Impact of Periodontal Treatment on Growth Differentiation Factor-15 Levels

NCT ID: NCT05720481

Last Updated: 2023-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-20
• Study Completion Date: 2022-10-15

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

Conditions

Periodontal Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Periodontitis quadrant Scaling root planing (SRP)

Each selected subject underwent to quadrant SRP

Group Type: PLACEBO_COMPARATOR

Quadrant Scaling and root planing

Intervention Type: OTHER

patients were treated with quadrant Scaling and root planing

Periodontitis full mouth scaling root planing (SRP)

Each selected subject underwent to full mouth SRP

Group Type: ACTIVE_COMPARATOR

Full mouth Scaling and root planing

Intervention Type: OTHER

patients were treated with full mouth Scaling and root planing

Interventions

Full mouth Scaling and root planing

patients were treated with full mouth Scaling and root planing

Intervention Type: OTHER

Quadrant Scaling and root planing

patients were treated with quadrant Scaling and root planing

Intervention Type: OTHER

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Catania

OTHER

Sponsor Role: lead

Responsible Party

Gaetano Isola

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gaetano Isola

Role: PRINCIPAL_INVESTIGATOR

University of Catania

Locations

AOU Policlinico G. Rodolico

Catania, , Italy

Countries

Italy

References

Isola G, Tartaglia GM, Santonocito S, Chaurasia A, Marya A, Lo Giudice A. Growth differentiation factor-15 and circulating biomarkers as predictors of periodontal treatment effects in patients with periodontitis: a randomized-controlled clinical trial. BMC Oral Health. 2023 Aug 21;23(1):582. doi: 10.1186/s12903-023-03237-y.

Reference Type: DERIVED

PMID: 37605193 (View on PubMed)

Other Identifiers

PO-UniCt 125-2

Identifier Type: -

Identifier Source: org_study_id