Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-27 @ 6:32 AM
Study NCT ID:
NCT05554757
Status:
UNKNOWN
Last Update Posted:
2022-09-26
First Post:
2022-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
In Vivo Comparative Study of Two Different Rubber Dam System in Dental Practices
Sponsor:
Pakistan Institute of Medical Sciences
Organization:
Study Overview
Official Title:
In Vivo Comparative Study of Two Different Rubber Dam System in Dental Practices
Status:
UNKNOWN
Status Verified Date:
2022-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: