Clini Asses of Retentn,Pt Satisfactn and Recurrent Caries of Endocrs Versus Post Crs Using Reinforced Lithium Silicate

October 26, 2018 updated by: Sireen Taher Meheshi, Cairo University

Clinical Assessment of Retention, Patient Satisfaction and Recurrent Caries of Endocrowns Versus Post Retained Crowns Using Reinforced Lithium Silicate.

Coronal retention of the restoration of RCT teeth is usually compromised, thus intraradicular posts combined or not with core material may be required.

The drawbacks of the conventional treatment created a necessary demand to have alternative treatment options. Among these options is the endocrown restoration. The pulpal chamber cavity provides retention and stability. Its trapezoidal shape in mandibular molars and triangular shape in maxillary molars increase the restoration's stability. The saddle form of the pulpal floor increases stability. This anatomy, along with the adhesive qualities of the bonding material, make no need for additional preparation or further use of post-involving root canals.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Aim of the study:

The aim of this study is to evaluate the effect of using reinforced lithium silicate endocrowns on the recurrent caries, patient satisfaction and retention in comparison to post retained reinforced lithium silicate crowns.

The study is held to evaluate recurrent caries,patient satisfaction and retention of endodontically treated teeth restored with Endocrowns versus Post Retained Crowns using Reinforced Lithium Silicate after one year follow up .

The clinical performance of ceramic endocrowns showed a survival rate of 99 % and the success rate of 89.9 % in a 10 year retrospective study done by Bellflamme et al. 2017.

Endocrowns; a recently developed line of treatment, take the advantage of the rapidly growing discipline of adhesion to glass ceramics. As the retention and recurrent caries are decisive factors in the prognosis of a restoration' they have to be thoroughly investigated.

Patients with endodontically treated lower first molars will be collected.after teeth preparation to receive endocrowns and crowns ,secondary impressions will be taken .The Patients will be divided randomly into two groups .One group will receive reinforced Lithium Silicate Endocrowns (intervention)and the other group will receive reinforced Lithium Silicate Crowns (control) retained with fiber posts.

Study Type

Interventional

Enrollment (Anticipated)

18

Phase

  • Not Applicable

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 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • • Patient age range of 18-55 years.

    • Patients physically and psychologically able to tolerate conventional restorative procedures.
    • Co-operative patients approving to participate in this trial.
    • Patients with root canal treated lower first molars requiring full coverage restoration.
    • Patients willing to return for follow-up examinations and assessments.
    • Endodontically treated teeth with absence of clinical diagnosis of periapical pathosis, fistula, swelling of periodontal tissues, abnormal tooth mobility and history of sensitivity to pressure

Exclusion Criteria:

  • Patients in the growth stage with partially erupted teeth.
  • Patients with poor oral hygiene.
  • Disabilities which will not be cooperative patient for the study.
  • Systemic diseases or severe medically compromised patients as uncontrolled diabetes or oral cancer.
  • Patients suffer from parafunctional habits
  • Teeth with fractured roots
  • Teeth with lesions extending apical to the cemento-enamel junction
  • Poor oral hygiene.

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Reinforced lithium silicate endocrown
Device: Endocrown restoration
Other: Reinforced lithium silicate endocrowns
The endodontically treated tooth will be impressed, and an endocrown restoration will be manufactured with reinforced lithium silicate and cemented with self adhesive cement
Other Names:
  • endocrowns
ACTIVE_COMPARATOR: Reinforced lithi silicate crn e post
Device: Post retained reinforced lithium silicate crowns
Other: Post retained reinforced lith silicate crn
The endodontically treated tooth will receive a fiber post cemented with self adhesive cement and after this, the tooth will be impressed and reinforced lithium silicate crown will be cemented with self adhesive cement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrent caries
Time Frame: one year
It will be assessed using United States public health service (USPHS) criteria.
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction
Time Frame: one year
Questionnaire regarding patient satisfaction will be evaluated by the assessor
one year
Retention
Time Frame: one year
retention of the two groups will be assessed using the modified United States public health service (USPHS) criteria (Alpha,Bravo,Charlie)
one year

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)

November 15, 2018

Primary Completion (ANTICIPATED)

October 30, 2019

Study Completion (ANTICIPATED)

November 30, 2019

Study Registration Dates

First Submitted

October 16, 2018

First Submitted That Met QC Criteria

October 18, 2018

First Posted (ACTUAL)

October 22, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 30, 2018

Last Update Submitted That Met QC Criteria

October 26, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEBD-CU-2018-10-18

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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