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In Vivo Comparative Study of Two Different Rubber Dam System in Dental Practices

Primary Purpose

Tooth Decay

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
conventional rubber dam system
OPTRADAM
Sponsored by
Pakistan Institute of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Tooth Decay

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Patients who agree to participate in study. Patients who came for restorative and endodontic purpose . Fully erupted molars and premolars. Patient having no previous experience with rubber dam system.

Exclusion Criteria:

Grossly carious tooth with poor prognosis. Medically compromised patients. Those Patient which are uncooperative. Patients having latex allergy

Sites / Locations

  • Aqsa waheedRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

conventional rubber dam system

OPTRADAM

Arm Description

in the first 30 patients, the conventional rubber dam was used prior to the OptraDam For the first 30 patients, on the day of the first appointment, the stopwatch was set for recording the time taken for the application of the conventional rubber dam . Following this, the required dental treatment was carried out. Radiographs were taken as & when necessary . At the end of the appointment, the questionnaires were filled by the patient as well as the operator regarding their experience of the conventional rubber dam

In second appoinment the optradam was applied. The stopwatch was set for the recording the time of application of the OptraDam. The required dental treatment was carried out. Radiographs were taken. At the end of the appointment, the questionnaires were again filled by the patient as well as the operator regarding their experience of the OptraDam.

Outcomes

Primary Outcome Measures

Moisture control
clinically observing tooth moisture control with optradam and coventional rubber dam system

Secondary Outcome Measures

Retraction and access
clinically observing hindrance with clasp during procedure
radiographic ease
radiograph easily taken with rubber dam system

Full Information

First Posted
July 22, 2022
Last Updated
September 21, 2022
Sponsor
Pakistan Institute of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05554757
Brief Title
In Vivo Comparative Study of Two Different Rubber Dam System in Dental Practices
Official Title
In Vivo Comparative Study of Two Different Rubber Dam System in Dental Practices
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
November 25, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pakistan Institute of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Isolation is essential for the successful placement of esthetic restoration to avoid any contamination of cavity with saliva ,secreation,and blood dental . This study is comparison of optradam and convetional rubberdam system.The aim of this study is to investigate which rubberdam system is better accepted by patients and dentists
Detailed Description
This is in vivo comparative study of optradam and conventional rubber dam system.For this study , two simple questionnaires were prepared. The first questionnaire consisted of 5 questions. It enquired into the personal details of the patient, which included the name, age & gender ,the patient's previous experience of rubber dam use The teeth to be isolated .The type of procedure being carried out The patient's comfort regarding the conventional rubber dam & the OptraDam .The patient's protection regarding the conventional rubber dam & the OptraDam. The patient's preference regarding the conventional rubber dam & the OptraDam The second questionnaire consisted of 7 questions. This was to be filled by the dentist operating on the respective patient. This questionnaire enquired into 1 The time taken to apply the conventional rubber dam & the OptraDam. 2 The ease with which rubber dam could be applied.The amount of retraction & access achieved during the use of each rubber dam. 3 The amount of moisture control achieved during the use of each rubber dam. 4 he ease with which radiograph could be taken. 5 The dentist's preference regarding the conventional rubber dam & OptraDam. In the first 30 patients, the conventional rubber dam was used prior to the OptraDam. In the next 30 patients, the OptraDam was used before the conventional rubber dam. This was done to prevent bias. For the first 30 patients, on the day of the first appointment, the stopwatch was set for recording the time taken for the application of the conventional rubber dam . Following this, the required dental treatment was carried out. Radiographs were taken as & when necessary . At the end of the appointment, the questionnaires were filled by the patient as well as the operator regarding their experience of the conventional rubber dam.On the next consecutive appointment, the stopwatch was set for the recording the time of application of the OptraDam. The required dental treatment was carried out. Radiographs were taken. At the end of the appointment, the questionnaires were again filled by the patient as well as the operator regarding their experience of the OptraDam. For the next set of 30 patients, the above procedure was repeated, except that, for them the OptraDam was used prior to conventional rubber dam]. DATA ANALYSIS: All statistical analyses are performed with SPSS 13.0 . Analyses were confined to simple cross tabulations of the patients & operator . P - value was calculated using Chi-square test & Wilcoxon test whenever required to get appropriate results

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Decay

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
conventional rubber dam system
Arm Type
Experimental
Arm Description
in the first 30 patients, the conventional rubber dam was used prior to the OptraDam For the first 30 patients, on the day of the first appointment, the stopwatch was set for recording the time taken for the application of the conventional rubber dam . Following this, the required dental treatment was carried out. Radiographs were taken as & when necessary . At the end of the appointment, the questionnaires were filled by the patient as well as the operator regarding their experience of the conventional rubber dam
Arm Title
OPTRADAM
Arm Type
Active Comparator
Arm Description
In second appoinment the optradam was applied. The stopwatch was set for the recording the time of application of the OptraDam. The required dental treatment was carried out. Radiographs were taken. At the end of the appointment, the questionnaires were again filled by the patient as well as the operator regarding their experience of the OptraDam.
Intervention Type
Device
Intervention Name(s)
conventional rubber dam system
Intervention Description
rubber dam is a protective sheet with a hole that a dental professional positions over a tooth during an endodontic procedureEndodontists . This allows to isolate the treatment area with a dental clamp around the tooth. The dental sheet is placed around the in the Dental Rubber Dams and then a u-shaped device is hooked around. This isolates the single tooth where dental treatment will be conducted.
Intervention Type
Device
Intervention Name(s)
OPTRADAM
Intervention Description
OptraDam Plus is a three-dimensional rubber dam that is flexible and has an anatomical shape, automatically stretched in an oral direction, an automatic hold of the device in the oral cavity is ensured.
Primary Outcome Measure Information:
Title
Moisture control
Description
clinically observing tooth moisture control with optradam and coventional rubber dam system
Time Frame
immediately after procedure
Secondary Outcome Measure Information:
Title
Retraction and access
Description
clinically observing hindrance with clasp during procedure
Time Frame
immediately after procedure
Title
radiographic ease
Description
radiograph easily taken with rubber dam system
Time Frame
immediately after procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients who agree to participate in study. Patients who came for restorative and endodontic purpose . Fully erupted molars and premolars. Patient having no previous experience with rubber dam system. Exclusion Criteria: Grossly carious tooth with poor prognosis. Medically compromised patients. Those Patient which are uncooperative. Patients having latex allergy
Facility Information:
Facility Name
Aqsa waheed
City
Islamabad
State/Province
Islambad
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
AQSA WAHEED, BDS
Phone
03063422518
Email
q.aqsa@rocketmail.com
First Name & Middle Initial & Last Name & Degree
Nosheen SARWAR, BDS
Phone
03088895652
First Name & Middle Initial & Last Name & Degree
Aqsa WAHEED, BDS

12. IPD Sharing Statement

Plan to Share IPD
No

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In Vivo Comparative Study of Two Different Rubber Dam System in Dental Practices

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