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

Study Overview
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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.

Official Title
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Evaluation of Effects of Subgingival Administration of Metronidazole Hydrogel 25% in Stage II and III Periodontitis: Randomized, Split Mouth, Single-blind Trial.

Conditions
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Periodontitis

Intervention / Treatment
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* Drug: metronidazole hydrogel
* Procedure: scaling and root planning


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: hydrogel metronidazole 25%<br>metronidazole hydrogel in adjunct to non surgical periodontal therapy | Drug: metronidazole hydrogel<br>* scaling and root planning in adjunct to the use of metronidazole in the periodontal pocket<br>* Other names: Non Surgical Periodontal Therapy;|
| Active Comparator: scaling and root planing<br>the only use of scaling and root planing | Procedure: scaling and root planning<br>* scaling and root planning<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of MMP8 | matrix metalloproteinases (ng/ml) | baseline - 1 week | 
| Concentration of MMP9 | matrix metalloproteinases (ng/ml) | baseline - 1 week | 
| Concentration of IL1 | interleukin (pg/ml) | baseline - 1 week | 
| Concentration of IL6 | interleukin (pg/ml) | baseline - 1 week | 
| Concentration of IL8 | interleukin (pg/ml) | baseline - 1 week | 
| Concentration of IL17 | interleukin (pg/ml) | baseline - 1 week | 
| Concentration of TNF alfa | tumor necrosis factor alfa (pg/ml) | baseline - 1 week | 
| Concentration of RANK-L | Receptor activator of nuclear factor kappa-Β ligand (pg/ml) | baseline - 1 week | 
| Concentration of OPG | osteoprotegerin (pg/ml) | baseline - 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CAL | clinical attack level (mm) | baseline - 1 week | 
| PPD | Probing Pocket Depth (mm) | baseline - 1 week | 
| GI | gingival index (0-3) | baseline - 1 week | 
| FMPS | full mouth plaque score (0-100%) | baseline - 1 week | 
| FMBS | full mouth bleeding score (0-100%) | baseline - 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Periodontitis, Periodontal disease