NCT03713918

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 22, 2018

Completed
24 days until next milestone

Study Start

First participant enrolled

November 15, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
Last Updated

October 30, 2018

Status Verified

October 1, 2018

Enrollment Period

12 months

First QC Date

October 16, 2018

Last Update Submit

October 26, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Recurrent caries

    It will be assessed using United States public health service (USPHS) criteria.

    one year

Secondary Outcomes (2)

  • Patient satisfaction

    one year

  • Retention

    one year

Study Arms (2)

Reinforced lithium silicate endocrown

EXPERIMENTAL

Device: Endocrown restoration

Other: Reinforced lithium silicate endocrowns

Reinforced lithi silicate crn e post

ACTIVE COMPARATOR

Device: Post retained reinforced lithium silicate crowns

Other: Post retained reinforced lith silicate crn

Interventions

The endodontically treated tooth will be impressed, and an endocrown restoration will be manufactured with reinforced lithium silicate and cemented with self adhesive cement

Also known as: endocrowns
Reinforced lithium silicate endocrown

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.

Reinforced lithi silicate crn e post

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Tooth, Nonvital

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients requiring posterior single crowns or endocrowns
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer,fixed prosthodontic department,faculty of dentistry

Study Record Dates

First Submitted

October 16, 2018

First Posted

October 22, 2018

Study Start

November 15, 2018

Primary Completion

October 30, 2019

Study Completion

November 30, 2019

Last Updated

October 30, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share