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

Phase 4

Completed

• Conditions: Periodontitis
• Interventions: Drug: metronidazole hydrogel; Procedure: scaling and root planning

• Registration Number: NCT04983849
• Lead Sponsor: University of L'Aquila

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.

Study Timeline

• Study Start: 2021-07-07
• Primary Completion: 2021-07-07
• Study Completion: 2021-07-07
• Study First Submitted: 2021-07-20
• Study First Submitted QC: 2021-07-20
• Study First Posted: 2021-07-30
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-05
• Last Update Posted: 2023-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
hydrogel metronidazole 25%	metronidazole hydrogel	metronidazole hydrogel in adjunct to non surgical periodontal therapy
scaling and root planing	scaling and root planning	the only use of scaling and root planing

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of L'Aquila, division of periodontology; 🇮🇹 L'Aquila, Italy