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临床试验/CTRI/2024/03/064399
CTRI/2024/03/064399尚未招募3 期

The Effect of Nanohydroxyapatite Containing Cream, Diode Laser and its Combination in relieving dentine hypersensitivity: An In Vivo study

Dr Konthoujam Bijaya Devi1 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2024年3月30日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
57
试验地点
1
主要终点
Comparison of Nanohydroxyapatite Containing Cream, Diode laser & their combination effect in relieving dentine hypersensitivity at 1st, 7th & 14th day

研究概览

简要总结

Aim:

The aim of this in vivo study is to evaluate the clinical efficacy of Nanohydroxyapatite containing cream, Laser & their combination effect in relieving dentine hypersensitivity.

Objective:

Comparison of Nanohydroxyapatite Containing Cream, Diode laser & their combination effect in relieving dentine hypersensitivity at 1st, 7th & 14th day.

MATERIALS AND METHOD:

The ethical committee approval is obtained from Institutional Ethical Committee (SDCRI/IEC/D/24/03) of Surendera Dental College and Research Institute, Sri Ganganagar, Rajasthan, and trial will be registered in the Clinical Trials Registry India (CTRI).

1. Source of Data:

This study will be carried out in the Department of Conservative Dentistry & Endodontics and Department of Periodontology & Oral Implantology, Surendera Dental College & Research Institute, Sri Ganganagar, Rajasthan, India.

2. Armamentarium:

1.     Cotton roll

2.     Disposable applicator tip

3.     Explorer #23

4.     Disposable syringe (0.2ml)

3. Materials used:

1.     Nanohydroxyapatite containing cream (Fang, Couch Commerce Pvt. Ltd, India)

4. Equipments used:

  1. Diode Laser (Biolase 4 Cromwell Irvine, Made in USA)

5. Methods of Collection of Data:

A total 57 participants between the age group of 20-60years with the complaint of dentinal hypersensitivity will be included in this study.

Inclusion criteria:

1.     Presence of minimum of two hypersensitive teeth

2.     Hypersensitivity of teeth to tactile, air stimulus & cold water

3.     Verbal analog scale (VAS) score >3

4.     Gingival recession

5.     Cuneiform defects-incorrect brushing technique

6.     Patients in good systemic health with clinically elicitable DH

7.     Absence of contraindications to the proposed therapies (e.g., allergies to desensitizing agent)

Exclusion criteria:

1.     Dental caries, Wasting diseases, Fractures

2.     Defective Fillings

3.     Cracks of the tooth

4.     Patients with clinical or radiograph evidence of pulp pathology

5.     Any periodontal surgery-preceding 6 months

6.     Deep periodontal pocket

The reported hypersensitive teeth in the subjects will be verified by light strokes of dental explorer along the cervical areas of all teeth present. This study will explain to the subjects and informed consent will be taken. The potential target sites will isolate with cotton rolls and sensitivity will be evaluated with 3 stimulus tests, each of these tests will be performed at the time gap of 5mins.

·  Tactile test: Dental explorer will be gently run across the affected surface of the   tooth.

·       Air blast test: A blast of air from a 3-way dental syringe for 3sec from 1cm distance.

·       Cold water test: Ice cold water will be slowly expelled onto the tooth surface with disposable syringe (0.2ml).

All the three tests will be applied in the ascending order of discomfort, i.e., tactile test (least disturbing) then air blast test and at last cold water test (most disturbing). The stimuli will be applied in the same order, at a time interval of 5 min each.

Sensitivity score will be recorded with verbal analog scale (VAS).

Verbal analog scale :- 0: No sensitivity;1–3 Mild sensitivity; 4–6 Moderate       sensitivity ;7–10: Severe sensitivity)

DIVISION OF GROUP:

57 participants will be randomly assigned to three experimental groups according to the material and equipment used. 19 patients in each group.

Group 1: Nanohydroxyapatite containing cream (Fang Couch Commerce Pvt.Ltd,  India)

Group 2: Diode Laser (Biolase 4 Cromwell Irvine, Made in USA)

Group 3: Nanohydroxyapatite (Fang) + Diode laser (Biolase)

Procedure will be repeated at 1st,7th & 14th day for all the groups. The score will be recorded from all the participants of each group, after every session of application i.e, 1st, 7th, 14th day.

The results will be analysed with one way ANOVA.

GROUP

MATERIAL

COMPOSITION

MODE OF APPLICATION

|1.

FANG

 Nanohydroxyapatite active ingrediants

Isolation with cotton roll. Pea sized desensitizing agent will be taken on the applicator tip & apply on the tooth surface & left for 15min and rinse

|2.

LASER

 Laser application with 940nm (2W), continuous non contact mode, in a distance of 1mm & in an oblique manner for 10 secs.

|3.

FANG + LASER

 Fang (nHAP) for 15min, then laser application will be done with the same parameter as mention above and rinse

研究设计

研究类型
Interventional
分配方式
Other
盲法
None

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Presence of minimum of two hypersensitive teeth Hypersensitivity of teeth to tactile, air stimulus & cold water Verbal analog scale VAS score more than 3 Gingival recession Cuneiform defects-incorrect brushing technique Patients in good systemic health with clinically elicitable DH Absence of contraindications to the proposed therapies allergies to desensitizing agent.

排除标准

  • Dental caries, Wasting diseases, Fractures Defective Fillings Cracks of the tooth Patients with clinical or radiograph evidence of pulp pathology Any periodontal surgery-preceding 6 months Deep periodontal pocket.

结局指标

主要结局

Comparison of Nanohydroxyapatite Containing Cream, Diode laser & their combination effect in relieving dentine hypersensitivity at 1st, 7th & 14th day

时间窗: at baseline,1 week, 2 weeks

次要结局

  • Comparison of Nanohydroxyapatite Containing Cream, Diode laser & their combination effect in relieving dentine hypersensitivity at 1st, 7th & 14th day(At baseline a week two weeks)

研究者

发起方
Dr Konthoujam Bijaya Devi
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Konthoujam Bijaya devi

Rajasthan University of Health and Sciences

研究点 (1)

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