Postoperative Hypersensitivity and Digital Radiographic Assessment of a Zinc Modified Versus a Conventional Glass Ionomer Cement in Deep Carious Lesion: Randomized Controlled Clinical Trial

September 14, 2017 updated by: Dina mounir elkady, Cairo University
The study aim to evaluate the difference between the effect of zinc modified glass ionomer and conventional glass ionomer on the success of partial caries removel technique

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The zinc ion has an antibacterial effect which could increase the success of partial caries removel technique by decreasing the bactrial population .

Study Type

Interventional

Enrollment (Anticipated)

52

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 Contact Backup

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female (>18 y)
  2. patient with At least 1 deep carious lesion
  3. Clinical symptoms of reversible pulpitis with positive pulp response

Exclusion Criteria:

  • 1. Patient suffer from irreversible pulpitis (pain with hot or instant pain lasting for a while, resistant to analgesic) 2. Presence of any sign of periapical lesion (like sinus tract ) 3. Teeth with periodontal problem 4. Anterior teeth (material used for non aesthetic region) 5. Pregnant women, to avoid multiple exposure to x ray 6. Patients unable to give consent(mentally retarted, or refuse to right a consent)

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Zinc modified glass ionomer
Zinc modified glass ionomer (chemfill rock) galss ionomer used as restoration for posterior teeth in case of partial caries removel
Procedure: Partial caries removel techniques
Removel of all superfacial dentin and leaving the inner affectted dentin
Other Names:
  • Partial caries removel
Active Comparator: Conventionel glass ionomer
Conventional glass ionomer used as restoration for posterior teeth in case of partial caries removel
Procedure: Partial caries removel techniques
Removel of all superfacial dentin and leaving the inner affectted dentin
Other Names:
  • Partial caries removel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Digital radigraphic assessment
Time Frame: At baseline ,3months and 6 months
The presence of periapical change or change in lamina dura change after the procedure
At baseline ,3months and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post opreative hypersenstivity
Time Frame: Baseline ,at 3 months and at 6 months
The presence or absence of pain with thermal
Baseline ,at 3 months and at 6 months

Collaborators and Investigators

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

Sponsor

Cairo University

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)

October 20, 2017

Primary Completion (Anticipated)

April 20, 2018

Study Completion (Anticipated)

April 20, 2018

Study Registration Dates

First Submitted

September 14, 2017

First Submitted That Met QC Criteria

September 14, 2017

First Posted (Actual)

September 15, 2017

Study Record Updates

Last Update Posted (Actual)

September 15, 2017

Last Update Submitted That Met QC Criteria

September 14, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEBD-CU-2017-09-17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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Locations

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