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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04983849

Enrollment

Registered

2021-07-30

Start date

2021-07-07

Completion date

2021-07-07

Last updated

2023-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontitis

Keywords

Periodontitis, Periodontal disease

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.

Interventions

DRUGmetronidazole hydrogel

scaling and root planning in adjunct to the use of metronidazole in the periodontal pocket

PROCEDUREscaling and root planning

scaling and root planning

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Concentration of OPG	baseline - 1 week	osteoprotegerin (pg/ml)
Concentration of IL6	baseline - 1 week	interleukin (pg/ml)
Concentration of IL8	baseline - 1 week	interleukin (pg/ml)
Concentration of IL17	baseline - 1 week	interleukin (pg/ml)
Concentration of TNF alfa	baseline - 1 week	tumor necrosis factor alfa (pg/ml)
Concentration of RANK-L	baseline - 1 week	Receptor activator of nuclear factor kappa-Β ligand (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)

Secondary

Measure	Time frame	Description
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%)
FMBS	baseline - 1 week	full mouth bleeding score (0-100%)
CAL	baseline - 1 week	clinical attack level (mm)

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026