Post-operative Hyper-sensitivity Assessment After Immediate Versus Delayed Dentine Sealing in Teeth for Indirect Tooth Colored Restorations

June 8, 2018 updated by: hoda omar tawfeek hussien fouda, Cairo University

Post-operative Hyper-sensitivity Assessment After Immediate Versus Delayed Dentine Sealing in Teeth for Indirect Tooth Colored Restorations: Randomized Controlled Clinical Trial

PICOT elements:P: Teeth restored with indirect tooth colored restoration I: Immediate dentin sealing using universal adhesive C: Delayed dentin sealing O: Post-operative Hypersensitivity T: -Hypersensitivity assessment one week during provisionalization period and post-cementation S: Randomized Controlled Clinical Trial

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Cairo, Egypt, 002
        • Faculty of Dentistry Cairo University
        • Contact:
        • Principal Investigator:
          • Hoda Fouda, Master

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Extensive carious lesions indicated for indirect restorations
  • Lower first molars
  • Age of patients range is 18 -50 years
  • Patients have not received antibiotic therapy for 1 month before sampling
  • Males or Females (Both genders)
  • Patients with Good oral hygiene
  • Co-operative patients approving the trial

Exclusion Criteria:

  • Pregnancy
  • Systemic disease or severe medical
  • Patients having complications as:

Periodontal problems Mobile teeth, arrest caries and non-vital teeth

  • Heavy smoking patients
  • Xerostomia
  • Lack of compliance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Delayed dentine sealing
Sealing the dentin just prior to cementation
Experimental: Immediate dentin sealing
Sealing of the dentin before impression taking directly after cavity preparation to prevent postoperative hypersensitivity during provisionalization and after cementation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative hypersensitivity at baseline
Time Frame: 10 minutes
The post-operative hypersensitivity assessment will be performed at baseline , using visual analogue scale (VAS) for both intervention and control group . The visual analogue scale is a scale numbered from zero to 10 , where as the range from zero to three resembles from no to very mild sensitivity , the range from four to seven resembles moderate sensitivity and from eight to ten resembles severe sensitivity
10 minutes
Post-operative hypersensitivity one week after temporization
Time Frame: 1 week
The post-operative hypersensitivity will be assessed one week after temporization for both intervention and control group using the visual analogue scale VAS .The visual analogue scale is a scale numbered from zero to 10 , where as the range from zero to three resembles from no to very mild sensitivity , the range from four to seven resembles moderate sensitivity and from eight to ten resembles severe sensitivity
1 week
Post-operative hypersensitivity after cementation of the indirect tooth coloured restoration
Time Frame: 1 week
The post-operative hypersensitivity will be assessed using visual analogue scale VAS 1 week after cementation of the indirect tooth coloured restoration. The visual analogue scale is a scale numbered from zero to 10 , where as the range from zero to three resembles from no to very mild sensitivity, the range from four to seven resembles moderate sensitivity and from eight to ten resembles severe sensitivity
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2018

Primary Completion (Anticipated)

September 1, 2018

Study Completion (Anticipated)

October 1, 2018

Study Registration Dates

First Submitted

May 16, 2018

First Submitted That Met QC Criteria

June 8, 2018

First Posted (Actual)

June 20, 2018

Study Record Updates

Last Update Posted (Actual)

June 20, 2018

Last Update Submitted That Met QC Criteria

June 8, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEBD-CU-2018-05-21

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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