| CTRI Number |
CTRI/2025/08/092955 [Registered on: 13/08/2025] Trial Registered Prospectively |
| Last Modified On: |
12/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Checking three different isolation technique in children during root canal procedure of the milk tooth. |
|
Scientific Title of Study
|
Evaluation of Child’s behaviour, Anxiety level, Operators convenience during dental care procedure with Rubber dam, Mini dam , Optra dam isolation technique.
– A Randomized Control 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 |
Dr Sherin A |
| Designation |
Pg Student |
| Affiliation |
Karpaga Vinayaga Institute Of Dental Sciences |
| Address |
karpaga vinayaga institute of dental sciences,
palaynoor post madhuranthagam kancheepuram district
Room No:8,Department of Pedodontics , 4th floor .
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
8124420360 |
| Fax |
|
| Email |
sherinarul0104@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Sunil Kumar |
| Designation |
Associate Professor |
| Affiliation |
Karpaga Vinayaga Institute Of Dental Sciences |
| Address |
Karpaga Vinayaga Institute Of Dental Sciences
GST road Chinnakolambakkam Madhuranthagam
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
9962783848 |
| Fax |
|
| Email |
sunilmsk85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sherin A |
| Designation |
pg student |
| Affiliation |
Karpaga Vinayaga Institute Of Dental Sciences |
| Address |
karpaga vinayaga institute of dental sciences,
palaynoor post madhuranthagam kancheepuram district
Room No:8,Department of Pedodontics , 4th floor .
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
8124420360 |
| Fax |
|
| Email |
sherinarul0104@gmail.com |
|
|
Source of Monetary or Material Support
|
| karpaga vinayaga institute of dental sciences,
Room No:8,Department of Pedodontics , 4th floor
palaynoor post madhuranthagam kancheepuram district
603308 |
|
|
Primary Sponsor
|
| Name |
Dr Sherin A |
| Address |
karpaga vinayaga institute of dental sciences,
palaynoor post madhuranthagam kancheepuram district
Room No:8,Department of Pedodontics , 4th floor .
chennai 600045 |
| 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 Sherin A |
Karpaga Vinayaga Institute of Dental Sciences |
Karpaga Vinayaga institute Of Dental Sciences
Department Of Paediatric And Preventive Dentistry .Room no:8
GST road chinnakolambakkam palyanoor post chengalpattu district
Kanceepuram
Kancheepuram
TAMIL NADU |
08124420360
sherinarul0104@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Mini dam , Optra dam |
The procedure will be explained to the participants verbally and using audio visual records. Prior to placement of mini dam,optra dam isolation technique 2% lignocaine local anesthesia is given. Anxiety level, child’s behaviour are assessed at baseline and during the placement of using mini dam, optra dam using animated visual anxiety rating scale and modified Frankel behaviour rating scale respectively and recorded .Operators convenience during dental care procedure is calculated by recording time from baseline and during the placement of mini dam ,optra dam using stop clock. |
| Intervention |
Rubber Dam |
duration of intervention will be from baseline to the placement of dam.The procedure will be explained to the participants verbally and using audio visual records. Prior to placement of rubber dam isolation technique 2% lignocaine local anesthesia is given. Anxiety level, child’s behaviour are assessed at baseline and during the placement of using
rubber dam using animated visual anxiety rating scale and modified Frankel behaviour rating scale respectively and recorded .Operators convenience during dental care procedure is calculated by recording time from baseline and during the placement of rubber dam using stop clock.
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.Adequate tooth structure.
2.Patient who are willing to be a part of the study .
3.Children between 6-12yrs of age .
4.Patient with multiple sitting procedures.
|
|
| ExclusionCriteria |
| Details |
1.Unrestorable teeth, partially erupted tooth
2.Children with special health care needs.
3.Patient with systemic illness.
4.Extremely malpositioned teeth.
5.Patient with latex allergy .
6.Periodontally weakened tooth .
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduced anxiety, good cooperation of child’s behaviour in Optra dam isolation technique. |
these parameters will be assessed at baseline and after placement of each dams. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| less time consuming in Optra dam isolation technique when compared to mini dam,Optra dam. |
will be assessed at the baseline & after placement of each dam |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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 1 |
|
Date of First Enrollment (India)
|
01/10/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Participants will be selected from the patient reporting to pedodontics department for the restoration of teeth . Participants will be divided into three group by inclusion and exclusion criteria . using coin toss method individuals will be randomly divided into three group and totally 75 participants will be be taken into account.group1(25):rubber dam , group2(25):mini dam,group3(25): Optra dam . The procedure will be explained to the participants verbally and using audiovisual aids . prior to placement of three isolation technique two percent lignocaine local anesthesia is given. then anxiety level will be assessed during baseline and during the placement of rubber dam, mini dam, optra dam, using animated visual anxiety rating scale , ghanashyam prasad M et al ,2022 .Childs behaviour will be assessed using modified frankle behaviour rating scale, Machen and Johnson,1991. Operators convenience will be assessed by stopwatch. |