Comparative Evaluation of Chlorhexidine, Metronidazole and Combination Gels on Gingivitis: A Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in Gingival Index
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- 未提供
研究组 & 干预措施
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
干预措施: Chlorhexidine Gluconate (Drug)
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
干预措施: Metronidazole gel (Drug)
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
干预措施: Metronidazole gel (Drug)
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
干预措施: Chlorhexidine Gluconate (Drug)
结局指标
主要结局
Change in Gingival Index
时间窗: Two weeks and four weeks
On each appointment, gingival index values will be evaluated and change in the gingival index will be noted.
次要结局
- Change in Oral Hygiene Index(Two weeks and four weeks)
- Change in Probing depth(Two weeks and four weeks)
- Change in Bleeding index(Two weeks and four weeks)
研究者
Sheikh Bilal Badar
Resident Investigator
Aga Khan University