NCT03142607

Comparative Evaluation of Chlorhexidine, Metronidazole and Combination Gels on Gingivitis

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Aga Khan University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Gingivitis

Interventions

Type	Name	Description
DRUG	Metronidazole gel	1% Metronidazole gel
DRUG	Chlorhexidine Gluconate	0.2% Chlorhexidene gluconate gel

Timeline

• Start date: 2017-02-03
• Primary completion: 2018-01-02
• Completion: 2018-02-02
• First posted: 2017-05-05
• Last updated: 2017-05-05

Locations

1 site across 1 country: Pakistan