pubmed or internet

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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