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Impact of Periodontal Treatment on Growth Differentiation Factor-15 Levels

Primary Purpose

Periodontal Diseases

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Full mouth Scaling and root planing
Quadrant Scaling and root planing
Sponsored by
University of Catania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Diseases

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • AOU Policlinico G. Rodolico

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Periodontitis quadrant Scaling root planing (SRP)

Periodontitis full mouth scaling root planing (SRP)

Arm Description

Each selected subject underwent to quadrant SRP

Each selected subject underwent to full mouth SRP

Outcomes

Primary Outcome Measures

reduction of Growth differentiation factor-15 serum levels
evaluation of serum Growth differentiation factor-15 change

Secondary Outcome Measures

Full Information

First Posted
January 31, 2023
Last Updated
February 8, 2023
Sponsor
University of Catania
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1. Study Identification

Unique Protocol Identification Number
NCT05720481
Brief Title
Impact of Periodontal Treatment on Growth Differentiation Factor-15 Levels
Official Title
Impact of Non Surgical Periodontal Treatment on Growth Differentiation Factor-15 Levels
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
September 20, 2019 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
October 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Catania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Each selected patient underwent randomly, without anaesthesia, after recording periodontal parameters, the two following treatments: in one, maxillary quadrants were treated as conventional Quadrant Scaling and Root Planing (SRP) or Full-Mouth Scaling and Root Planing
Masking
ParticipantInvestigator
Masking Description
Sealed envelopes
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Periodontitis quadrant Scaling root planing (SRP)
Arm Type
Placebo Comparator
Arm Description
Each selected subject underwent to quadrant SRP
Arm Title
Periodontitis full mouth scaling root planing (SRP)
Arm Type
Active Comparator
Arm Description
Each selected subject underwent to full mouth SRP
Intervention Type
Other
Intervention Name(s)
Full mouth Scaling and root planing
Intervention Description
patients were treated with full mouth Scaling and root planing
Intervention Type
Other
Intervention Name(s)
Quadrant Scaling and root planing
Intervention Description
patients were treated with quadrant Scaling and root planing
Primary Outcome Measure Information:
Title
reduction of Growth differentiation factor-15 serum levels
Description
evaluation of serum Growth differentiation factor-15 change
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gaetano Isola
Organizational Affiliation
University of Catania
Official's Role
Principal Investigator
Facility Information:
Facility Name
AOU Policlinico G. Rodolico
City
Catania
ZIP/Postal Code
95124
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Study results
IPD Sharing Time Frame
6 months
IPD Sharing Access Criteria
Pubmed or internet

Learn more about this trial

Impact of Periodontal Treatment on Growth Differentiation Factor-15 Levels

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