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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.
 
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