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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05554757
Other study ID # AQ27101996
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2022
Est. completion date December 1, 2022

Study information

Verified date September 2022
Source Pakistan Institute of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 1, 2022
Est. primary completion date November 25, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Pakistan Aqsa waheed Islamabad Islambad

Sponsors (1)

Lead Sponsor Collaborator
Pakistan Institute of Medical Sciences

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Moisture control clinically observing tooth moisture control with optradam and coventional rubber dam system immediately after procedure
Secondary Retraction and access clinically observing hindrance with clasp during procedure immediately after procedure
Secondary radiographic ease radiograph easily taken with rubber dam system immediately after procedure
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