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

NCT ID: NCT05554757

Last Updated: 2022-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2022-12-01

Brief Summary

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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

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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

Conditions

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Tooth Decay

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

conventional rubber dam system

Intervention Type DEVICE

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.

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.

Group Type ACTIVE_COMPARATOR

OPTRADAM

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pakistan Institute of Medical Sciences

OTHER_GOV

Sponsor Role lead

Responsible Party

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Aqsa Waheed

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Aqsa waheed

Islamabad, Islambad, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Facility Contacts

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AQSA WAHEED, BDS

Role: primary

03063422518

Nosheen SARWAR, BDS

Role: backup

03088895652

Other Identifiers

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AQ27101996

Identifier Type: -

Identifier Source: org_study_id

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