| CTRI Number |
CTRI/2021/09/036409 [Registered on: 10/09/2021] Trial Registered Prospectively |
| Last Modified On: |
09/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Retention of pit and fissure sealants placed with Enamel
Deproteinization pre-treatment among adolescents- RCT |
|
Scientific Title of Study
|
Evaluation of retention of pit and fissure sealants placed with and without Enamel
Deproteinization pre-treatment among adolescents- A Split mouth Randomized Controlled
Trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr SWATISHREE SAHOO |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
SUDHA RUSTAGI COLLEGE OF DENTAL SCIENCES AND RESEARCH |
| Address |
ROOM N0- 3,
DEPARTMENT OF PUBLIC HEALTH DENTISTRY
SUDHA RUSTAGI COLLEGE OF DENTAL SCIENCES AND RESEARCH
FARIDABAD
HARYANA
ROOM NO- 3
DEPARTMENT OF PUBLIC HEALTH DENTISTRY
SUDHA RUSTAGI COLLEGE OF DENTAL SCIENCES AND RESEARCH
FARIDABAD
HARYANA
Faridabad
HARYANA
121002
India |
| Phone |
9439707337 |
| Fax |
|
| Email |
sahoo.swatishree7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr CHARU MOHAN MARYA |
| Designation |
HEAD OF THE DEPARTMENT |
| Affiliation |
SUDHA RUSTAGI COLLEGE OF DENTAL SCIENCES AND RESEARCH |
| Address |
ROOM NO- 3
DEPARTMENT OF PUBLIC HEALTH DENTISTRY
SUDHA RUSTAGI COLLEGE OF DENTAL SCIENCES AND RESEARCH
FARIDABAD
HARYANA
ROOM NO- 3
DEPARTMENT OF PUBLIC HEALTH DENTISTRY
SUDHA RUSTAGI COLLEGE OF DENTAL SCIENCES AND RESEARCH
FARIDABAD
HARYANA
Faridabad
HARYANA
121002
India |
| Phone |
9811144408 |
| Fax |
|
| Email |
maryacm@yahoo.co.uk |
|
Details of Contact Person
Public Query
|
| Name |
Dr SWATISHREE SAHOO |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
SUDHA RUSTAGI COLLEGE OF DENTAL SCIENCES AND RESEARCH |
| Address |
ROOM NO- 3
DEPARTMENT OF PUBLIC HEALTH DENTISTRY
SUDHA RUSTAGI COLLEGE OF DENTAL SCIENCES AND RESEARCH
FARIDABAD
HARYANA
ROOM NO- 3
DEPARTMENT OF PUBLIC HEALTH DENTISTRY
SUDHA RUSTAGI COLLEGE OF DENTAL SCIENCES AND RESEARCH
FARIDABAD
HARYANA
Faridabad
HARYANA
121002
India |
| Phone |
9439707337 |
| Fax |
|
| Email |
sahoo.swatishree7@gmail.com |
|
|
Source of Monetary or Material Support
|
| SELF SPONSOR
Study will be conducted at: Department no. 3
Sudha Rustagi College of Dental Sciences and Research |
|
|
Primary Sponsor
|
| Name |
SELF FUNDED Dr SWATISHREE SAHOO |
| Address |
DEPARTMENT OF PUBLIC HEALTH DENTSITRY
DEPARTMENT NO- 3
SUDHA RUSTAGI COLLEGE OF DENTAL SCIENCES AND RESEARCH
FARIDABAD
HARYANA |
| Type of Sponsor |
Other [SELF FUNDED] |
|
|
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 SWATISHREE SAHOO |
DEPARTMENT OF PUBLIC HEALTH DENTISTRY |
DEPARTMENT NO- 3
SUDHA RUSTAGI COLLEGE OF DENTAL SCIENCES AND RESEARCH
FARIDABAD
Faridabad
HARYANA |
9439707337
sahoo.swatishree7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE,SUDHA RUSTAGI COLLEGE OF DENTAL SCIENCES AND RESEARCH |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
SYSTEMICALLY HEALTHY |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
PIT AND FISSURE SEALANT WITH ENAMEL DEPROTEINIZATION PRE-TREATMENT |
DURATION OF THE STUDY- 6 MONTHS
1) Isolation- Complete isolation with rubber dam will be assured before sealant placement.
2) Prophylaxis- The occlusal surfaces of the selected teeth will be cleaned with a rotary brush and fluoride-free pumice, then washed with air water spray and dried with oil-free air stream.
3) Enamel deproteinization with 5.25% NaOCl for 1 minute will be done.
4) Surface conditioning- Acid etching will be performed using 37% phosphoric acid gel for 15 seconds as instructed by the manufacturer. The etchant will be gently moved on the occlusal surfaces by soft micro brush to enhance the penetration ability of the etchant into the fissure. Etchant will be copiously washed by water for 30 seconds and air-dried frosty appearance will be appreciated.
5) Sealant application- The sealant will be applied starting from the maximum depth of the central fissure up towards the two thirds of cusp height and cured with light source according to the manufacturer s instructions. After the sealants will be placed, the rubber dam will be removed and the occlusion will be checked with an articulating paper. Any premature contact will be removed.
6) Post-operative instructions- Do not eat or drink for 30 minutes following application.
|
| Comparator Agent |
PIT AND FISSURE SEALANT WITHOUT ENAMEL DEPROTEINIZATION |
WITHOUT ENAMEL DEPROTEINIZATION |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Patient related criteria:
1) Cooperative adolescents aged from 15-18 years old.
2) Healthy adolescents with no history of previous systematic diseases that can affect their oral
health.
3) Adolescents with Dean Fluorosis index of 0,1 and 2
Tooth related criteria:
1) Both mandibular second permanent molars which are fully erupted and having deep narrow
central fissures and supplemental grooves.
2) Second permanent molars’ occlusal surfaces with scores of 0, 1, or 2 according to the
International Caries Detection and Assessment System II (ICDAS II)
3) Teeth selected is in contact with the antagonist tooth
4) Teeth reported as sensitive to any type of stimulus were also excluded |
|
| ExclusionCriteria |
| Details |
1) Adolescents with known allergy to any of the resins used,
2) Adolescents having proximal caries, clinically detectable caries, developmental
defects or hypoplastic teeth.
3) Any professionally applied caries preventive measures carried out in the last two years.
4) Adolescents with bruxism or malocclusion
5) Adolescents with mental and/or physical disorders
6) Adolescents with residence outside of the city of Faridabad, insufficient address for
follow-up, or unwillingness to return for follow-up |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. RETENTION
2. SEALANT EVALUATION
3. SEALANT EVALUATION TIME |
1 WEEK
1 MONTH
3 MONTHS
6 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Acceptance of both the procedures by the same patient will be recorded using
VAS after sealant application |
ONLY AT BASELINE |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
10/09/2021 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
TITLE- Evaluation of retention of pit and fissure sealants placed with and without Enamel Deproteinization pre-treatment among adolescents- A Split mouth Randomized Controlled Trial.RESEARCH QUESTION Is there any difference in the six months retention rate of Resin based, light cure pit and fissure sealant when pre-treated with enamel deproteinization as compared to that when applied without any pre-treatment among adolescents aged 15-18 years? The question is given in the PICOT format as follows: P (POPULATION): 15-18years old adolescents. I (INTERVENTION): Pit and fissure sealant application with enamel deproteinization C (COMPARISON): Pit and fissure sealant application without enamel deproteinization O (OUTCOME): Retention rate T (TIME): Six Months (S- STUDY DESIGN): Randomized controlled clinical trial- a split mouth technique
AIM: To compare the six months retention rate of Resin based, light cure pit and fissure sealant applied with and without Enamel Deproteinization pretreatment among 15-18 years old adolescents.
OBJECTIVES: 1. To evaluate retention rate of Resin based, light cure pit and fissure sealant applied with Enamel Deproteinization pre-treatment at one week, one month, three months and six months. 2. To evaluate retention rate of Resin based, light cure pit and fissure sealant applied without Enamel Deproteinization pre-treatment at one week, one month, three months and six months. 3. To compare retention rate of Resin based, light cure pit and fissure sealant applied with and without Enamel Deproteinization pre-treatment at one week, one month, three months and six months. 4. To compare application time of Resin based, light cure pit and fissure sealants with and without Enamel Deproteinization pre-treatment at first visit only. 5. To evaluate and compare the pain/ discomfort tolerance using a Visual Analogue Scale (VAS) during the application procedure at first visit only. |