| CTRI Number |
CTRI/2024/10/074940 [Registered on: 08/10/2024] Trial Registered Prospectively |
| Last Modified On: |
03/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two different types of materials in preventing dental caries among 7-10 year old school children |
|
Scientific Title of Study
|
Retention and caries preventive effect of glass ionomer and resin based sealants among 7-10 years old schoolchildren: An 18 month randomized controlled trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KONATHAM REENA EVANGELINE |
| Designation |
post graduate |
| Affiliation |
Anil neerukonda institute of dental sciences |
| Address |
Room no.5, Department of public health dentistry,Anil neerukonda institute of dental sciences,sangivalasa, visakhapatnam.
Visakhapatnam
ANDHRA PRADESH
531162
India |
| Phone |
7396098698 |
| Fax |
|
| Email |
drreenaevangeline@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr L Vamsi krishna reddy |
| Designation |
professor and head of the department |
| Affiliation |
Anil neerukonda institute of dental sciences |
| Address |
Room no.5, Department of public health dentistry,Anil neerukonda institute of dental sciences,sangivalasa, visakhapatnam.
Room no.5, Department of public health dentistry,Anil neerukonda institute of dental sciences,sangivalasa, visakhapatnam.
Visakhapatnam
ANDHRA PRADESH
531162
India |
| Phone |
9908200033 |
| Fax |
|
| Email |
principal.anids@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
KONATHAM REENA EVANGELINE |
| Designation |
post graduate student |
| Affiliation |
Anil neerukonda institute of dental sciences |
| Address |
Room no.5, Department of public health dentistry,Anil neerukonda institute of dental sciences,sangivalasa, visakhapatnam.
Room no.5, Department of public health dentistry,Anil neerukonda institute of dental sciences,sangivalasa, visakhapatnam.
Visakhapatnam
ANDHRA PRADESH
531162
India |
| Phone |
07396098698 |
| Fax |
|
| Email |
drreenaevangeline@gmail.com |
|
|
Source of Monetary or Material Support
|
| Anil neerukonda institute of dental sciences |
|
|
Primary Sponsor
|
| Name |
Anil neerukonda institue of dental sciences |
| Address |
Room no.5, department of public health dentistry, Anil neerukonda institute of dental sciences,sangivalasa, visakhapatnam. |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr L Vamsi krishna reddy |
room no.5, department of public health dentistry, anil neerukonda institute of dental sciences,sangivalsa, visakhapatnam. |
| NIL |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| reena evangeline konatham |
Tertiary care hospital |
Room no.5,department of public health dentistry,Anil neerukonda institute of dental sciences, sangivalsa, visakhapatnam.
Visakhapatnam
ANDHRA PRADESH |
7396098698
drreenaevangeline@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Anil neerukonda institute of dental sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Screening intervention |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
caries preventive effect and retention rate |
caries preventive effect of glass ionomer and resin based sealant in spilt mouth randomized clinical trial among 7-10 year school going children |
| Comparator Agent |
Resin based sealant |
Retention rate of glass ionomer pit and fissure sealant and resin based sealant application in split-mouth randomized clinical trial among 7-10 year school children . |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1) Children parents who had given consent.
2)Children whose first permanent molars consists of deep fissures with 0 & 1 scores,according to ICDAS classification contralaterally
|
|
| ExclusionCriteria |
| Details |
)Children with special needs and uncooperative children.
2) Children with developmental anomalies like enamel hypoplasia , dental fluorosis
3)Children with bruxism or para functional habits.
4)Malocclusion with spacing, rotations and crowding.
5)Children whose teeth have insufficient isolation and thus cannot be treated with the specified application technique.
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Retention rates |
3 months, 6 months, 18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| caries preventive effect |
3 months, 6 months, 18 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
15/10/2024 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim of the study is to
compare the retention and caries preventive effect of conventional glass
ionomer fissure sealants and resin based fissure sealants among 7-10 years age
school children in govt.schools of
Bheemunipatnam mandal. A randomized controlled
clinical trial using a split-mouth technique will be carried out among 7-10 yrs
aged school children in governmentschools of Bheemunipatnam mandal. Prior
permission will be taken from the principals of schools.Written informed
consent will be sent to the parents/guardians of children who were willing to
participate, explaining the benefits and
risks involved.The principal
investigator will perform the clinical examination of every participant and the
contralateral first permanent mandibular molar tooth will be sealed with two
different types of sealants.On one side of the mouth, Glass ionomer sealant
and on another side resin based sealant
will be applied according to the manufacturer’s instructions. Retention
of both the conventional and resin based sealants will be evaluated and
compared by the examiner at 3,6, 12 and 18 months interval. |