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

NCT04983849 | Completed Phase 4 DMC

• 1 other identifier: Prot. RCT 001/2021
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Periodontitis

Keywords

Periodontitis; Periodontal disease

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (5)

• CAL

  baseline - 1 week

• PPD

  baseline - 1 week

• GI

  baseline - 1 week

• FMPS

  baseline - 1 week

• FMBS

  baseline - 1 week

Study Arms (2)

hydrogel metronidazole 25%

ACTIVE COMPARATOR

metronidazole hydrogel in adjunct to non surgical periodontal therapy

Drug: metronidazole hydrogel

scaling and root planing

ACTIVE COMPARATOR

the only use of scaling and root planing

Procedure: scaling and root planning

Interventions

metronidazole hydrogel DRUG

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

Also known as: Non Surgical Periodontal Therapy

hydrogel metronidazole 25%

scaling and root planning PROCEDURE

scaling and root planning

scaling and root planing

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• % of sites with survey depth 5 mm
• Comparable pockets in 4 mouth quadrants
• Health at systemic level

You may not qualify if:

• 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

Sponsors & Collaborators

• University of L'Aquila: lead

Study Sites (1)

University of L'Aquila, division of periodontology

L’Aquila, 67100, Italy

Location

MeSH Terms

Conditions

Periodontitis; Periodontal Diseases

Interventions

Tooth Exfoliation

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Enrico Marchetti

Study Record Dates

• First Submitted: July 20, 2021
• First Posted: July 30, 2021
• Study Start: July 7, 2021
• Primary Completion: July 7, 2021
• Study Completion: July 7, 2021
• Last Updated: December 12, 2023

Record last verified: 2023-12

Locations

IT (1)