Application of antimicrobial gel aiming to treat periodontal disease (gingival disease)

Clinical evaluation of metronidazole semi-solid and film-forming formulations for the treatment of periodontal disease

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

REBEC

Registry ID

RBR-68bwkc

Enrollment

Unknown

Registered

2018-09-14

Start date

2015-05-05

Completion date

Unknown

Last updated

2025-10-27

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

Conditions

Periodontal disease/Chronic periodontitis

Interventions

A randomized clinical trial was conducted to test the hypothesis that the use of the local delivery system (film or gel) to scaling and root planing (RAR) is superior to RAR alone. A total of 45 patie

• Group 2 - RAR + film with metronidazole - 15 individuals

• Group 3 - RAR + metronidazole gel - 15 individuals.

Drug

Device

D02.640.672.500

E02.319.300

Eligibility

Age

35 Years to 70 Years

Inclusion criteria

Inclusion criteria: Chronic periodontitis with a clinical insertion level equal to or greater than 5 mm in two or more teeth and depth of probing equal to or greater than 5 mm in one or more periodontal sites (MACHTEI et al., 1992); age range from 35 to 70 years; not have used antibiotics for at least 3 months; absence of history of allergy to the components present in the formulations tested.

Exclusion criteria

Exclusion criteria: Volunteers with severe cardiovascular disease; volunteers with problems related to pharmacokinetics, such as nephropathies, liver diseases, etc.

Design outcomes

Primary

Measure	Time frame
Detect and quantify the intra-periodontal pocket presence of the drug after 48 hours of periodontal treatment for both different treatments;It was possible to detect and quantify the presence of periodontal intrabola drug after 48 hours of periodontal treatment. There was no statistically significant difference between the groups evaluated (film and gel);Difference in depth of probing and bleeding after probing for the three treatment groups;Patients who received conventional periodontal treatment associated with drug placement through the film (RAR + film) showed progressive reduction in depth of probing values, which lasted up to 90 days after treatment; There was a progressive reduction of bleeding at the T15 and T30 times in the three groups evaluated, but in the long term (T60 and T90) the gel and film treatments were better than the isodated RAR	—

Measure

Time frame

Detect and quantify the intra-periodontal pocket presence of the drug after 48 hours of periodontal treatment for both different treatments;It was possible to detect and quantify the presence of periodontal intrabola drug after 48 hours of periodontal treatment. There was no statistically significant difference between the groups evaluated (film and gel);Difference in depth of probing and bleeding after probing for the three treatment groups;Patients who received conventional periodontal treatment associated with drug placement through the film (RAR + film) showed progressive reduction in depth of probing values, which lasted up to 90 days after treatment; There was a progressive reduction of bleeding at the T15 and T30 times in the three groups evaluated, but in the long term (T60 and T90) the gel and film treatments were better than the isodated RAR

—

Secondary

Measure	Time frame
Modification at the clinical level of insertion for the 3 groups;At the clinical level of insertion there was a statistically significant difference between the three groups evaluated, and the group that received only conventional periodontal treatment presented the best values	—

Countries

Brazil

Contacts

Public ContactVinicius Pedrazzi

Faculdade De Odontologia de Ribeirão Preto

pedrazzi@forp.usp.br+55 16 3315-4008

Outcome results

None listed

Source: REBEC (via WHO ICTRP)