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Completed

NCT Number: NCT04983849

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

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of L'Aquila, division of periodontology

L’Aquila, 67100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

metronidazole hydrogel

Drug

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

Other names: Non Surgical Periodontal Therapy

Scaling and root planning

Procedure

scaling and root planning

Primary outcomes

  1. Concentration of MMP8

    Time frame: baseline - 1 week

    matrix metalloproteinases (ng/ml)

  2. Concentration of MMP9

    Time frame: baseline - 1 week

    matrix metalloproteinases (ng/ml)

  3. Concentration of IL1

    Time frame: baseline - 1 week

    interleukin (pg/ml)

  4. Concentration of IL6

    Time frame: baseline - 1 week

    interleukin (pg/ml)

  5. Concentration of IL8

    Time frame: baseline - 1 week

    interleukin (pg/ml)

  6. Concentration of IL17

    Time frame: baseline - 1 week

    interleukin (pg/ml)

  7. Concentration of TNF alfa

    Time frame: baseline - 1 week

    tumor necrosis factor alfa (pg/ml)

  8. Concentration of RANK-L

    Time frame: baseline - 1 week

    Receptor activator of nuclear factor kappa-Β ligand (pg/ml)

  9. Concentration of OPG

    Time frame: baseline - 1 week

    osteoprotegerin (pg/ml)

Secondary outcomes

  1. CAL

    Time frame: baseline - 1 week

    clinical attack level (mm)

  2. PPD

    Time frame: baseline - 1 week

    Probing Pocket Depth (mm)

  3. GI

    Time frame: baseline - 1 week

    gingival index (0-3)

  4. FMPS

    Time frame: baseline - 1 week

    full mouth plaque score (0-100%)

  5. FMBS

    Time frame: baseline - 1 week

    full mouth bleeding score (0-100%)

Sponsors and collaborators

Lead sponsor

University of L'Aquila

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 30, 2021
Registry last updated
Dec 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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