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

University of L'Aquila40 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Periodontitis

Interventions

metronidazole hydrogelDRUG

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

scaling and root planningPROCEDURE

scaling and root planning

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of L'Aquila, division of periodontology

L’Aquila, Italy

Outcomes

Primary Outcomes

Concentration of MMP8

matrix metalloproteinases (ng/ml)

Time frame: baseline - 1 week

Concentration of MMP9

matrix metalloproteinases (ng/ml)

Time frame: baseline - 1 week

Concentration of IL1

interleukin (pg/ml)

Time frame: baseline - 1 week

Concentration of IL6

interleukin (pg/ml)

Time frame: baseline - 1 week

Concentration of IL8

interleukin (pg/ml)

Time frame: baseline - 1 week

Concentration of IL17

interleukin (pg/ml)

Time frame: baseline - 1 week

Concentration of TNF alfa

tumor necrosis factor alfa (pg/ml)

Time frame: baseline - 1 week

Concentration of RANK-L

Receptor activator of nuclear factor kappa-Β ligand (pg/ml)

Time frame: baseline - 1 week

Concentration of OPG

osteoprotegerin (pg/ml)

Time frame: baseline - 1 week

Secondary Outcomes

CAL

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.