Triple Blind Randomized Clinical Trial on effectiveness of three topical fluorides in arresting Dental Caries in Junior School children

Not yet recruiting

Conditions: Healthy children with atleast one active caries lesion

Registration Number: CTRI/2019/10/021763

Lead Sponsor: Dr Gayathri

Brief Summary: **AIM AND OBJECTIVES**

Aim of this study is to compare the effectiveness of Silver Diamine Fluoride, Sodium Fluoride varnish, Sodium Fluoride varnish with Calcium and Phosphate in arresting dental caries in primary teeth of Junior School children with ECC over a period of 12 months.

**MATERIALS AND METHODS**

***Trial Design***

This is a single centred, triple blinded, randomized clinical trial for a period of 12 months.

***Participants***

The study will be conducted in Junior School children (2 to 5 years of age) reporting to the Department of Pediatric and Preventive dentistry, Meenakshi Ammal Dental College, Chennai. Ethical approval has been obtained from the Institutional Review Board of the University of MAHER and the trial will be registered in the Clinical trials registry. A consent will be obtained from the parents of all the children who will be participating in the study, after explaining the purpose and procedures of the study. A thorough screening will be done at the baseline. The dmft score and visible plaque index will be recorded. The caries status is recorded based on the International Caries Detection and Assessment System (ICDAS).

***INCLUSION CRITERIA :***

Healthy junior school children aged 2 to 5 years who have at least one tooth with untreated active dental caries not involving pulp with the ICDAS score of 5 and 6 will be included in the study.

***EXCLUSION CRITERIA :***

i.         Junior school children with any associated medical illness

ii.         Junior school children with silver or fluoride allergy

iii.         Primary teeth with arrested caries

iv.         Primary teeth with caries extending to the pulp

v.         Primary teeth with pathological mobility

vi.         Primary teeth with Caries leading to abscess

vii.         Non-vital primary teeth

***ARMAMENTARIUM :***

i.         Electrically operated dental chair with light and 3 way air-water syringe

ii.         Mouth mirror

iii.         Ball end probe (405/WHO CPI probe)

iv.         Cotton wool

v.         Cotton rolls

vi.         Vaseline

vii.         Dappen dish

viii.         Disposable micro brush

ix.         Disposable gloves

x.         Disposable face mask

xi.         Disposable patient drapes

xii.         Materials â€“ Silver diamine fluoride solution, Sodium fluoride varnish, Sodium fluoride varnish with calcium and phosphate.

***SAMPLE SIZE CALCULATION***:

The sample size calculated by ANOVA test was found to be 111 preschool children (37 for each group) with a power of 80% and type I error of 5% based on a previous study by Chu, Lo and Lin (2002).

***RANDOMIZATION*** *:*

Participating children will be allocated by a simple randomization.

***INTERVENTION :***

The selected participants will be randomly divided into the following three groups

Group I:             Silver diamine fluoride application

Group II:            Sodium fluoride varnish application

Group III:          Sodium fluoride varnish with

calcium and phosphate application

***PROCEDURE:***

A dental student who is not involved in the examination of the children will be applying the topical fluoride according to the group allocation without carious tissue removal. The corresponding topical fluoride will be placed in a dappen dish and a disposable micro brush will be used to apply on to each carious lesion surface. The same is repeated at the end of 6and 12 months from the baseline.

***OUTCOME:***

The outcome measures will be evaluated by follow up examinations conducted at 6 and 12 months from the baseline by a blinded examiner. Carious lesion activity will be assessed by visual inspection and tactile detection using the ball end probe. Light force will be used to avoid damaging the tooth during probing. If the cavity wall or floor would be easily penetrated by the ball end probe using light force, it would be diagnosed as â€œcaries-activeâ€. Carious lesions with smooth and hard surfaces will be classified as arrested caries.

***STATISTICAL METHODS:***

Collected data will be analysed statistically.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 111

Inclusion Criteria

Healthy Junior School children aged 2 to 5 years who have atleast one tooth with untreated active dental caries not involving pulp with ICDAS score of 5 and 6 are included.

Exclusion Criteria

i.Junior school children with any associated medical illness ii.Junior school children with silver or fluoride allergy iii.Primary teeth with arrested caries iv.Primary teeth with caries extending to the pulp v.Primary teeth with pathological mobility vi.Primary teeth with Caries leading to abscess vii.Non-vital primary teeth.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Arrest of caries	6 months

Secondary Outcome Measures

Name	Time	Method
Arrest of caries	1 year

Trial Locations

Locations (1): Meenakshi Ammal Dental college and Hospital
🇮🇳
Chennai, TAMIL NADU, India
Meenakshi Ammal Dental college and Hospital
🇮🇳Chennai, TAMIL NADU, India
Dr Gayathri
Principal investigator
9841693008
drgayathrijagan@gmail.com