Clini Asses of Retentn,Pt Satisfactn and Recurrent Caries of Endocrs Versus Post Crs Using Reinforced Lithium Silicate
Primary Purpose
Endodontically Treated Teeth
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Reinforced lithium silicate endocrowns
Post retained reinforced lith silicate crn
Sponsored by
About this trial
This is an interventional treatment trial for Endodontically Treated Teeth
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Reinforced lithium silicate endocrown
Reinforced lithi silicate crn e post
Arm Description
Device: Endocrown restoration
Device: Post retained reinforced lithium silicate crowns
Outcomes
Primary Outcome Measures
Recurrent caries
It will be assessed using United States public health service (USPHS) criteria.
Secondary Outcome Measures
Patient satisfaction
Questionnaire regarding patient satisfaction will be evaluated by the assessor
Retention
retention of the two groups will be assessed using the modified United States public health service (USPHS) criteria (Alpha,Bravo,Charlie)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03713918
Brief Title
Clini Asses of Retentn,Pt Satisfactn and Recurrent Caries of Endocrs Versus Post Crs Using Reinforced Lithium Silicate
Official Title
Clinical Assessment of Retention, Patient Satisfaction and Recurrent Caries of Endocrowns Versus Post Retained Crowns Using Reinforced Lithium Silicate.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 15, 2018 (Anticipated)
Primary Completion Date
October 30, 2019 (Anticipated)
Study Completion Date
November 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endodontically Treated Teeth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients requiring posterior single crowns or endocrowns
Masking
ParticipantOutcomes 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
Allocation
Randomized
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Reinforced lithium silicate endocrown
Arm Type
Experimental
Arm Description
Device: Endocrown restoration
Arm Title
Reinforced lithi silicate crn e post
Arm Type
Active Comparator
Arm Description
Device: Post retained reinforced lithium silicate crowns
Intervention Type
Other
Intervention Name(s)
Reinforced lithium silicate endocrowns
Other Intervention Name(s)
endocrowns
Intervention Description
The endodontically treated tooth will be impressed, and an endocrown restoration will be manufactured with reinforced lithium silicate and cemented with self adhesive cement
Intervention Type
Other
Intervention Name(s)
Post retained reinforced lith silicate crn
Intervention Description
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 Measure Information:
Title
Recurrent caries
Description
It will be assessed using United States public health service (USPHS) criteria.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Patient satisfaction
Description
Questionnaire regarding patient satisfaction will be evaluated by the assessor
Time Frame
one year
Title
Retention
Description
retention of the two groups will be assessed using the modified United States public health service (USPHS) criteria (Alpha,Bravo,Charlie)
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clini Asses of Retentn,Pt Satisfactn and Recurrent Caries of Endocrs Versus Post Crs Using Reinforced Lithium Silicate
We'll reach out to this number within 24 hrs