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

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

Study Overview

• Status: Recruiting
• Conditions: Tooth Decay
• Intervention / Treatment: Device: conventional rubber dam system; Device: OPTRADAM

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

1. The teeth to be isolated
2. .The type of procedure being carried out
3. The patient's comfort regarding the conventional rubber dam & the OptraDam
4. .The patient's protection regarding the conventional rubber dam & the OptraDam.
5. 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

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Islambad
    • Islamabad, Islambad, Pakistan
      • Recruiting
      • Aqsa waheed
      • Contact: Nosheen SARWAR, BDS; Phone Number: 03088895652
      • Principal Investigator: Aqsa WAHEED, BDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: conventional rubber dam system; 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	Device: conventional rubber dam system; 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.
Active Comparator: OPTRADAM; 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.	Device: OPTRADAM; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Moisture control	clinically observing tooth moisture control with optradam and coventional rubber dam system	immediately after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retraction and access	clinically observing hindrance with clasp during procedure	immediately after procedure
radiographic ease	radiograph easily taken with rubber dam system	immediately after procedure

Collaborators and Investigators

• Sponsor: Pakistan Institute of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Anticipated): November 25, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: July 22, 2022
• First Submitted That Met QC Criteria: September 21, 2022
• First Posted (Actual): September 26, 2022

Study Record Updates

• Last Update Posted (Actual): September 26, 2022
• Last Update Submitted That Met QC Criteria: September 21, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: AQ27101996

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No