| CTRI Number |
CTRI/2024/06/068721 [Registered on: 11/06/2024] Trial Registered Prospectively |
| Last Modified On: |
05/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Preventive
Dentistry
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
comparative evaluation of conventional and foldable rubber dam frame used in children aged 6-12 years. |
|
Scientific Title of Study
|
Comparative evaluation of conventional and 3D printed foldable rubber dam frame in children aged 6-12 years.-Randomized Clinical 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 Hetvi Tanna |
| Designation |
Post Graduate Resident |
| Affiliation |
College of Dental Sciences, Amargadh, Bhavnagar, Gujarat. |
| Address |
College of Dental Sciences, Amargadh, Bhavnagar, Gujarat. Tal- shihor, dist-bhavnagar- rajkot highway.
Bhavnagar
GUJARAT
364210
India |
| Phone |
9687855855 |
| Fax |
|
| Email |
hetvitanna855@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vikram Jhamb |
| Designation |
Reader of Department of pediatric and preventive dentistry |
| Affiliation |
College of Dental Sciences, Amargadh, Bhavnagar, Gujarat. |
| Address |
College of Dental Sciences, Amargadh, Bhavnagar, Gujarat. Tal- shihor, dist-bhavnagar- rajkot highway.
Bhavnagar
GUJARAT
364250
India |
| Phone |
9620159058 |
| Fax |
|
| Email |
dr.vikramjhamb@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vikram Jhamb |
| Designation |
Reader of Department of pediatric and preventive dentistry |
| Affiliation |
College of Dental Sciences, Amargadh, Bhavnagar, Gujarat. |
| Address |
College of Dental Sciences, Amargadh, Bhavnagar, Gujarat. Tal- shihor, dist-bhavnagar- rajkot highway.
Bhavnagar
GUJARAT
364250
India |
| Phone |
9620159058 |
| Fax |
|
| Email |
dr.vikramjhamb@gmail.com |
|
|
Source of Monetary or Material Support
|
| College of Dental Sciences, Amargadh, Bhavnagar, Gujarat, India,364210 |
|
|
Primary Sponsor
|
| Name |
Dr Hetvi Tanna |
| Address |
1527/c, sai smruti, mangalya park society, bh. theosophical lodge, opp. to food point restaurant,rupani circle, bhavnaar, gujarat. India 364001 |
| Type of Sponsor |
Other [post graduate student] |
|
|
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 Hetvi Tanna |
College of dental sciences, amargadh, bhavnagar |
Department of Pediatric and Preventive, dentistry. Room no.- 6.
College of Dental
Science and Hospital,
Amargadh Tal- Sihor,
dist- Bhavnagar- Rajkot
Highway
Bhavnagar
GUJARAT
Bhavnagar
GUJARAT |
9687855855
hetvitanna855@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 |
| Healthy Human Volunteers |
dental caries |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
In Group A, Conventional rubber dam frame will be placed in the patients.
|
A conventional rubber dam frame is a metal toothed u shaped device used for salivary isolation of teeth while carrying out the dental treatment procedures which is placed by punching the holes in the rubber dam sheet, followed by securing the sheet on the frame with the help of clamps. |
| Intervention |
In Group B, 3D printed foldable rubber dam frame will be placed in the patients.
|
A modified rubber dam frame is a 3D printed frame designed for kids and adolescent patients having a foldable joint convenience and snap joint to secure the rubber dam sheet between the frame, which is placed by punching the holes in the rubber dam sheet, followed by securing the sheet on the frame by placing clamps over the teeth. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children of both gender.
Dental patients ranging from 6 to 12 years requiring pit and fissure sealant and restorative procedures.
Children and parents who will provide their assent and consent respectively.
|
|
| ExclusionCriteria |
| Details |
Children with special healthcare needs ( Physically disabled and Mentally retarded patients ).
Children with mouth breathing habit.
Children with upper respiratory tract infection.
|
|
|
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 Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
to assess and compare Oxygen saturation
|
before and during the procedure
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to assess and compare cardiac frequency |
before and during the procedure |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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/ Phase 2 |
|
Date of First Enrollment (India)
|
17/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
17/06/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The study will be carried out on 20 children aged from 6 - 12 years of age. A written informed consent will be taken from parents. This will be a randomized clinical trial with parallel design and allocation ratio of 1:1. The recruited children will be randomized with single blind technique and lottery system will be used to assign patients two set of closed envelops will be made mentioning conventional rubber dam frame and 3d printed rubber dam frame in 10 envelops each. After being selected the same envelop will be discarded to provide exact allocation ratio. Groups will be divided into one of the following two groups. Dividing the samples into two groups named as Group A and B. In Group A conventional rubber dam frame will be placed in the patients. In Group B 3d printed foldable rubber dam frame will be placed in the patients. A conventional rubber dam frame will be placed by punching the holes in the rubber dam sheet, followed by securing the sheet on the frame. Rubber dam sheet will be secured in the patient by placing clamps. A modified rubber dam frame will be placed by punching the holes in the rubber dam sheet, followed by securing the sheet on the frame. Rubber dam sheet will be secured in the patient by placing clamps. Oxygen saturation and cardiac frequency with the pulse oximeter will be assessed before and during the rubber dam placement. The statistical analysis will be carried out using SPSS software for Windows (SPSS Inc., Chicago, Ill., USA). |