Comparative Evaluation of Chlorhexidine, Metronidazole and Combination Gels on Gingivitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-03

Study Completion Date

2018-02-02

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Gingivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Group A has Metronidazole gel Group B has Chlorhexidene gel Group C has combination of metronidazole and chlorhexidene gel

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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 care provider, 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 Groups

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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 Type ACTIVE_COMPARATOR

Chlorhexidine Gluconate

Intervention Type DRUG

0.2% Chlorhexidene gluconate gel

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 Type ACTIVE_COMPARATOR

Metronidazole gel

Intervention Type DRUG

1% Metronidazole gel

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

Group Type ACTIVE_COMPARATOR

Metronidazole gel

Intervention Type DRUG

1% Metronidazole gel

Chlorhexidine Gluconate

Intervention Type DRUG

0.2% Chlorhexidene gluconate gel

Interventions

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Metronidazole gel

1% Metronidazole gel

Intervention Type DRUG

Chlorhexidine Gluconate

0.2% Chlorhexidene gluconate gel

Intervention Type DRUG

Other Intervention Names

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Revomet gel Clinica gel

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes