Impact of Periodontal Bacteria on the Effectiveness of Periodontal Therapy

Periodontitis Clinical Trial

Official title:

Impact of Periodontal Bacteria on the Effectiveness of Periodontal Therapy Outcomes in Patients With Periodontitis: A Prospective Clinical and Microbial Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05558293
• Other study ID #: 20-2018-10
• Status: Completed
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: December 5, 2022

Study information

• Verified date: November 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 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.

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.

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: 25 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Periodontitis

Intervention

Procedure:
• Scaling and root planing
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	Probing depth changes	Measurment of Probing Depth changes in millimeters	6 months