Effectiveness of Periodontal Therapy on Periodontal Bacteria

Not Applicable

Completed

• Conditions: Periodontitis
• Interventions: Other: Full mouth or quadrant SRP

• Registration Number: NCT04735692
• Lead Sponsor: University of Catania

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 scaling or quadrant scaling

Detailed Description

This trial was conducted in accordance with the World Medical Association's Declaration of Helsinki of 1975, and reviewed in 2008. The local ethical committee of the University of Messina approved the study protocol 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 was acquired from 4 separate proximal sites at 180 days after therapy.

Study Timeline

• Study First Submitted: 2021-01-29
• Study First Submitted QC: 2021-01-29
• Study First Posted: 2021-02-03
• Study Start: 2021-02-05
• Status Verified: 2022-12
• Primary Completion: 2022-12-05
• Study Completion: 2022-12-05
• Last Update Submitted: 2022-12-13
• Last Update Posted: 2022-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

• Presence of at least 15 teeth

• CP with a minimum of 40% of sites with a clinical attachment level (CAL)

  ≥2mm and probing depth (PD) ≥4mm;

• Presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs

• Presence of ≥40% sites with bleeding on probing (BOP)

Exclusion Criteria

• Intake of contraceptives
• Intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study
• Status of pregnancy or lactation
• Previous history of excessive drinking
• Allergy to local anaesthetic
• Intake of drugs that may potentially determine gingival hyperplasia such as Hydantoin, Nifedipine, Cyclosporin A or similar drugs.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Periodontitis quadrant Scaling root planing	Full mouth or quadrant SRP	Patients undergo non surgical quadrant scaling and root planing performed per quadrant
Periodontitis full mouth scaling root planing	Full mouth or quadrant SRP	Patients undergo non surgical full mouth scaling and root planing

Primary Outcome Measures

Name	Time	Method
Clinical attachment level	1-year	evaluation of changes in clinical attachment level

Trial Locations

Locations (1)

University of Catania; 🇮🇹 Catania, CT, Italy