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

University of L'Aquila

Status and phase

Completed

Phase 4

Conditions

Periodontitis

Treatments

Drug: metronidazole hydrogel

Procedure: scaling and root planning

Study type

Interventional

Funder types

Other

Identifiers

NCT04983849

Prot. RCT 001/2021

Details and patient eligibility

About

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

Full description

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.

Enrollment

40 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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