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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03713918
Recruitment Status : Not yet recruiting
First Posted : October 22, 2018
Last Update Posted : October 30, 2018
Information provided by (Responsible Party):
Sireen Taher Meheshi, Cairo University

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Endodontically Treated Teeth Other: Reinforced lithium silicate endocrowns Other: Post retained reinforced lith silicate crn Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients requiring posterior single crowns or endocrowns
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Participants and outcome assessor will be blinded to avoid performance, detection and analysis bias. Only main investigator will be aware of the allocated patients in each group and the specific type of intervention given to every patient
Primary Purpose: Treatment
Official Title: Clinical Assessment of Retention, Patient Satisfaction and Recurrent Caries of Endocrowns Versus Post Retained Crowns Using Reinforced Lithium Silicate.
Estimated Study Start Date : November 15, 2018
Estimated Primary Completion Date : October 30, 2019
Estimated Study Completion Date : November 30, 2019

Resource links provided by the National Library of Medicine

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 Name: 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.

Primary Outcome Measures :
  1. Recurrent caries [ Time Frame: one year ]
    It will be assessed using United States public health service (USPHS) criteria.

Secondary Outcome Measures :
  1. Patient satisfaction [ Time Frame: one year ]
    Questionnaire regarding patient satisfaction will be evaluated by the assessor

  2. 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)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.
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Responsible Party: Sireen Taher Meheshi, Assistant lecturer,fixed prosthodontic department,faculty of dentistry, Cairo University Identifier: NCT03713918    
Other Study ID Numbers: CEBD-CU-2018-10-18
First Posted: October 22, 2018    Key Record Dates
Last Update Posted: October 30, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tooth, Nonvital
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases
Lithium Carbonate
Antidepressive Agents
Psychotropic Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs