| CTRI Number |
CTRI/2021/04/032999 [Registered on: 22/04/2021] Trial Registered Prospectively |
| Last Modified On: |
15/04/2021 |
| 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
|
Comparing the retention of two commercially available pit and fissure sealants |
|
Scientific Title of Study
|
COMPARISON OF CLINICAL EFFICACY OF GLASS IONOMER BASED SEALANT USING ART PROTOCOL AND RESIN BASED SEALANT ON PRIMARY MOLARS IN CHILDREN |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR KIRAN K |
| Designation |
PROFESSOR |
| Affiliation |
The Oxford Dental College |
| Address |
The oxford dental college
Hosur Road
Bommanahalli
Bangalore
The oxford dental college
Hosur Road
Bommanahalli
Bangalore
Bangalore
KARNATAKA
560068
India |
| Phone |
9731196369 |
| Fax |
|
| Email |
drkkiran@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR KIRAN K |
| Designation |
PROFESSOR |
| Affiliation |
The Oxford Dental College |
| Address |
The oxford dental college
Hosur Road, Bommanahalli, Bangalore, 560068
The oxford dental college
Hosur Road, Bommanahalli, Bangalore, 560068
Bangalore
KARNATAKA
560068
India |
| Phone |
9731196369 |
| Fax |
|
| Email |
drkkiran@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
BHARGAVI RATNA VOJJALA |
| Designation |
Post-graduate |
| Affiliation |
The Oxford Dental College |
| Address |
The oxford dental college
Hosur Road, Bommanahalli, Bangalore, 560068
The oxford dental college
Hosur Road, Bommanahalli, Bangalore, 560068
Bangalore
KARNATAKA
560068
India |
| Phone |
9738958042 |
| Fax |
|
| Email |
bhavi.vojjala@gmail.com |
|
|
Source of Monetary or Material Support
|
| the oxford dental college |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| Dr Bhargavi Vojjala |
Department of Pedodontics and Preventive Dentistry, The Oxford Dental College |
Room no. 8, Oxford dental college
10th milestone hosur road,
bommanahalli,bangalore
Bangalore
KARNATAKA |
9738958042
bhavi.vojjala@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee-the oxford dental college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K02||Dental caries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Clinpro |
Applied as pit and fissure sealant
will be evaluated till 1 year
|
| Intervention |
Equia Forte |
applied as pit and fissure sealants
will be evaluated till 1 year |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
1. Otherwise healthy cooperative children with fully erupted primary molars.
2. Deep pits and fissures present in these primary molars. [ICDAS II (International Caries Assessment and Detection System II)4 code 00]
3. Initial occlusal carious lesions involving the pits and fissures of enamel. [ICDAS II code 01]
4. Incipient carious lesion involving enamel. [ICDAS II code 02 and 03]
|
|
| ExclusionCriteria |
| Details |
1. Uncooperative child
2. Children whose parent does not give consent for the study.
3. Children with systemic disorders.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| retention of sealant |
1 month, 6 months, 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| dental caries according to ICDAS II criteria |
1 month, 6 months, 12 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
N/A |
|
Date of First Enrollment (India)
|
29/04/2021 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not applicable
trial not yet started |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Title: Comparison of clinical efficacy of glass ionomer based sealant using ART protocol and resin based sealant on primary molars in children Background and Objectives: Dental caries is a site-specific disease that manifests predominantly in pits and fissures due to their morphology.1 Sealing the pits and fissures for prevention of dental caries has been proven to be highly effective.4 Two predominant types of sealants currently being used are resin based and glass ionomer cement (GIC) sealants. Highly viscous GIC, usually associated with atraumatic restorative treatment (ART), demonstrated increased retention than earlier developed low and medium viscosity GICs. It has also been observed that resin-based sealants show higher retention but are more technique sensitive.6 American Academy of Pediatric Dentistry (AAPD) recommends use of dental sealants for caries prevention in children aged 3 years and older.2 However, there is a paucity of studies on performance of ART sealants in primary molars. Based on the clinical performance of ART sealants on permanent molars, null hypothesis is that the use of high-viscosity GIC as ART sealant will clinically perform comparably in primary molars also. Thus, the aim of the present in-vivo study is to evaluate and compare the clinical efficacy and one year survival rate of resin based composite sealant (Clinpro Sealant, 3M ESPE, USA)with high viscosity glass ionomer (Equia Forte, GC India, India) using ART sealant protocol in primary molars.
Materials and Methods: The design of the study will be clinical, prospective split mouth study. After initial screening, teeth fulfilling the inclusion criteria will randomly be allocated using lottery method to: Group A –ART sealant (Equia Forte, GC India Dental Pte Ltd, Telangana, India)- Encapsulated glass ionomer Group B –Resin based sealant (Clinpro Sealant, 3M ESPE, Minnesota, USA) EquiaForte will be applied on a primary molar in one quadrant and Clinpro Sealant will be applied on the contralateral primary molar of the same dental arch. Materials will be placed as per manufacturers instructions. The follow up examinations will be scheduled at first month, sixth month and twelveth month intervals. At each recall visit, Simonsen’s criteria will be used to check for the retention of sealants using CPI Probe. In case of sealant loss, ICDAS II will be used to check for caries. The data obtained will be subjected to statistical analysis.
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