| CTRI Number |
CTRI/2025/09/095500 [Registered on: 30/09/2025] Trial Registered Prospectively |
| Last Modified On: |
26/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry
Other (Specify) [ISOLATION DEVICE] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Dental isolation in children: comparing Mr Thirsty one-step suction with rubber dam to keep the mouth dry during treatment |
|
Scientific Title of Study
|
Mr.thirsty one step suction vs Rubber dam : a clinical trial in pediatric dental isolation technique |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sakshi Joshi |
| Designation |
MDS |
| Affiliation |
peoples collede of dental sciences and research centre |
| Address |
peoples college of dental sciences and research center
peoples college of dental sciences and research center
ayodhya bypass road,bhanpur
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9689680947 |
| Fax |
|
| Email |
sakshijoshi200511@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sakshi Joshi |
| Designation |
MDS |
| Affiliation |
peoples collede of dental sciences and research centre |
| Address |
peoples college of dental sciences and research center
peoples college of dental sciences and research center
ayodhya bypass road,bhanpur
MADHYA PRADESH
462037
India |
| Phone |
9689680947 |
| Fax |
|
| Email |
sakshijoshi200511@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sakshi Joshi |
| Designation |
MDS |
| Affiliation |
peoples collede of dental sciences and research centre |
| Address |
peoples college of dental sciences and research center
peoples college of dental sciences and research center
ayodhya bypass road,bhanpur
MADHYA PRADESH
462037
India |
| Phone |
9689680947 |
| Fax |
|
| Email |
sakshijoshi200511@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Peoples College of dental sciences and research centre |
| Address |
Department of pediatric and Preventive Dentistry, Peoples college of Dental Sciences and Research Center, Bhopal, 462037 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrSakshi Satish Joshi |
Peoples College of Dental Sciences and Research Center,Bhanpur,Bhopal |
S-9,Department of Pediatric and Preventive Dentistry Peoples College of Dental Sciences and Research Center,Bhanpur,Bhopal
Bhopal
MADHYA PRADESH |
09689680947
sakshijoshi200511@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PCDS ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MR.THISRTY ONE STEP SUCTION |
Mr. Thirsty One-Step Suction is a dental device used to keep the mouth dry and provide isolation during dental treatment. In this study, children will receive dental care using the Mr. Thirsty One-Step Suction device, which is considered the gold standard for isolation. Each isolation procedure will last for the full dental treatment session, typically about 20 to 40 minutes, depending on the procedure. |
| Comparator Agent |
RUBBER DAM |
Rubber dam placement is considered the gold standard method for isolating teeth during dental treatment. In this study, children will receive dental care using a rubber dam to keep the mouth dry. Each isolation procedure is expected to last for the entire dental treatment session, which will typically range from approximately 20 to 40 minutes, depending on the type of procedure performed. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Children whose guardian & parent provide their consent
|
|
| ExclusionCriteria |
| Details |
Children with any systemic disease
Uncooperative Children
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome of this study is to compare the efficiency and patient acceptance of two isolation techniques in children—Mr. Thirsty One-Step Suction versus the traditional rubber dam. |
4 Weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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 2 |
|
Date of First Enrollment (India)
|
15/10/2025 |
| 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="0"
Months="1"
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
|
This clinical trial evaluates two methods used to keep a child’s mouth dry and comfortable during dental treatment: the traditional rubber dam and the Mr. Thirsty One-Step suction device. Ten children aged 6–14 years, each needing fillings on both sides of the mouth, will receive treatment using rubber dam isolation on one side and Mr. Thirsty isolation on the other (split-mouth design). For each technique, the dentist will record placement, treatment, and removal times with a stopwatch to assess efficiency. After both procedures, children will give feedback on comfort and preference. Data will be analyzed statistically to determine which method offers shorter chair-side time and better patient acceptance. The study aims to provide evidence on whether the simplified Mr. Thirsty system can be an effective, child-friendly alternative to the gold-standard rubber dam in pediatric restorative dentistry |