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Evaluation of Metronidazole Hydrogel 25% in Stage II and III Periodontitis

NCT ID: NCT04983849

Last Updated: 2023-12-12

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

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-07

Study Completion Date

2021-07-07

Brief Summary

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A randomized clinical trial will be performed single-blind to evaluate the effectiveness of sublingual metronidazole hydrogel 25 % in periodontitis.

Detailed Description

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A randomized clinical trial will be performed single-blind to evaluate the effectiveness of sublingual metronidazole hydrogel 25 % in periodontitis in stage II and III.

At least 40 volunteers between the age of 18 and 80, will be enlisted, with the need to perform the SRP. In half of the mouth will be used the metronidazole hydrogel 25%, while in the other half no drugs will be used of delivered.

The study will be carried out in accordance with the Helsinki Declaration and the Protocol will be submitted to the Internal Review Board of the University to obtain authorization. Afterwards, the protocol will be recorded on the databa-se clinicaltrials.gov for clinical trials.

The protocol respects the SPIRIT parameters for the compilation of protocols on clinical trials and the study will respect the parameters of CONSORT sta-tement on randomized clinical trials.

Conditions

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Periodontitis

Keywords

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Periodontitis Periodontal disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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hydrogel metronidazole 25%

metronidazole hydrogel in adjunct to non surgical periodontal therapy

Group Type ACTIVE_COMPARATOR

metronidazole hydrogel

Intervention Type DRUG

scaling and root planning in adjunct to the use of metronidazole in the periodontal pocket

scaling and root planing

the only use of scaling and root planing

Group Type ACTIVE_COMPARATOR

scaling and root planning

Intervention Type PROCEDURE

scaling and root planning

Interventions

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metronidazole hydrogel

scaling and root planning in adjunct to the use of metronidazole in the periodontal pocket

Intervention Type DRUG

scaling and root planning

scaling and root planning

Intervention Type PROCEDURE

Other Intervention Names

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Non Surgical Periodontal Therapy

Eligibility Criteria

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Inclusion Criteria

* 10% of sites with survey depth 5 mm
* Comparable pockets in 4 mouth quadrants
* Health at systemic level

Exclusion Criteria

* Changes in oral mucosa
* Depth at the poll 5 mm
* Presence of removable prostheses or orthodontic equipment
* Allergies to even a single component of a product in testing• Antibiotic-based treatments during the 6 months preceding the start of testing
* History of previous periodontal treatments in the 12 months preceding the start of the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of L'Aquila

OTHER

Sponsor Role lead

Responsible Party

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Enrico Marchetti

Prof. Enrico Marchetti

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of L'Aquila, division of periodontology

L’Aquila, , Italy

Site Status

Countries

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Italy

Other Identifiers

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Prot. RCT 001/2021

Identifier Type: -

Identifier Source: org_study_id