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Effectiveness of Periodontal Therapy on Periodontal Bacteria

NCT ID: NCT04735692

Last Updated: 2022-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-05

Study Completion Date

2022-12-05

Brief Summary

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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

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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.

Conditions

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Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients undergo non-surgical quadrant scaling and root planing
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Both participants and clinicians were blinded to group and treatment assignment

Study Groups

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Periodontitis quadrant Scaling root planing

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

Group Type PLACEBO_COMPARATOR

Full mouth or quadrant SRP

Intervention Type OTHER

Full mouth or quadrant SRP

Periodontitis full mouth scaling root planing

Patients undergo non surgical full mouth scaling and root planing

Group Type ACTIVE_COMPARATOR

Full mouth or quadrant SRP

Intervention Type OTHER

Full mouth or quadrant SRP

Interventions

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Full mouth or quadrant SRP

Full mouth or quadrant SRP

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Catania

OTHER

Sponsor Role lead

Responsible Party

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Gaetano Isola

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gaetano Isola

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi di Catania

Locations

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University of Catania

Catania, CT, Italy

Site Status

Countries

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Italy

Other Identifiers

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02318

Identifier Type: -

Identifier Source: org_study_id