| CTRI Number |
CTRI/2024/09/073554 [Registered on: 06/09/2024] Trial Registered Prospectively |
| Last Modified On: |
22/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Effectiveness of preventive dental fillings in caries prevention among 7-12 year old school children in Ettumanoor after One-year of follow-up |
|
Scientific Title of Study
|
Effectiveness of pit and fissure sealants in caries prevention among 7-12 year old school children in Ettumanoor : One-year follow-up study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anusree K R |
| Designation |
Junior Resident (MDS) |
| Affiliation |
Govt.Dental College, Kottayam |
| Address |
Department of Public Health Dentistry,Room No:1001
Govt.Dental College
Gandhinagar P.O, Kottayam,
Kerala, India
Kottayam
KERALA
686008
India |
| Phone |
7356707810 |
| Fax |
|
| Email |
anusreekr1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mary Shimi S Gomez |
| Designation |
Assistant Professor |
| Affiliation |
Govt.Dental College ,Kottayam |
| Address |
Department of Public Health Dentistry,Room No:1001
Govt.Dental College
Gandhinagar P.O, Kottayam,
Kerala, India
Kottayam
KERALA
686008
India |
| Phone |
8606436244 |
| Fax |
|
| Email |
maryshimy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anusree K R |
| Designation |
Junior Resident (MDS) |
| Affiliation |
Govt.Dental College,Kottayam |
| Address |
Department of Public Health Dentistry
Govt.Dental College
Gandhinagar P.O, Kottayam,
Kerala, India
Kottayam
KERALA
686008
India |
| Phone |
7356707810 |
| Fax |
|
| Email |
anusreekr1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Public Health Dentistrty
Govt.Dental College
Gandhinagar P.O, Kottayam,
Kerala, India - 686 008 |
|
|
Primary Sponsor
|
| Name |
Dr Anusree K R |
| Address |
Department of Public Health Dentistrty
Govt.Dental College
Gandhinagar P.O, Kottayam,
Kerala, India - 686 008 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Anusree KR |
Government Dental College,Kottayam |
Department of Public Health Dentistry,Room No:1001
Government Dental College
Gandhinagar P.O, Kottayam,
Kerala, India - 686 008
Kottayam
KERALA |
7356707810
anusreekr1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication of decision of the Institutional Ethics Committee(IEC)/Institutional Review Board(IRB) |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Children with Deep pit and fissures |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Oral health education |
Oral health education including oral hygiene instructions and toothbrushing techniques is given to 7-12 year old school children from a selected government aided school in Ettumanoor,Kottayam |
| Intervention |
Pit and fissure sealant application and Oral health education |
Oral health education including oral hygiene instructions and toothbrushing techniques is given to 7-12 year old school children and Pit and fissure sealants(Prevest Denpro PF SealTM) will be applied on to occlusal pits and fissures of permanent molars in children from a selected Government aided school in Ettumanoor,Kottayam |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Study group
Children of specified age attending Government aided schools in Ettumanoor, Kottayam and willing to participate in the study.
Children who will be categorized as high caries risk as per CRA (AAPD)
Children who will be categorized as high caries risk as per CRA (AAPD), those with at least one sound first or second permanent molar (ICDAS II score is 0) or permanent first or second molars with initial caries lesion (ICDAS II score 1-3)
The tooth for sealant placement should be fully erupted, i.e the entire occlusal surface should be exposed into mouth with no overlying tissue operculum and with the distal gingival tissue lying below the height of the distal marginal ridge.
Comparison group
Children of specified age attending other neighbouring Government aided schools in Ettumanoor, Kottayam and willing to participate in the study.
Children who will be categorized as high caries risk as per CRA (AAPD)
|
|
| ExclusionCriteria |
| Details |
Children on any long-term regimen of medication that could affect the salivary flow.
Children undergoing any fixed or removable orthodontic treatment.
Children who have not participated for the 6 months follow up
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sealant retention will be dichotomized as completely retained ( modified Simonsen’s score 0) and not retained (modified Simonson’s score 1-4) |
6 months and 1 year post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Caries incidence on sealed permanent first or second molars and caries increment will be assessed by comparing ICDAS II score at baseline, and at the end of one year for study group and comparison group.
Effectiveness of the sealant program will be assessed in terms of risk difference, relative risk and preventive fraction.
|
6 months and 1 year post intervention |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
25/09/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
DESCRIPTION OF INTERVENTION STUDY GROUP Caries risk assessment will be done using Caries Risk Assessment Tool (CRA) developed by the American Academy of Paediatric Dentistry (AAPD).Calibration of the principal investigator and dental students for recording and diagnosing dental caries using ICDAS II criteria will be done by the faculty in the Department of Public Health Dentistry prior to the data collection. Inter and intra- examiner variability will be tested according to ICDAS II code 0 and ICDAS Code 1-3 combined. Clinical examination will be done by calibrated principal investigator, final year dental undergraduates and postgraduate students. The school children will be categorized as high caries risk based on the caries risk assessment tool.Dental Health education on oral hygiene practices and prevention of dental caries will be provided to all children in the school.Out of those children identified as high risk ,those satisfying the inclusion criteria will be selected for sealant application.Informed consent will be obtained from the parents of selected high risk children for sealant application.Pit and fissure sealant application will be done on the selected teeth of eligible candidates by calibrated investigators. The principal investigator and the dental students will be trained by the faculty at the Department of Public Health dentistry, GDC, Kottayam for standardization of the clinical procedure in sealant placement. Pit and fissure sealant application technique: 1. The teeth will be adequately isolated with cotton rolls. 2. 37% orthophosphoric acid (Prevest DenPro Actino Gel EtchantTM) will be used for etching occlusal pit and fissures for 15 seconds. 3. It will be followed by rinsing the area thoroughly with water for 15 seconds and drying it. 4. Pit and fissure sealants(Prevest Denpro PF SealTM) will be applied on to occlusal pits and fissures of permanent molars according to manufacturer’s instructions. 5. Photopolymerisation using (Woodpecker LED DTM) Light Cure Unit (Light Intensity-1000mW/cm² - 1700mW/cm²) for 20 seconds. 6. Sealants will be evaluated by visual and tactile examination with the help of a mouth mirror and an explorer. 7. Occlusion will be checked with an articulating paper and premature contacts will be relieved. COMPARISON GROUP Caries risk assessment will be recorded using Caries Risk Assessment Tool (CRA) developed by the American Academy of Paediatric Dentistry (AAPD). Clinical examination will be done by calibrated principal investigator, final year dental undergraduates and postgraduate students and diagnosing dental caries using ICDAS II criteria.The school children will be categorized as high caries risk based on the caries risk assessment tool.Dental Health education on oral hygiene practices and prevention of dental caries will be provided to all children. Informed consent will be obtained from parents of high risk children, for participation in 6 month,1year follow up of the study. Follow up visits Study group At follow up visits at 6 months and 1 year, the sealants will be evaluated visually for sealant condition and caries development. Sealant retention will be evaluated using modified Simonsen’s criteria.
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