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.

A randomized clinical trial will be performed single-blind to evaluate the effectiveness of sublingual metronidazole hydrogel 25 % in periodontitis.

Study Overview

• Status: Completed
• Conditions: Periodontitis
• Intervention / Treatment: Drug: metronidazole hydrogel; Procedure: scaling and root planning

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • L'Aquila, Italy, 67100
    • University of L'Aquila, division of periodontology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: hydrogel metronidazole 25%; metronidazole hydrogel in adjunct to non surgical periodontal therapy	Drug: metronidazole hydrogel; scaling and root planning in adjunct to the use of metronidazole in the periodontal pocket; Other Names: Non Surgical Periodontal Therapy
Active Comparator: scaling and root planing; the only use of scaling and root planing	Procedure: scaling and root planning; scaling and root planning

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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-Β ligand (pg/ml)	baseline - 1 week
Concentration of OPG	osteoprotegerin (pg/ml)	baseline - 1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CAL	clinical attack level (mm)	baseline - 1 week
PPD	Probing Pocket Depth (mm)	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

Collaborators and Investigators

• Sponsor: University of L'Aquila

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2021
• Primary Completion (Actual): July 7, 2021
• Study Completion (Actual): July 7, 2021

Study Registration Dates

• First Submitted: July 20, 2021
• First Submitted That Met QC Criteria: July 20, 2021
• First Posted (Actual): July 30, 2021

Study Record Updates

• Last Update Posted (Estimated): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Periodontitis; Periodontal disease
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Metronidazole
• Other Study ID Numbers: Prot. RCT 001/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No