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

NCT06836401 | Completed Phase 4

• 1 other identifier: USAL_Nº201700008745
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Periodontal Disease; Periodontal Inflammation

Keywords

periodontal pocket; periodontal disease; periodontal inflammation

Outcome Measures

Primary Outcomes (2)

• Probing depth

  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

  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

Study Arms (2)

Metronidazole

EXPERIMENTAL

These periodontal pockets will be treated with a metronidazole-based gel

Procedure: Root scaling; Drug: Topical Gel

Carbopole

SHAM COMPARATOR

These deep periodontal pockets (\>4mm) are treated with a placebo gel made of carbopol gel

Procedure: Root scaling; Drug: Topical Gel

Interventions

Root scaling PROCEDURE

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

Carbopole; Metronidazole

Topical Gel DRUG

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.

Carbopole; Metronidazole

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Salamanca: lead

Study Sites (1)

Dental School of the Faculty of Medicine

Salamanca, Salamanca, 37007, Spain

Location

MeSH Terms

Conditions

Periodontal Diseases; Periodontal Pocket

Interventions

Dental Scaling; Gels

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Periodontitis

Intervention Hierarchy (Ancestors)

Dental Prophylaxis; Periodontics; Dentistry; Preventive Dentistry; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Javier Montero, Main Researcher

  University of Salamanca

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Surgery

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: February 20, 2025
• Study Start: October 10, 2018
• Primary Completion: October 10, 2022
• Study Completion: November 10, 2022
• Last Updated: July 24, 2025

Record last verified: 2025-07

Locations

ES (1)