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

Pakistan Institute of Medical Sciences

Status: Enrolling

Conditions: Tooth Decay

Treatments: Device: OPTRADAM; Device: conventional rubber dam system

Study type: Interventional

Funder types: Other

Identifiers

NCT05554757

AQ27101996

Details and patient eligibility

About

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

Full 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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

conventional rubber dam system

Experimental group

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

Treatment:

Device: conventional rubber dam system

OPTRADAM

Active Comparator group

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.

Treatment:

Device: OPTRADAM