Effectiveness of Periodontal Therapy on Periodontal Bacteria

NCT04735692 | Completed

• 1 other identifier: 02318
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (1)

• Clinical attachment level

  evaluation of changes in clinical attachment level

  1-year

Study Arms (2)

Periodontitis quadrant Scaling root planing

PLACEBO COMPARATOR

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

Other: Full mouth or quadrant SRP

Periodontitis full mouth scaling root planing

ACTIVE COMPARATOR

Patients undergo non surgical full mouth scaling and root planing

Other: Full mouth or quadrant SRP

Interventions

Full mouth or quadrant SRP OTHER

Full mouth or quadrant SRP

Periodontitis full mouth scaling root planing; Periodontitis quadrant Scaling root planing

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Catania: lead

Study Sites (1)

University of Catania

Catania, CT, 95124, Italy

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Gaetano Isola

  Università degli Studi di Catania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Both participants and clinicians were blinded to group and treatment assignment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Model Details: Patients undergo non-surgical quadrant scaling and root planing

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: February 3, 2021
• Study Start: February 5, 2021
• Primary Completion: December 5, 2022
• Study Completion: December 5, 2022
• Last Updated: December 16, 2022

Record last verified: 2022-12

Locations

IT (1)