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

NCT ID: NCT03562858

Last Updated: 2018-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-31

Study Completion Date

2018-10-31

Brief Summary

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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

Detailed Description

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Conditions

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Hypersensitivity Dentin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Delayed dentine sealing

Group Type ACTIVE_COMPARATOR

Delayed dentin sealing protocol

Intervention Type PROCEDURE

Sealing the dentin just prior to cementation

Immediate dentin sealing

Group Type EXPERIMENTAL

Immediate dentin sealing protocol

Intervention Type PROCEDURE

Sealing of the dentin before impression taking directly after cavity preparation to prevent postoperative hypersensitivity during provisionalization and after cementation

Interventions

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Immediate dentin sealing protocol

Sealing of the dentin before impression taking directly after cavity preparation to prevent postoperative hypersensitivity during provisionalization and after cementation

Intervention Type PROCEDURE

Delayed dentin sealing protocol

Sealing the dentin just prior to cementation

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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hoda omar tawfeek hussien fouda

Principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of dentistry cairo university

Cairo, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Hoda Fouda, Master

Role: CONTACT

01003786531

Facility Contacts

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Hoda Fouda

Role: primary

01003786531

Other Identifiers

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CEBD-CU-2018-05-21

Identifier Type: -

Identifier Source: org_study_id

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