A NOVEL ORAL BIOADHESIVE FORMULATION INCORPORATED WITH NANOHYDROXYAPATITE AND ACORUS CALAMUS RHIZOME EXTRACT TOCOMBAT WHITE SPOT LESION- A RANDOMIZED CONTROLLED TRIAL
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To evaluate its efficacy in remineralization of white spot lesion.
研究概览
简要总结
Descriptionof Materials used:
Syntheticbiomimetic Hydroxyapatite which has nano sized particles, in the powder form isto be purchased from outside source. The extract of the rhizome of Acoruscalamus is to be done in the department of pharmacognosy,JSS College ofPharmacy. Acorus calamus alcoholic and aqueous extracts will be prepared by SOXHLETextraction and hot extraction process (refluxation). The MIC of the Acoruscalamus rhizome extract on the microorganisms causing white spot lesion i.e.Streptococcus mutans and Lactobacilllus acidophilus will be evaluated. Afterthe preparation of the oral bioadhesive formulation, 10% Nano Hydroxyapatiteand/or rhizome extract of Acorus calamus will be incorporated into it.
Investigationsto be done:
Biochemicalanalysis of saliva will be done to assess pH, Calcium and Phosphate levels.This is done in 3 phases for all the subjects. First before starting fixedorthodontic treatment which will be used as Baseline data, second during themid-phase of the treatment and then third after completion of the treatment.
Procedure:
Randomizationand group allocation: Eligible forty participants will be randomly selected andallocated to four different categories.
Group A:Oral bioadhesive formulation containing 10% Nano Hydroxyapatite.
Group B:Oral bioadhesive formulation containing rhizome extract of Acorus calamus.
Group C:Oral bioadhesive formulation containing both 10% Nano Hydroxyapatite andrhizome extract of Acorus calamus.
Group D:Control group.
Participantswill be instructed to maintain good oral hygiene status. The participants willbe asked to report immediately in case of any adverse effects to the contactdetails of investigator provided to him/ her.
Intervention:
After bonding of orthodontic brackets, eachpatient in the test group will be given oral bioadhesive formulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 25.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects aged 18-25 years.
- •Healthy subjects with no other systemic diseases 3.
排除标准
- •Subjects with systemic diseases
- •Individuals under any medication.
- •Individuals with high caries risk
- •Periodontally compromised individuals
- •Individuals unwilling to participate in the study.
结局指标
主要结局
To evaluate its efficacy in remineralization of white spot lesion.
时间窗: Total Duration of 18 months
To prepare an oral bioadhesive formulation with the use of nano hydroxyl apatite and herbal extract separately and in combination
时间窗: Total Duration of 18 months
次要结局
- To check the usability of Oral Bio adhesive for other than treating White spot lesion(18 months)