| CTRI Number |
CTRI/2022/08/044891 [Registered on: 24/08/2022] Trial Registered Prospectively |
| Last Modified On: |
23/08/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
comparison of three different dental sealants to prevent dental decay |
|
Scientific Title of Study
|
Comparative evaluation of retention and caries incidence of three different pit and fissure sealants using “CCC†evaluation system- A Double Blinded Randomized Controlled Clinical Trials
|
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hariprasath Nagarajan |
| Designation |
Post graduate student - II year, Department of public health dentistry |
| Affiliation |
Saveetha dental college and hospital |
| Address |
Saveetha dental college, 162, PH road, velappanchavadi, chennai
Chennai TAMIL NADU 639006 India |
| Phone |
8056720879 |
| Fax |
|
| Email |
drharithedentist@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DrJayashree Prabakar |
| Designation |
Reader, Department of public health dentistry |
| Affiliation |
Saveetha dental college and hospital |
| Address |
Saveetha dental college, 162, PH road, velappanchavadi, chennai
Chennai TAMIL NADU 600077 India |
| Phone |
7904181675 |
| Fax |
|
| Email |
shrijaya2009@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Hariprasath Nagarajan |
| Designation |
Post graduate student - II year, Department of public health dentistry |
| Affiliation |
Saveetha dental college and hospital |
| Address |
Saveetha dental college, 162, PH road, velappanchavadi, chennai
Chennai TAMIL NADU 600077 India |
| Phone |
8056720879 |
| Fax |
|
| Email |
drharithedentist@gmail.com |
|
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Source of Monetary or Material Support
|
| Saveetha dental college and hospital, Chennai |
|
|
Primary Sponsor
|
| Name |
Dr Hariprasath Nagarajan |
| Address |
Saveetha dental college and hospital, 162-PH road, velappanchavadi, Chennai |
| Type of Sponsor |
Other [self] |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Mr Augustin chelladurai |
Joy bell matriculation school |
Joy bell matriculation school, No.14 James street extension, Poonamallee, Thiruvallur Thiruvallur TAMIL NADU |
9150750874
joybellmatric@gmail.com |
| Xavier Kumar |
Popli Raja Government higher secondary school |
Surapet Main Rd, Kathirvedu, Puzhal, Chennai-600066 Chennai TAMIL NADU |
9884507099
drharithedentist@gmail.com |
| Mrs Kavitha |
Public Union Middle School, |
village- Mappedu
Block Name- Kadambathur
District - Thiruvallur
State- Tamil Nadu Thiruvallur TAMIL NADU |
9655787303
drharithedentist@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Institutional human ethics committee |
Approved |
| Joy bell matriculation school, Poonamallee |
No Objection Certificate |
| Popili Raja government highschool |
No Objection Certificate |
| Public union middle school, samathuvapuram |
No Objection Certificate |
|
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Regulatory Clearance Status from DCGI
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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 |
| Intervention |
IONOSEAL |
Ionoseal® is a light-curing glass ionomer composite cement for linings, extended fissure sealing and treatment of smaller lesions.follow up for 1 year |
| Comparator Agent |
ULTRASEAL XT HYDRO |
UltraSeal XT hydro hydrophilic pit and fissure sealant is a light-cured, radiopaque, fluoride-releasing composite sealant.follow up for 1 year |
| Intervention |
VOCO twinky star flow (compomer) |
Compomers are recently introduced products marketed as a new class of dental materials. These materials are said to provide the combined benefits of composites (the "comp" in their name) and glass ionomers ("omer"). follow up for 1 year |
|
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Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 12-15 years old who were apparently healthy without any known history of systemic illness, whose parents consented for their participation and teeth with ICDAS scoring 0,1 and 2 are the inclusion of the study |
|
| ExclusionCriteria |
| Details |
Children with suspected caries, enamel hypoplasia, or dental fluorosis and children who were uncooperative or refused dental treatment. Children who developed any complications during the study period were excluded from the study. |
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
CCC evaluation system -
Discolouration, retention rate and coverage |
3rd,6th,9th and 12th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| color change in the dental sealant, coverage of the sealant and secondaries caries at 3rd, 6th, 9th and 12th month |
1 year |
|
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Target Sample Size
|
Total Sample Size="246" Sample Size from India="246"
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 4 |
|
Date of First Enrollment (India)
|
16/02/2023 |
| 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 |
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Publication Details
|
NIL |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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|
Brief Summary
|
The dental council of India National Oral Health Survey from 2002-2003 revealed the prevalence of dental caries is 49.8% with a mean decayed, missing and filled teeth (DMFT) index of 2.5 among 12 years old individuals and 3.4 among the 15 years old individuals. With this picture in mind, the public health dentist has a moral obligation to spread awareness on oral diseases and to promote oral health ultimately leading to a better quality of life. In alignment with the principle of “prevention is better than cureâ€, in depth research on pit and fissure sealants can prove to be a valuable tool in reduction of mean DMFT rate in a community. In consequence, a double blinded randomized controlled clinical trial will be done using three different pit and fissure sealant among 12 to 15 year old young adolescents in rural Tamil Nadu with the follow up of 1 year where the evaluation will be done every 3 months interval. A total of 246 participants were randomly allocated to three groups (n=82). VOCO twinky star flow (Compomer) , Ionoseal (Flowable GIC), and Ultraseal XT hydro (Hydrophilic sealant) are the three different types of sealants that will be used in the trial.. A single operator will perform the sealant application in the allocated tooth during the single visit. The followup examination and evaluation of the pit and fissure sealant will be performed by the primary investigator who was blinded to interventional groups. At 3, 6, 9 and 12 month intervals, the sealants will be evaluated using the CCC evaluation system. |