| CTRI Number |
CTRI/2021/11/037907 [Registered on: 10/11/2021] Trial Registered Prospectively |
| Last Modified On: |
08/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of organic agents on the remineralisation of white spot lesions in primary teeth. |
|
Scientific Title of Study
|
Effectiveness of two novel organic agents on the remineralisation of white spot lesions in primary anterior teeth- A randomised clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Maria Anthonet Sruthi |
| Designation |
Post graduate student |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Department of Pediatric and Preventive Dentistry
Saveetha Dental College and Hospitals
No.162, Poonamallee High Road, Velappanchavadi, Chennai, Tamil Nadu-600077
Chennai
TAMIL NADU
600077
India |
| Phone |
9789986578 |
| Fax |
|
| Email |
antho_mariaspt@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Deepa Gurunathan |
| Designation |
Professor and Head |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Department of Pediatric and Preventive Dentistry
Saveetha Dental College and Hospitals
No.162, Poonamallee High Road, Velappanchavadi, Chennai, Tamil Nadu-600077
Chennai
TAMIL NADU
600077
India |
| Phone |
9994619386 |
| Fax |
|
| Email |
deepag@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Maria Anthonet Sruthi |
| Designation |
Post graduate student |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Department of Pediatric and Preventive Dentistry
Saveetha Dental College and Hospitals
No.162, Poonamallee High Road, Velappanchavadi, Chennai, Tamil Nadu-600077
Chennai
TAMIL NADU
600077
India |
| Phone |
9789986578 |
| Fax |
|
| Email |
antho_mariaspt@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Dental College and Hospitals |
|
|
Primary Sponsor
|
| Name |
Saveetha Dental College |
| Address |
No.162, Poonamallee High Road, Chennai |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Maria Anthonet Sruthi |
Saveetha Dental College and Hospitals |
Department of Pediatric and Preventive Dentistry
No. 162, Poonamallee Hugh Road, Chennai
Thiruvallur
TAMIL NADU |
9789986578
antho_mariaspt@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Nil |
| Patients |
(1) ICD-10 Condition: K026||Dental caries on smooth surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Grape seed extract |
Grape seed extract contains proanthocyanidin, known to increase collagen cross-links. Collagen serves as a substrate for remineralisation process.
Duration: 3 months |
| Comparator Agent |
Sodium fluoride |
Sodium fluoride improves microhardness of demineralized enamel and dentin.
Duration: 3 months |
| Intervention |
Theobromine extract |
Theobromine is an alkaloid from cacao plant. In the presence of calcium and phosphate, theobromine forms hydroxyapatite crystals of increased size which strengthen the enamel.
Duration: 3 months |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
White spot lesions on the labial surface of at least one primary maxillary anterior teeth |
|
| ExclusionCriteria |
| Details |
Cavitated lesions on primary maxillary anterior teeth
Developmental enamel alterations
Children with systemic diseases
Children allergic to any fruits, seeds,nuts
Children previously exposed to fluoride |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Remineralisation/ decrease in dimensions of white spot lesions on primary maxillary anterior teeth |
1 and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| dmft score |
1 and 3 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2 |
|
Date of First Enrollment (India)
|
20/11/2021 |
| 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="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
White spot lesions are characterized by subsurface demineralization with an intact surface layer of enamel. These lesions form the foundation of caries and are most often unnoticed or neglected by guardians/ parents of preschool children. These lesions can precipitate a rampant attack of dental caries on short notice in children. This invariably affects the quality of life of children as it may lead to pain and infection. The scope of this study focuses on the early detection of such incipient lesions thereby deflecting its consequences by using preventive agents for remineralization. With the world currently directed towards organic sources and remedies, natural substances such as plant/fruit extracts as remineralizing agents would be more feasible, safe and acceptable by the parent/ patient. |