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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hydrogel metronidazole 25% | Active Comparator | metronidazole hydrogel in adjunct to non surgical periodontal therapy |
|
| scaling and root planing | Active Comparator | the only use of scaling and root planing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| metronidazole hydrogel | Drug | scaling and root planning in adjunct to the use of metronidazole in the periodontal pocket |
|
| 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-Î’ ligand (pg/ml) | baseline - 1 week |
| Concentration of OPG | osteoprotegerin (pg/ml) |
| Measure | Description | Time Frame |
|---|---|---|
| CAL | clinical attack level (mm) | baseline - 1 week |
| PPD | Probing Pocket Depth (mm) | baseline - 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of L'Aquila, division of periodontology | L’Aquila | 67100 | Italy |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D010510 | Periodontal Diseases |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D014080 | Tooth Exfoliation |
| ID | Term |
|---|---|
| D009063 | Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
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| scaling and root planning | Procedure | scaling and root planning |
|
| 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 |