Impact of Periodontal Bacteria on the Effectiveness of Periodontal Therapy

NCT ID: NCT05558293

Last Updated: 2023-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2022-12-05

Brief Summary

In light of the controversy that are already approved but that however still exists regarding the efficacy and influence of the protocols for the management of periodontitis, the aim of this study was to evaluate, at 6 months follow-up, the post-treatment clinical parameters and immunological and gingival microbial profiles in patients with periodontitis, treated by either SRP in addition to full mouth periodontal debridement.

Detailed Description

This trial was conducted in accordance with the World Medical Association's Declaration of Helsinki of 1975, and reviewed in 2008. Patients were enrolled from January 2020 to December 2022. The local ethical committee of approved the study protocol (125/PO) and each patient was carefully informed about the possible inherent risks of the study and provided their informed written consent 88 patients, aged 27 to 65 (mean age 57) were assessed for eligibility. In all subjects, subgingival plaque will acquired from 4 separate proximal periodontal sites.

Conditions

Periodontitis

Study Design

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

Study Groups

Periodontitis quadrant Scaling root planing

Patients undergo non surgical quadrant scaling and root planing performed per quadrant

Group Type: PLACEBO_COMPARATOR

Scaling and root planing

Intervention Type: PROCEDURE

Full mouth or quadrant SRP

Periodontitis full mouth scaling root planing

Patients undergo non surgical full mouth scaling and root planing

Group Type: ACTIVE_COMPARATOR

Scaling and root planing

Intervention Type: PROCEDURE

Full mouth or quadrant SRP

Interventions

Scaling and root planing

Full mouth or quadrant SRP

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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 a six teeth per quadrant, respectively.

Exclusion Criteria

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,

6. use of mouthwash containing antimicrobials during the previous 3 months,

7. no use of hormonal contraceptives,

8. medication by anti-inflammatory and immunosuppressive drugs,

9. previous history of hard-drinking,

10. smoking,

11. class II and III tooth mobility.

• Minimum Eligible Age: 25 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

Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gaetano Isola

Role: PRINCIPAL_INVESTIGATOR

University of Catania

Locations

University of Catania

Catania, CT, Italy

Countries

Italy

Other Identifiers

20-2018-10

Identifier Type: -

Identifier Source: org_study_id