Clinical trial NCT04983849: Evaluation of Metronidazole Hydrogel 25% in Stage II and III Periodontitis
Official title: Evaluation of Effects of Subgingival Administration of Metronidazole Hydrogel 25% in Stage II and III Periodontitis: Randomized, Split Mouth, Single-blind Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Periodontitis
Keywords: Periodontitis
Periodontal disease
Lead sponsor: University of L'Aquila
Sponsor class: OTHER
First posted: 2021-07-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Concentration of MMP8
timeFrame: baseline - 1 week
measure: Concentration of MMP9
timeFrame: baseline - 1 week
measure: Concentration of IL1
timeFrame: baseline - 1 week
measure: Concentration of IL6
timeFrame: baseline - 1 week
measure: Concentration of IL8
timeFrame: baseline - 1 week
measure: Concentration of IL17
timeFrame: baseline - 1 week
measure: Concentration of TNF alfa
timeFrame: baseline - 1 week
measure: Concentration of RANK-L
timeFrame: baseline - 1 week
measure: Concentration of OPG
timeFrame: baseline - 1 week
Secondary outcomes:
measure: CAL
timeFrame: baseline - 1 week
measure: PPD
timeFrame: baseline - 1 week
measure: GI
timeFrame: baseline - 1 week
measure: FMPS
timeFrame: baseline - 1 week
measure: FMBS
timeFrame: baseline - 1 week
Other outcomes:
Locations:
city: L'Aquila
country: Italy
facility: University of L'Aquila, division of periodontology
Study officials:
References: