Impact of Periodontal Treatment on Growth Differentiation Factor-15 Levels

Periodontal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05720481
• Other study ID #: PO-UniCt 125-2
• Status: Completed
• Phase: N/A
• Start date: September 20, 2019
• Est. completion date: October 15, 2022

Study information

• Verified date: February 2023
• Source: University of Catania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: October 15, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Periodontal Diseases

Intervention

Other:
• Full mouth Scaling and root planing
patients were treated with full mouth Scaling and root planing
• Quadrant Scaling and root planing
patients were treated with quadrant Scaling and root planing

Locations

Country	Name	City	State
Italy	AOU Policlinico G. Rodolico	Catania

Sponsors (1)

Lead Sponsor	Collaborator
University of Catania

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reduction of Growth differentiation factor-15 serum levels	evaluation of serum Growth differentiation factor-15 change	6 months