| CTRI Number |
CTRI/2025/02/080196 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
08/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative evaluation of breathing convenience and clinical acceptance of a novel mouth breathing device for rubber dam . |
|
Scientific Title of Study
|
Comparative evaluation of breathing convenience and clinical acceptance of a novel mouth breathing device for rubber dam:- A Randomized Clinical Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Geetanjali jain |
| Designation |
Student |
| Affiliation |
KM DENTAL COLLEGE and HOSPITAL |
| Address |
303 D Block Taksh Aura Ankhol road near L and T Knowledge city Vadodara Gujrat
Room Number 8 Department of Conservative and Endodontics KM Shah College and Dental Hospital Vadodara Gujrat.
Vadodara
GUJARAT
390019
India |
| Phone |
07987056146 |
| Fax |
|
| Email |
tarangeetanjali@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ajay singh rao |
| Designation |
professor |
| Affiliation |
KM DENTAL COLLEGE and HOSPITAL |
| Address |
room number 8 department of conservative and endodontics km shah college of dental sciences and resarch center vadodara gujrat
room number 8 department of conservative and endodontics km shah college of dental sciences and resarch center vadodara gujrat
Vadodara
GUJARAT
391760
India |
| Phone |
07987056146 |
| Fax |
|
| Email |
drajayinendo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Geetanjali jain |
| Designation |
Student |
| Affiliation |
KM DENTAL COLLEGE and HOSPITAL |
| Address |
303 D Block Taksh Aura near L & T Knowledge city Ankhol road Wagodiya Vadodara Gujrat
Room Number 8 Department of Conservative and Endodontics KM Shah college and Hospital Piparia Vadodara Gujrat
Vadodara
GUJARAT
390019
India |
| Phone |
07987056146 |
| Fax |
|
| Email |
tarangeetanjali@gmail.com |
|
|
Source of Monetary or Material Support
|
| KM Shah Dental College and Hospital Piparia Waghodia Vadodara Gujrat 391760 |
|
|
Primary Sponsor
|
| Name |
Dr Geetanjali jain |
| Address |
Room Number 8 Department of Conservative and Endodontics KM Shah Denatl College and Hospital Vadodara Gujrat |
| 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 |
| DR GEETANJALI JAIN |
KM Shah Dental College And Hospital piparia road waghodiya |
Room number 8 Department of Conservative and Endodontics KM Shah College of Dental College and Hospital, Pipariya
Vadodara
GUJARAT |
7415293089
tarangeetanjali@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| sumandeepvidyapeethinstitutionalethicscommittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
comparator |
to evaluate and compare the breathing convenience and clinical acceptance of using rubber dam during dental procedure |
| Intervention |
intervention |
To evaluate and compare the breathing convenience and clinical acceptance of a novel mouth breathing device for use with a rubber dam during dental procedures. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients between age group of 18-60 years ASA classification 1&2 with maxillary or mandibular single canal, single Rooted teeth diagnosed with Symptomatic Irreversible Pulpitis with normal periapical tissues will be included in the study.
Patients requiring dental procedures that necessitate the use of a rubber dam.
Patients with no history of respiratory disorders.
Patients who provide written informed consent
|
|
| ExclusionCriteria |
| Details |
Patients with severe or chronic apical periodontitis will be excluded.
Teeth with periapical abscess, granuloma, cyst will be excluded.
Medically compromised patients will be excluded.
Teeth with complex Root canal anatomy will be excluded.
Pregnant and lactating women will be excluded.
Patients with respiratory conditions such as asthma or COPD.
Patients with cognitive impairments affecting their understanding of the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the breathing convenience and clinical acceptance of a novel mouth breathing device for use with a rubber dam during dental procedures |
1 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparative Evaluation of Breathing Convenience and Clinical Acceptance of a New Patented Mouth Breathing Device for Rubber Dam: A Randomized Clinical Study.Comparative Evaluation and Clinical Acceptance of a New Patented Mouth Breathing Device for Rubber Dam. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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 4 |
|
Date of First Enrollment (India)
|
25/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/02/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study investigates the use of a novel mouth-breathing device designed to enhance breathing convenience and clinical acceptance during dental procedures requiring rubber dam isolation. Rubber dams are essential in dentistry for isolating teeth, improving visibility, and preventing microbial contamination. However, they can cause discomfort, especially for patients with restricted nasal breathing. The randomized clinical study evaluates whether this patented breathing device improves patient comfort and breathing ease compared to standard rubber dam techniques. Patients diagnosed with symptomatic irreversible pulpitis and undergoing endodontic treatment will be recruited. The study involves 36 participants, divided into two groups: one using the novel device with a rubber dam and the other using a standard rubber dam. The study’s objectives include assessing breathing comfort, clinical acceptance, and the device’s impact on upper airway patency and patient experience during dental treatments. A self-designed questionnaire will capture feedback from patients and clinicians. The research aims to provide evidence that the new device can reduce discomfort, enhance procedural efficiency, and improve the overall patient experience. This innovative approach could potentially standardize more comfortable practices in dentistry while maintaining high safety and infection control standards. The findings could lead to broader applications of the device across various dental fields, benefiting both patients and clinicians |