| CTRI Number |
CTRI/2025/12/098254 [Registered on: 01/12/2025] Trial Registered Prospectively |
| Last Modified On: |
10/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study on Comfort of Children and Ease for Dentists Using Three Isolation Methods |
|
Scientific Title of Study
|
Comparative Evaluation Of
Ease Of Operator and Patient
Acceptability While Using
Three Different Isolation
Systems In Children-A 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 Anushka Manish Choche |
| Designation |
Post Graduate Student |
| Affiliation |
Sri Siddhartha Dental College and Hospital,Tumkur |
| Address |
Room no 6,Department of pedodontics and preventive dentistry, Sri Siddhartha Dental college and Hospital Tumkur, Karnataka, India
Tumkur KARNATAKA 572107 India |
| Phone |
9405325325 |
| Fax |
|
| Email |
anushkachoche@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Jyothsna V Setty |
| Designation |
Professor and HOD |
| Affiliation |
Sri Siddhartha Dental college and Hospital. |
| Address |
Room no 6,Department of pedodontics and preventive dentistry, Sri Siddhartha Dental college and Hospital Tumkur, Karnataka,India
Tumkur KARNATAKA 572107 India |
| Phone |
09449819468 |
| Fax |
|
| Email |
jyothsnasrikanth@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Jyothsna V Setty |
| Designation |
Professor and HOD |
| Affiliation |
Sri Siddhartha Dental college and Hospital. |
| Address |
Room no 6,Department of pedodontics and preventive dentistry, Sri Siddhartha Dental college and Hospital Tumkur, Karnataka,India
Tumkur KARNATAKA 572107 India |
| Phone |
09449819468 |
| Fax |
|
| Email |
jyothsnasrikanth@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room NO.6, Department of Pedodontics and Preventive Dentistry, Sri Siddhartha Dental College and Hospital Tumkur-572107 |
|
|
Primary Sponsor
|
| Name |
Dr. Anushka Manish Choche |
| Address |
Room no 6,Department of pedodontics and preventive dentistry, Sri Siddhartha Dental college and Hospital Tumkur, Karnataka,India -572107 |
| 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 Jyothsna V Setty |
Sri Siddhartha Dental College and Hospital |
Room no 6, Department of pedodontics and preventive dentistry, Sri Siddhartha dental college and hospital tumkur-572107 Tumkur KARNATAKA |
09449819468
jyothsnasrikanth@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Siddhartha Dental College Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: K023||Arrested dental caries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
using drydent parotid and sublingual absorber for isolation in children |
To evaluate and assess the effectiveness of parotid and sublingual saliva absorber pads for isolation in children |
| Comparator Agent |
using rubber dam cotton roll for isolation in children |
evaluate and assess the effectiveness and patient comfort using rubber dam group and cotton roll group for isolation in children |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
1. Children age group between 4 and9 years
2. who had positive or definitely positive cooperation level according to the Frankl
Behavior Rating Scale
3. Children with no history of previous restoration in the selected teeth.
4. Children without any systemic or mental disorders.
5. Molars indicated for class II restorations
6. Children with no known allergy to the materials used in the study.
7. Teeth with no signs of irreversible pulpitis, periodontally compromised teeth.
8. Patients who willfully give assent and for whom the parents or guardian will give the
written informed consent to be part of this study |
|
| ExclusionCriteria |
| Details |
1. Teeth with deep carious lesions involving the pulp.
2. Presence of any systemic disorders.
3.Special healthcare need children.
4.Patients on medications affecting salivary flow
5.Patients with known allergy to latex of rubber dam.
6.Patients who are not willing or for whom the parent or the guardian did not give the
written informed consent for the treatment |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare the effectiveness of different isolation methods—cotton rolls, rubber dam,
drydent sublingual and parotid Absorbers for the class II restoration of primary molars among
patient aged between 4to9 years |
comparing the effectiveness of different isolation methods during the restoration procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| patient comfort during the restoration |
patient comfort during the restorative procedure |
|
|
Target Sample Size
|
Total Sample Size="36" Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="36" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/12/2025 |
| Date of Study Completion (India) |
23/03/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
23/03/2026 |
|
Estimated Duration of Trial
|
Years="1" Months="3" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Effective moisture control is crucial in pediatric dentistry to ensure the success of various dental procedures including restorative treatments, sealant application, bonding. salivary contamination can compromise the bonding efficiency, reduce the longevity of restorations, and increase the risk of secondary caries.1
Treating children often requires specialized techniques that differ from adult dental care. patients may have trouble staying still, following instructions, or tolerating certain procedures due to fear, discomfort. Additionally, the smaller size of their mouths poses challenges for effective isolation. As a result, the isolation method chosen must balance effectiveness with patient comfort.2
Generally traditional isolation is achieved using cotton roll and a mouth mirror, Rubber dam, suction devices. Cotton Roll is a simple, non-invasive method often preferred for children who are uncooperative or anxious. However, cotton rolls may not always provide the best moisture control, especially in more complex procedures. Rubber Damis considered the gold standard for isolation in many dental procedures, rubber dams offer superior moisture control but can be uncomfortable or difficult to apply in younger patients. Suction devices require active patient cooperation and may not fully control saliva from parotid and sublingual glands.3
Methods like rubber dams provide excellent moisture control but children show lot of discomfort when placed. Techniques like cotton rolls offer a more tolerable option but may lack the moisture control necessary for some procedures.
Recently introduced, Drydent sublingual and parotid Absorber have emerged as alternative isolation techniques that can efficiently absorb saliva while providing comfortable experience for pediatric patients, easy to place and remove improving clinical efficiency. These are placed directly over the open ducts of the salivary glands, where saliva production is most abundant. By absorbing saliva at this source, it effectively maintains a drier working area throughout dental treatments. Its soft, tissue-friendly design ensures patient comfort during use. Sublingual Absorber is designed to collect and control saliva produced by the sublingual and submandibular glands, this product offers an effective solution for managing moisture in the oral cavity. Its unique design ensures optimal moisture control during dental procedures. However, there are no studies on the effectiveness of dry dent Absorber in patients and there is no comparative evaluation with currently used isolation methods. |