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

NCT05554757 | Unknown

• 1 other identifier: AQ27101996
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Tooth Decay

Outcome Measures

Primary Outcomes (1)

• Moisture control

  clinically observing tooth moisture control with optradam and coventional rubber dam system

  immediately after procedure

Secondary Outcomes (2)

• Retraction and access

  immediately after procedure

• radiographic ease

  immediately after procedure

Study Arms (2)

conventional rubber dam system

EXPERIMENTAL

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

OPTRADAM

ACTIVE COMPARATOR

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

Interventions

conventional rubber dam system 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.

conventional rubber dam system

OPTRADAM 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.

OPTRADAM

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Grossly carious tooth with poor prognosis. Medically compromised patients. Those Patient which are uncooperative. Patients having latex allergy

Sponsors & Collaborators

• Pakistan Institute of Medical Sciences: lead

Study Sites (1)

Aqsa waheed

Islamabad, Islambad, Pakistan

RECRUITING

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 22, 2022
• First Posted: September 26, 2022
• Study Start: June 1, 2022
• Primary Completion: November 25, 2022
• Study Completion: December 1, 2022
• Last Updated: September 26, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)