Evaluation of Effects of Subgingival Administration of Metronidazole Hydrogel 25% in Stage II and III Periodontitis: Randomized, Split Mouth, Single-blind Trial.
Overview
- Phase
- Phase 4
- Intervention
- metronidazole hydrogel
- Conditions
- Periodontitis
- Sponsor
- University of L'Aquila
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Concentration of TNF alfa
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
A randomized clinical trial will be performed single-blind to evaluate the effectiveness of sublingual metronidazole hydrogel 25 % in periodontitis.
Detailed 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.
Investigators
Enrico Marchetti
Prof. Enrico Marchetti
University of L'Aquila
Eligibility Criteria
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
Arms & Interventions
hydrogel metronidazole 25%
metronidazole hydrogel in adjunct to non surgical periodontal therapy
Intervention: metronidazole hydrogel
scaling and root planing
the only use of scaling and root planing
Intervention: scaling and root planning
Outcomes
Primary Outcomes
Concentration of TNF alfa
Time Frame: baseline - 1 week
tumor necrosis factor alfa (pg/ml)
Concentration of IL8
Time Frame: baseline - 1 week
interleukin (pg/ml)
Concentration of MMP8
Time Frame: baseline - 1 week
matrix metalloproteinases (ng/ml)
Concentration of MMP9
Time Frame: baseline - 1 week
matrix metalloproteinases (ng/ml)
Concentration of IL1
Time Frame: baseline - 1 week
interleukin (pg/ml)
Concentration of IL6
Time Frame: baseline - 1 week
interleukin (pg/ml)
Concentration of IL17
Time Frame: baseline - 1 week
interleukin (pg/ml)
Concentration of RANK-L
Time Frame: baseline - 1 week
Receptor activator of nuclear factor kappa-Β ligand (pg/ml)
Concentration of OPG
Time Frame: baseline - 1 week
osteoprotegerin (pg/ml)
Secondary Outcomes
- CAL(baseline - 1 week)
- PPD(baseline - 1 week)
- GI(baseline - 1 week)
- FMPS(baseline - 1 week)
- FMBS(baseline - 1 week)