| CTRI Number |
CTRI/2020/03/023684 [Registered on: 02/03/2020] Trial Registered Prospectively |
| Last Modified On: |
22/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A study to compare how long cement retains in the upper and lower back teeth when placed using air abrasion and acid application techniques |
|
Scientific Title of Study
|
In Vivo retention rates of pit and fissure sealants placed on occlusal surface of first permanent molars treated with dental air abrasion and acid etching
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bodike Deepika |
| Designation |
Post Graduate Student |
| Affiliation |
Vishnu Dental College, Bhimavaram |
| Address |
Room no.5,Department of pedodontics and preventive dentistry,
Vishnu Dental College, Vishnupur,Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
8500285149 |
| Fax |
08816250894 |
| Email |
deepu.bodike92@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinay C |
| Designation |
Professor |
| Affiliation |
Vishnu Dental College, Bhimavaram |
| Address |
Room no.5,Department of pedodontics and preventive dentistry,
Vishnu Dental College, Vishnupur,Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9666404455 |
| Fax |
08816250894 |
| Email |
vinaychandrappa@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinay C |
| Designation |
Professor |
| Affiliation |
Vishnu Dental College, Bhimavaram |
| Address |
Room no.5,Department of pedodontics and preventive dentistry,
Vishnu Dental College, Vishnupur,Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9666404455 |
| Fax |
08816250894 |
| Email |
vinaychandrappa@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Vishnu dental college,
Vishnupur,Bhimavaram,West Godavari,Andhra Pradesh,534202. |
|
|
Primary Sponsor
|
| Name |
Bodike Deepika |
| Address |
MDS Post graduate Student,
Department of Pedodontics & Preventive dentistry,
Vishnu Dental College, Vishnupur,Bhimavaram,West Godavari,Andhra Pradesh,534202. |
| Type of Sponsor |
Other [Postgraduate student] |
|
|
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 Bodike Deepika |
Vishnu dental college |
Vishnupur,Bhimavaram,Andhra Pradesh,534202.
West Godavari
ANDHRA PRADESH |
8500285149
08816250894
deepu.bodike92@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vishnu Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K025||Dental caries on pit and fissure surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Acid etching |
37% Phosphoric acid D-Tech Etchant gel |
| Intervention |
Air abrasion |
Aqua care dental air abrasion unit with 29 microns aluminium powder particles |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
1.Children between 6-9 years of age
2.Completely erupted caries free maxillary and mandibular permanent first molars.
3.Absence of restorations or pit and fissure sealants on teeth.
4.Cooperative child and consent for treatment.
5.Children willing for follow up of 6,12,18 months.
|
|
| ExclusionCriteria |
| Details |
1.Medically compromised patients with history of respiratory disease, mental and physically
challenged patients.
2.Children allergic to latex.
3.Children participating in other studies.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Evaluation of retention rates of sealants
|
1.Retention rates-6,12,18 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.Tonn and Ryge scoring criteria. |
1.Tonn and Ryge scoring criteria - 6,12,18 Months. |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
02/03/2020 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is randomized cross over control trial to compare the retention rates of pit and fissure sealants placed using dental air abrasion and acid etching in children with in the age group of 6-9 years with pit and fissure caries on occlusal surfaces of first permanent molars that is conducted in vishnu dental college ,Bhimavaram. The outcome measures will be to assess the retention rates of pit and fissure sealant on first permanent molars at 6,12,18 months. |