| CTRI Number |
CTRI/2021/08/035936 [Registered on: 25/08/2021] Trial Registered Prospectively |
| Last Modified On: |
08/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Caries-preventive effectiveness of adding an antibacterial agent to fluoride varnish among 4-6-year-old children |
|
Scientific Title of Study
|
Effectiveness of adding an antibacterial agent (Povidone iodine or Chlorhexidine) to fluoride varnish on caries prevention among 4–6-year-old school children – A randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arpit Gupta |
| Designation |
Assistant Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Oral Health Sciences Centre
PGIMER
SECTOR 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8826674284 |
| Fax |
|
| Email |
arpitg.in@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Arpit Gupta |
| Designation |
Assistant Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Oral Health Sciences Centre
PGIMER
SECTOR 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8826674284 |
| Fax |
|
| Email |
arpitg.in@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Arpit Gupta |
| Designation |
Assistant Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Oral Health Sciences Centre
PGIMER
SECTOR 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8826674284 |
| Fax |
|
| Email |
arpitg.in@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Health Research (DHR), New Delhi |
|
|
Primary Sponsor
|
| Name |
Department of Health Research MoHFW GoI |
| Address |
Red Cross Road
New Delhi-110001 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Arpit Gupta |
Postgraduate Institute of Medical Education and Research |
Oral Health Sciences Centre
Unit of Public Health Dentistry
Sector 12
Chandigarh
CHANDIGARH |
8826674284
arpitg.in@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, PGIMER, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
All 4–6-year-old Government school children without no history of allergy to fluoride varnish, chlorhexidine and povidone iodine, or no debilitating illness/disease/ongoing orthodontic treatment |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1% Chlorhexidine and 5% sodium fluoride varnish application |
Two-step application procedure
Child will be comfortably seated on the portable dental chair in upright position. Plaque will be
removed from the surfaces of the teeth by wiping with cotton gauze. In the first step, 0.25 mL of
the allocated formulation will be dispensed in the dispensing wells. The teeth will be dried using
cotton gauze and isolated. The formulation will be applied and allowed to dry up while maintaining
complete isolation using suction tips. In the second step, 0.25 mL of 5% NaF varnish will be
dispensed in the dispensing wells and will be applied on all the teeth using an applicator tip by
using paint on technique. Adequate isolation will be ensured by the use of suction tips throughout
the application procedure. After varnish application, the patient will be made to sit with the mouth
open for 4 minutes with adequate suction. Thereafter, children will be advised not to rinse or drink
anything for half an hour. Parents will be informed to give liquid and semisolid food items on the
day of varnish application and avoid tooth brushing at the night. |
| Intervention |
10% povidone iodine solution followed by 5% sodium fluoride varnish application |
Two-step application procedure
Child will be comfortably seated on the portable dental chair in upright position. Plaque will be
removed from the surfaces of the teeth by wiping with cotton gauze. In the first step, 0.25 mL of
the allocated formulation will be dispensed in the dispensing wells. The teeth will be dried using
cotton gauze and isolated. The formulation will be applied and allowed to dry up while maintaining
complete isolation using suction tips. In the second step, 0.25 mL of 5% NaF varnish will be
dispensed in the dispensing wells and will be applied on all the teeth using an applicator tip by
using paint on technique. Adequate isolation will be ensured by the use of suction tips throughout
the application procedure. After varnish application, the patient will be made to sit with the mouth
open for 4 minutes with adequate suction. Thereafter, children will be advised not to rinse or drink
anything for half an hour. Parents will be informed to give liquid and semisolid food items on the
day of varnish application and avoid tooth brushing at the night. |
| Comparator Agent |
Placebo solution followed by 5% sodium fluoride application |
Two-step application procedure
Child will be comfortably seated on the portable dental chair in upright position. Plaque will be
removed from the surfaces of the teeth by wiping with cotton gauze. In the first step, 0.25 mL of
the allocated formulation will be dispensed in the dispensing wells. The teeth will be dried using
cotton gauze and isolated. The formulation will be applied and allowed to dry up while maintaining
complete isolation using suction tips. In the second step, 0.25 mL of 5% NaF varnish will be
dispensed in the dispensing wells and will be applied on all the teeth using an applicator tip by
using paint on technique. Adequate isolation will be ensured by the use of suction tips throughout
the application procedure. After varnish application, the patient will be made to sit with the mouth
open for 4 minutes with adequate suction. Thereafter, children will be advised not to rinse or drink
anything for half an hour. Parents will be informed to give liquid and semisolid food items on the
day of varnish application and avoid tooth brushing at the night. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
• Children aged 4-6 years of age in government schools of Chandigarh UT
• Children whose parent/guardian gives informed consent
|
|
| ExclusionCriteria |
| Details |
• History of allergy to fluoride varnish, chlorhexidine and povidone iodine
• Children with debilitating illness/disease
• Children with ongoing orthodontic treatment
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Caries increment |
Baseline, 3 months, 6 months, 1 year and 2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| oral microflora including Mutans streptococci and other salivary parameters |
Baseline, 1 year and 2 years. |
| Tooth remineralization and gingival bleeding scores |
Baseline, 3 months, 6 months, 1 year and 2 years |
| Nutritional status |
Baseline, 3 months, 6 months, 1 year and 2 years |
|
|
Target Sample Size
|
Total Sample Size="660"
Sample Size from India="660"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/09/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Background: Dental caries is a major public health problem worldwide and there exists a relationship with nutritional status, overall growth and development of the child. Recent advancements in preventive dentistry advocate use of an antibacterial agent with topical fluoride to prevent caries incidence effectively. Novelty: Paucity of good quality randomized trials evaluating the added benefit of chlorhexidine or povidone iodine over topical fluoride use alone limits our ability to frame effective caries preventive guidelines for children. The results of this randomized trial will thus help us formulate an effective caries preventive regimen for children. Objectives: To assess and compare the caries preventive effectiveness of antibacterial agent (povidone iodine or chlorhexidine) plus fluoride varnish over fluoride varnish alone among 4–6-year-old children. To correlate the tooth morbidity and nutritional status of the children. Methods: Children will be randomly allocated to one of the three groups (Group 1: 1% chlorhexidine solution followed by 5% fluoride varnish, Group 2: 10% povidone iodine solution followed by 5% fluoride varnish, Group 3: placebo solution followed by 5% fluoride varnish). The three formulations (10% povidone iodine, 1% chlorhexidine and placebo) will be masked indigenously to ensure triple blinding. ICDAS II scores, DIAGNOdent/QLF scores, gingival bleeding index, BMI, and oral microflora including Mutans streptococci will be evaluated at baseline and at follow-ups up to 2 years. Appropriate descriptive and inferential statistics will be applied. Statistical significance is set at p<0.05. Expected outcome: This trial will help evaluate whether semi-annual application of antibacterial agent (povidone iodine or chlorhexidine) along with fluoride varnish is more effective in preventing caries than fluoride varnish application alone among 4–6-year-old children. Caries preventive potential will be assessed through change in dental caries increment and oral microflora in saliva over a two year follow up period. Correlating the BMI and dental caries incidence in children could be useful to determine the effect of tooth morbidity on overall growth of the children and indicate the need for intersectoral coordination for health promotion.
|