Topical Metronidazole vs Control in Reducing Periodontal Pockets in a Split Mouth Clinical Trial (Perio_topic)

July 21, 2025 updated by: JAVIER MONTERO, University of Salamanca

Effect of Topical Metronidazole in Reducing Periodontal Probing Depth: A Split Mouth Clinical Trial

The effect of both the mechanical treatment and the topical metronidazol in reduccing the inflammation and depth of the periodontal pockets were assessed on the first bicuspids.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Salamanca, Spain, 37007
        • Dental School of the Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Periodontal patients with all first premolars suffering from moderate periodontal pockets (>4mm of probing depth)

Exclusion Criteria:

  • No patients received antibiotics nor periodontal treatment in the previous 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Metronidazole
These periodontal pockets will be treated with a metronidazole-based gel
Procedure: Root scaling
Scaling and root planing is a deep cleaning below the gumline used to remove plaque and tartar that cover the root in the periodontal pockets. This intervention is carried out in both control and experimental sites
Drug: Topical Gel
A gel (experimental: metronidazole VS control: carbopol) is introduced in the recently cleaned periodontal pocket. The allocation of either experimental or control gel was distributed randomly, being masked both the patient and the clinician.
Sham Comparator: Carbopole
These deep periodontal pockets (>4mm) are treated with a placebo gel made of carbopol gel
Procedure: Root scaling
Scaling and root planing is a deep cleaning below the gumline used to remove plaque and tartar that cover the root in the periodontal pockets. This intervention is carried out in both control and experimental sites
Drug: Topical Gel
A gel (experimental: metronidazole VS control: carbopol) is introduced in the recently cleaned periodontal pocket. The allocation of either experimental or control gel was distributed randomly, being masked both the patient and the clinician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Probing depth
Time Frame: Both one month and three months after root scaling
Probing depth is assessed at 6 points around the first bicuspids (mesiovestibular, midvestibular, distovestibular, mesiolingual, midlingual, distolingual)
Both one month and three months after root scaling
Mieloperoxidase ng/mL
Time Frame: Both one and three months after root scaling
The determination of the quantity of mieloperoxidase ng/mL was assessed from the crevicular fluid of the treated bicuspids
Both one and three months after root scaling

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Salamanca

Investigators

  • Principal Investigator: Javier Montero, Main Researcher, University of Salamanca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2018

Primary Completion (Actual)

October 10, 2022

Study Completion (Actual)

November 10, 2022

Study Registration Dates

First Submitted

February 14, 2025

First Submitted That Met QC Criteria

February 19, 2025

First Posted (Actual)

February 20, 2025

Study Record Updates

Last Update Posted (Actual)

July 24, 2025

Last Update Submitted That Met QC Criteria

July 21, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USAL_Nº201700008745

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

This work is planned to be a PhD dissertation and we are not sure if sharing data would hamper the originality of the future thesis

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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