Comparative Evaluation of Chlorhexidine, Metronidazole and Combination Gels on Gingivitis

NCT03142607 | Unknown Phase 3 DMC

• 1 other identifier: 4577-Sur-ERC-16
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Gingivitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (3)

Group A

ACTIVE COMPARATOR

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

Group B

ACTIVE COMPARATOR

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

Group C

ACTIVE COMPARATOR

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: Metronidazole gel; Drug: Chlorhexidine Gluconate

Interventions

Metronidazole gel DRUG

1% Metronidazole gel

Also known as: Revomet gel

Group B; Group C

Chlorhexidine Gluconate DRUG

0.2% Chlorhexidene gluconate gel

Also known as: Clinica gel

Group A; Group C

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aga Khan University: lead

Study Sites (1)

Aga Khan University

Karachi, Sindh, 74800, Pakistan

RECRUITING

MeSH Terms

Conditions

Gingivitis

Interventions

chlorhexidine gluconate

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Robia Ghafoor, BDS, FCPS

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robia Ghafoor, BDS, FCPS

CONTACT

00922134864374; robia.ghafoor@aku.edu

Sheikh Bilal Badar, BDS

CONTACT

00923452388775; sbilalbadar@gmail.com, sheikh.badar@aku.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Investigator

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

Study Record Dates

• First Submitted: April 28, 2017
• First Posted: May 5, 2017
• Study Start: February 3, 2017
• Primary Completion: January 2, 2018
• Study Completion: February 2, 2018
• Last Updated: May 5, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)