| CTRI Number |
CTRI/2025/06/088724 [Registered on: 12/06/2025] Trial Registered Prospectively |
| Last Modified On: |
12/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Comparing Child anxiety and behaviour during Optra dam and rubber dam use. |
|
Scientific Title of Study
|
Evaluation of Childs
Behavior and Anxiety level during application of Optra Dam and Rubber Dam Isolation in Children: 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 |
Farheen Sultan |
| Designation |
Senior Resident |
| Affiliation |
Maulana Azad Institute of Dental Sciences |
| Address |
5th floor , Department of Pediatric and Preventive Dentistry, Maulana Azad Institute of Dental Sciences.
New Delhi
DELHI
110002
India |
| Phone |
9650286785 |
| Fax |
|
| Email |
drfarheensultan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Farheen Sultan |
| Designation |
Senior Resident |
| Affiliation |
Maulana Azad Institute of Dental Sciences |
| Address |
5th floor , Department of Pediatric and Preventive Dentistry, Maulana Azad Institute of Dental Sciences.
New Delhi
DELHI
110002
India |
| Phone |
9650286785 |
| Fax |
|
| Email |
drfarheensultan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Farheen Sultan |
| Designation |
Senior Resident |
| Affiliation |
Maulana Azad Institute of Dental Sciences |
| Address |
5th floor , Department of Pediatric and Preventive Dentistry, Maulana Azad Institute of Dental Sciences.
New Delhi
DELHI
110002
India |
| Phone |
9650286785 |
| Fax |
|
| Email |
drfarheensultan@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Maulana Azad Institute of Dental Sciences Self |
| Address |
5th floor, Department of Pediatric and Preventive Dentistry , Maulana Azad Institute of Dental Sciences, BSZ Marg , MAMC Complex, Delhi 110002 |
| Type of Sponsor |
Government medical college |
|
|
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 Farheen Sultan |
Maulana Azad Institute of Dental Sciences |
Room no 507,5th Floor,Department of Pediatric and Preventive Dentistry
Central
DELHI |
9650286785
drfarheensultan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAIDS Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
Optra Dam Isolation |
OptraDam Plus is a flexible, three-dimensional rubber dam used in dentistry for isolating the treatment area, providing a dry and controlled environment |
| Comparator Agent |
Rubber Dam Isolation |
Rubber dam isolation uses a thin latex or non-latex sheet to isolate teeth during dental procedures. Its a method of providing a dry, clean, and isolated field, improving visibility and access for the dentist. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Children of age 3 to 5 years
Children with First dental visit.
Children with Frankl III and IV rating
Children with at least two teeth with Class I caries in primary dentition.
Apparently healthy children without any systemic disease.
|
|
| ExclusionCriteria |
| Details |
Children with Frankl I and II rating
Children having dentoalveolar abscess or dental trauma
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Child’s Behaviour before application and after removal of Optra Dam and Rubber Dam isolation at First visit.
2.Child’s Behaviour before application and after removal of Optra Dam and Rubber Dam isolation at 1 week interval.
3.Child’s Anxiety level before application and after removal of Optra Dam and Rubber Dam isolation at First visit.
4.Child’s Anxiety level before application and after removal of Optra Dam and Rubber Dam isolation at 1 week interval
|
At Baseline , and at 1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Maternal Anxiety level |
Maternal Anxiety level
Time Points - 4 Months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/06/2025 |
| Date of Study Completion (India) |
29/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
29/08/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Sent the article for publication in IJPD on 12th September 2025 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The Rubber Dam system not only offers isolation but also has several additional advantages, such as protection from aspiration, provision of good access/visibility, protection of the soft tissue, and minimization of aerosol-related cross-infections. It can also alleviate the fear of intrusion, as while the rubber dam is in place, child patients perceive that the treatment is taking place outside of their mouth. However, the application of this system is difficult in younger children and may induce anxiety. Nonetheless, Optra Dam is the latest addition to the rubber dam family. It is even more flexible and enables the operator to position it easily and appropriately into the oral cavity of the patient. This may reduce the anxiety associated with the placement of Optra Dam. Hence, this study is planned to evaluate the benefits of New Isolation system in younger children. |