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CTRI Number  CTRI/2025/04/084061 [Registered on: 03/04/2025] Trial Registered Prospectively
Last Modified On: 23/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   comparative evaluation anxity and chairside time of three different isoloation techniques in children. 
Scientific Title of Study   Comparative evaluation of anxiety and chairside time with three different isolation systems in children 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  Simran Deorukhkar 
Designation  Post Graduate Student 
Affiliation  Dr DY Patil Vidyapeeth Pune 
Address  No. 8 Department of Pediatric and Preventive Dentistry Dr DY Patil Dental College And Hospital Sant Tukaram Nagar Pimpri Pune
No. 8 Department of Pediatric And Preventive Dentistry Dr DY Patil Dental College And Hospital Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA
411018
India 
Phone  912067116419  
Fax    
Email  srd.vlp56@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Lalit Patil 
Designation  Associate Professor 
Affiliation  Dr DY Patil Vidyapeeth Pune 
Address  No.8 Department of Pediatric and Preventive Dentistry Dr DY Patil Dental College And Hospital Sant Tukaram Nagar Pimpri Pune

Pune
MAHARASHTRA
411018
India 
Phone  9765370827  
Fax    
Email  lalit.patil@dpu.edu.in  
 
Details of Contact Person
Public Query
 
Name  Simran Deorukhkar 
Designation  Post Graduate Student 
Affiliation  Dr DY Patil Vidyapeeth Pune 
Address  Department of Pediatric And Preventive Dentistry Dr DY Patil Dental College And Hospital Sant Tukaram Nagar Pimpri pune

Pune
MAHARASHTRA
411018
India 
Phone  9757362682  
Fax    
Email  srd.vlp56@gmail.com  
 
Source of Monetary or Material Support  
Department of Pediatric And Preventive Dentistry Dr DY Patil Dental college And Hospital Sant Tukaram Nagar Pimpri Pune 411018 India 
 
Primary Sponsor  
Name  Simran Deorukhkar 
Address  Dr DY Patil Dental College And Hospital Sant Tukaram Nagar Pimpri Pune 
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 Simran Deorukhkar  Dr DY Patil Dental College And Hospital  Dr DY Patil Dental College And Hospital Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA 
9757362682

srd.vlp56@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee Dr DY Patil Vidyapeeth Pune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K025||Dental caries on pit and fissure surface,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Rubber Dam  1.To evaluate and compare anxiety of children aged 6-9 years treated under rubber dam. 2.To evaluate and compare time consumption right from preparation, placement and removal of rubber dam in children aged 6-9 years.  
Intervention  Minidam  1.To evaluate and compare anxiety of children aged 6 to 9 years treated under MiniDam. 2.To evaluate and compare time consumption right from preparation, placement and removal of Minidam in children aged 6 to 9 years.  
Intervention  Optradam plus  1.To evaluate and compare anxiety of children treated under OptraDam Plus. 2.To evaluate and compare time consumption right from preparation, placement and removal of OptraDam Plus in children.  
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  Healthy children male or female of age 6 to 9 years with Frankl’s behaviour rating score 3 and 4 with presence of Class I caries in mandibular arch who require single tooth restoration with type IX Glass Ionomer Cement following standard protocol of restoration. 
 
ExclusionCriteria 
Details  1. Child with upper respiratory tract infection, congestion of nasal passage or other nasal obstruction.

2.Patients with allergy to latex.

3. Children with special health care needs.

4. Children falling under Frankel behaviour rating score 1 and 2.

5. Children with mouth breathing habit.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To evaluate and compare anxiety of children aged 6 to 9 years treated under rubber dam, OptraDam Plus and MiniDam.

2. To evaluate and compare time consumption right from preparation, placement and removal of rubber dam, OptraDam Plus and Minidam in children aged 6 to 9 years.
 
6 months 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   N/A 
Date of First Enrollment (India)   03/04/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  03/04/2025 
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  

Need for the study :

The success rate of any dental treatment in pediatric patients depends upon certain factors which include, the successful Behaviour management of the child, relieving the fear and anxiety associated with the treatment and the quality of the treatment provided. Proper isolation is one of the most crucial factors in determining the success or the failure of the treatment of the child, however, maintaining a dry operating field becomes a little difficult in case of pediatric patients due to various factors.

Rubber Dam was invented by Barnum in 1864.1 It has been used since ages as an effective means for isolation in dentistry. It plays a vital role in maintaining the operating site free of saliva and tissue fluids. 

The main advantage of conventional rubber dam is that it maintains a clean and dry working environment which improves the quality of the clinical procedure. However, there are a few drawbacks of conventional rubber dam, such as the placement of the dam can induce anxiety in a child as the rubber dam system consists of various components which can be overwhelming for the child. It can be time consuming as the rubber dam placement is a stepwise procedure. It is suggestive that because of these reasons there is a resistance among clinicians for the use of Rubber dam on a regular basis in children . 

Various advances have been made in the rubber dam with OptraDamPlus being one of them. The anatomical shape, high flexibility and patented inner-ring design allows it to be placed without the need for clamps.2 

Another new advancement in rubber dam system is MiniDam. MiniDam (DMG America LLC) was introduced recently to aid in isolation in restoration of proximal lesions. It is a two-tooth slot system, latex free and is stabilized without the use of clamps. 3 

Hence a present study is undertaken to carry out comparison between conventional , OptraDam Plus and MiniDam in pediatric patients to check anxiety level of child and at the same time chairside time consumption of the operator.

Review of Literature :

   Priyanka Sehgal (2019) et al conducted a study on use of MiniDam for isolation in restoration of proximal carious lesion. This was a randomized controlled study. The efficacy of isolation along with child’s behavior and pain perception and time taken for applicaton was checked. This study concluded that Minidam was as effective as Rubber dam and required significantly less time for placement.3

 Martin Kapitan (2015) et al. conducted a study comparison of three rubber dam systems in-vivo. It was a preliminary study. The study included questionnaire which was filled by the patients. The time of preparation, placement, presence and removal of the dams  were measured and the quality of isolation was evaluated. This study concluded that placement of Opti Dam was similar to conventional dam and placement of Optradam was longer.4

  Prachi Joshi (2016) et al. conducted a study showing comparison in conventional and new rubber dam system in dental practice. It was a questionnaire based study. There were 2 questionnaire system, the first questionnaire included 5 questions filled by patients and second included 7 questions filled by dentist. They concluded that both patients and the dentist preferred conventional rubber dam over the Optradam.5

 SA Feierabend (2011) et al conducted a study to compare conventional and new rubber dam system in dental practice. It was a questionnaire based study. There were 3 questionnaires out of which one was filled by patient and remaining two were filled by dentist. The study concluded that there is a high degree of acceptance of rubber dam when its use is compulsory and this acceptance is independent of the material or design available.6

Martin Kapiten (2014) et al conducted a study to compare different rubber dam systems on a dental simulator. The rubber dam systems were applied on dental simulator and time of preparation, application and removal along with the quality of isolation was evaluated. They concluded that OptiDam showed better isolation quality that conventional rubber dam and Optra Dam showed inferior quality than conventional rubber dam.7

Aim of Study : 

To evaluate and compare the anxiety and chairside time with Conventional Rubber Dam, OptraDam Plus and MiniDam in children.

  Objectives of this study:

To evaluate and compare anxiety of children aged 6 to 9 years treated under rubber dam, OptraDam Plus and MiniDam.

To evaluate and compare time consumption right from preparation, placement and removal of rubber dam, OptraDam Plus and Minidam in children aged 6 to 9 years.

 Materials and methods:

Source of data

● Type of study – Randomized Clinical Trial

                        

● In-vitro/in-vivo/survey – In – vivo study

 

● Source from where the cases, patients, subjects, or study material will be

   selected-

    Dept Of Pediatric And Preventive Dentistry

  Dr. D. Y Patil Dental College And Hospital, Pimpri, Pune.

● Name and place where the study will be conducted-

      Dept Of Pediatric And Preventive Dentistry

  Dr. D. Y Patil Dental College And Hospital, Pimpri, Pune.

 Method of data collection

● Sampling technique used – Simple Random Sampling

● Sample size – 60 children

·         Size of each group : 20

Group I : Conventional Rubber dam

Group II: OptraDam Plus

Group III : MiniDam

 â— Inclusion criteria:

  1.   Healthy children male or female of age 6 to 9 years with Frankl’s behaviour rating score 3 and 4 with presence of Class I caries in mandibular arch who require single tooth restoration with type IX Glass Ionomer Cement following standard protocol of restoration.

 â— Exclusion criteria:

1.       Child with upper respiratory tract infection, congestion of nasal passage or other nasal obstruction.

2.      Patients with allergy to latex.

3.      Children with special health care needs.

4.      Children falling under Frankel behaviour rating score 1 and 2.

5.      Children with mouth breathing habit.

 Â·         Prior to starting the research work, permission to conduct the study will be obtained from the Scientific and Ethical committee of the Dr. D.Y Patil Dental College and Hospital.

·         A written Informed consent will be duly obtained from the parents prior to the conduction of the study.

●               Enlist the materials / instruments/armamentarium to be used in the study

 MATERIALS

1.      Type IX Glass Ionomer Cement

2.       Modified Dental Anxiety Scale ( MDAS)

3.       Conventional Rubber dam

4.       OptraDam Plus

5.       Minidam

 

INSTRUMENTS :

1.      Diagnostic instruments : mouth mirror, tweezer, probe, explorer.

2.      Spoon excavator

3.      GIC Mixing Pad

4.      Agate spatula

ARMAMENTERIUM :

1.      Mouth mask, Head cap

2.      Gloves

●Step-wise chronological sequence.

Patients will be selected according to the inclusion and exclusion criteria. The study procedure will be explained to each participant’s parents and necessary informed consent will be obtained in a language that they understand. Patients will be divided into three groups randomly by computer generated random numbers.Group 1 : conventional Rubber dam, Group 2: optradam plus, Group 3: minidam. Anxiety will be assessed using the Modified Dental Anxiety Scale pre - operatively. The vitals of the child will be recorded for further assessment of  pre-treatment anxiety. Rubber dam system will be placed , observer will use the stopwatch to record the time of preparation, placement and removal of the dam. Post treatment anxiety will  be assessed using the Modified Dental Anxiety Scale. The vitals of the child will be recorded for further assessment of the post- treatment anxiety. Data will be recorded and tabulated and results will be analyzed using statistical analysis method.

Duration of study. :1.5 years

Method of data analysis. :  One way ANOVA and Post Hoc Test

Does the study require any investigation or intervention to be made on patients,     any human or animals – Yes 

LIST OF REFERENCES:

1.      1.Tandon S. Textbook of Pedodontics. Paras Medical Publisher, 2009.

2.    2.  Zahra SF, Yousaf A, Ashfaq S, Ali F, Aslam M, Nayyar S. Different Techniques for Rubber Dam Isolation: A Cross Sectional Study. Life and Science. 2021; 2(3): 88-92. doi: http://doi.org/10.37185/LnS.1.1.124.

1.   3.   Priyanka R Sehgal and Uma B Dixit. “Use of Minidam for Isolation in Restoration of Proximal Carious Lesion”. Acta Scientific Dental Sciences 3.5 (2019): 105-109

2.     4. Kapitan, Martin & Kleplová, Tereza & Suchánek, Jakub. A Comparison of Three Rubber Dam Systems in Vivo: A Preliminary Study. Acta Medica (Hradec Kralove, Czech Republic). 58.( 2015) 15-20. 10.14712/18059694.2015.86.

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