Impact of Periodontal Bacteria on the Effectiveness of Periodontal Therapy

University of Catania

Status: Completed

Conditions: Periodontitis

Treatments: Procedure: Scaling and root planing

Study type: Interventional

Funder types: Other

Identifiers

NCT05558293

20-2018-10

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 patients

Sex: All

Ages: 25 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

88 participants in 2 patient groups, including a placebo group

Periodontitis quadrant Scaling root planing

Placebo Comparator group

Description:

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

Treatment:

Procedure: Scaling and root planing

Periodontitis full mouth scaling root planing

Active Comparator group

Description:

Patients undergo non surgical full mouth scaling and root planing

Treatment:

Procedure: Scaling and root planing