Effectiveness of Periodontal Therapy on Periodontal Bacteria

Periodontitis Clinical Trial

Official title:

Impact of Periodontal Bacteria on the Effectiveness of Periodontal Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04735692
• Other study ID #: 02318
• Status: Completed
• Phase: N/A
• Start date: February 5, 2021
• Est. completion date: December 5, 2022

Study information

• Verified date: December 2022
• 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 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: December 5, 2022
• Est. primary completion date: December 5, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Periodontitis

Intervention

Other:
• Full mouth or quadrant SRP
Full mouth or quadrant SRP

Locations

Country	Name	City	State
Italy	University of Catania	Catania	CT

Sponsors (1)

Lead Sponsor	Collaborator
University of Catania

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical attachment level	evaluation of changes in clinical attachment level	1-year