Comparative Evaluation of Chlorhexidine, Metronidazole and Combination Gels on Gingivitis

Comparative Evaluation of Chlorhexidine, Metronidazole and Combination Gels on Gingivitis: A Randomized Clinical Trial

Patient presenting to the dental clinic with gingivitis and fulfilling the inclusion criteria will be included in the study after taking informed consent. Participants will be divided into three groups. Each group will be instructed to apply metronidazole gel, chlorhexidine gel or combination of metronidazole and chlorhexidine gel on the marginal gingiva. Measurement for the gingival index will be taken at baseline, at 2 weeks and at 4 weeks interval

Study Overview

• Status: Unknown
• Conditions: Gingivitis
• Intervention / Treatment: Drug: Chlorhexidine Gluconate; Drug: Metronidazole gel

Detailed Description

Training of the examiner:

Participating investigators(Resident and supervisor) will be trained and calibrated on the development of the trial, case selection, measurement techniques, sample collection, data compilation sheets and their precise role in the study. In order to evaluate the intra-examiner reliability, five subjects not involved in the study will be evaluated twice by each investigator for the measurements at the interval of one week.

Methodology:

On the first visit after clinical examination, the specially designed baseline study proforma will be filled-in. The bleeding sites, probing depth and the gingival index score will be calculated.

Group A subjects will be instructed to apply a standard 0.2 % Chlorhexidine gel (clinica gel) on the marginal gingiva for the next 14 days, twice a day for 30 minutes, after morning and evening tooth brushing.

Group B subjects will be instructed to apply 0.8 % Metronidazole gel (anaerobic gel) twice daily for 30 minutes after morning and evening tooth brushing for two weeks.

Group C subjects will be instructed to apply 0.2 % Chlorhexidine gel (clinica gel) on the marginal gingiva after morning tooth brushing for 30 minutes and 0.8 % metronidazole gel (anaerobic gel) after evening tooth brushing for 30 minutes for two weeks. Subjects in these groups will receive the detailed and precise instruction and demonstrations on the diurnal alternate application of the two gels.

The application of the topical gels will be halted after 2 weeks and second clinical examination will be carried out for bleeding sites, probing depth and the gingival index score. Scaling & polishing of teeth in all three groups and oral hygiene instructions will be reinforced. Subjects will be recalled at 4 week for evaluation of gingival and oral hygiene indices. The reading will be recorded in the study proforma.

Randomization, blinding and treatment allocation:

Subjects will be assigned to one of the three study groups using a computer generated randomization list. The recruitment of the patients will be performed by one investigator. All the measurements at the baseline and follow ups will be performed by the second investigator. Patient, the operator (until the gel will be handed over by the dental assistant), the investigator who is taking the measurement and the statistician will be blinded about the intervention groups. This will be ensured by giving codes to the intervention groups only known to the principal investigator who is not involved in the measurement and interaction with the patient.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Robia Ghafoor, BDS, FCPS; Phone Number: 00922134864374; Email: robia.ghafoor@aku.edu
• Study Contact Backup: Name: Sheikh Bilal Badar, BDS; Phone Number: 00923452388775; Email: sbilalbadar@gmail.com, sheikh.badar@aku.edu

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 74800
      • Recruiting
      • Aga Khan University
      • Contact: Robia Ghafoor, BDS, FCPS; Phone Number: 00922134864374; Email: robia.ghafoor@aku.edu
      • Contact: Sheikh Bilal Badar, BDS; Phone Number: 00923452388775; Email: sbilalbadar@gmail.com, sheikh.badar@aku.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients having 20 or more healthy teeth
• Systematically healthy patient with no co-morbid
• Subjects with clinically confirmed gingivitis having positive bleeding gums on probing in every sextant
• Subjects having teeth without any clinical attachment loss

Exclusion criteria:

• Subjects with clinical attachment loss of greater than 2 mm on two sites
• Pregnant or lactating females
• Subjects with removal or fixed dental prosthesis
• History of surgical or nonsurgical periodontal therapy in the last 6 months
• Use of antibiotic in the last 30 days
• Habit of smoking or use of smokeless tobacco
• Allergic to Metronidazole or Chlorhexidine
• Presence of any craniofacial syndrome patients
• Patients on medications that have effects on gingival conditions (such as Nifedipine, Cyclosporine and Phenytoin etc.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; subjects will be instructed to apply a standard 0.2 % Chlorhexidine gel (clinica gel) on the marginal gingiva for the next 14 days, twice a day for 30 minutes, after morning and evening tooth brushing	Drug: Chlorhexidine Gluconate; 0.2% Chlorhexidene gluconate gel; Other Names: Clinica gel
Active Comparator: Group B; Subjects will be instructed to apply 0.8 % Metronidazole gel (anaerobic gel) twice daily for 30 minutes after morning and evening tooth brushing for two weeks	Drug: Metronidazole gel; 1% Metronidazole gel; Other Names: Revomet gel
Active Comparator: Group C; subjects will be instructed to apply 0.2 % Chlorhexidine gel (clinica gel) on the marginal gingiva after morning tooth brushing for 30 minutes and 0.8 % metronidazole gel (anaerobic gel) after evening tooth brushing for 30 minutes for two weeks. Subjects in these groups will receive the detailed and precise instruction and demonstrations on the diurnal alternate application of the two gels	Drug: Chlorhexidine Gluconate; 0.2% Chlorhexidene gluconate gel; Other Names: Clinica gel; Drug: Metronidazole gel; 1% Metronidazole gel; Other Names: Revomet gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Gingival Index	On each appointment, gingival index values will be evaluated and change in the gingival index will be noted.	Two weeks and four weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in Oral Hygiene Index	Two weeks and four weeks
Change in Bleeding index	Two weeks and four weeks
Change in Probing depth	Two weeks and four weeks

Collaborators and Investigators

• Sponsor: Aga Khan University
• Investigators: Principal Investigator: Robia Ghafoor, BDS, FCPS, Aga Khan University

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2017
• Primary Completion (Anticipated): January 2, 2018
• Study Completion (Anticipated): February 2, 2018

Study Registration Dates

• First Submitted: April 28, 2017
• First Submitted That Met QC Criteria: May 4, 2017
• First Posted (Actual): May 5, 2017

Study Record Updates

• Last Update Posted (Actual): May 5, 2017
• Last Update Submitted That Met QC Criteria: May 4, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Gingivitis; Anti-Infective Agents, Local; Anti-Infective Agents; Dermatologic Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Disinfectants; Metronidazole; Chlorhexidine; Chlorhexidine gluconate
• Other Study ID Numbers: 4577-Sur-ERC-16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No