Endodontically Treated TeethNCT03713918
Clini Asses of Retentn,Pt Satisfactn and Recurrent Caries of Endocrs Versus Post Crs Using Reinforced Lithium Silicate
A study testing Reinforced lithium silicate endocrowns and Post retained reinforced lith silicate crn in people with Endodontically Treated Teeth, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Endodontically Treated Teeth
- What is being tested?
- Reinforced lithium silicate endocrowns and Post retained reinforced lith silicate crn
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2018to 30 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • 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
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Endodontically Treated Teeth
- Being tested
- Reinforced lithium silicate endocrowns, Post retained reinforced lith silicate crn
- Medical subject headings
- Tooth, Nonvital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reinforced lithium silicate endocrownsOther
Also called 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
Post retained reinforced lith silicate crnOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Reinforced lithium silicate endocrown | Experimental | Device: Endocrown restoration Receives: Other: Reinforced lithium silicate endocrowns |
| Reinforced lithi silicate crn e post | Active comparator | Device: Post retained reinforced lithium silicate crowns Receives: Other: Post retained reinforced lith silicate crn |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent caries
It will be assessed using United States public health service (USPHS) criteria.
Measured: one year
Secondary outcomes (2)
Patient satisfaction
Questionnaire regarding patient satisfaction will be evaluated by the assessor
Measured: one year
Retention
retention of the two groups will be assessed using the modified United States public health service (USPHS) criteria (Alpha,Bravo,Charlie)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2018
- Study start15 Nov 2018 (estimated)
- Primary completion30 Oct 2019 (estimated)
- Study completion30 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endodontically Treated TeethStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients requiring posterior single crowns or endocrowns
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sireen Taher Meheshi, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03713918
- Sponsor's protocol ID
- CEBD-CU-2018-10-18
- Status last verified
- Oct 2018
- First submitted
- 16 Oct 2018
- Last updated
- 30 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of Retention, Patient Satisfaction and Recurrent Caries of Endocrowns Versus Post Retained Crowns Using Reinforced Lithium Silicate.
- ClinicalTrials.gov ID
- NCT03713918
- Acronym / sponsor ID
- CEBD-CU-2018-10-18
- Conditions
- Endodontically Treated Teeth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Nov 2018 (estimated)
- Primary completion
- 30 Oct 2019 (estimated)
- Study completion
- 30 Nov 2019 (estimated)
- First posted
- 22 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients requiring posterior single crowns or endocrowns
| Arm | Type | Receives |
|---|---|---|
| Reinforced lithium silicate endocrown | Experimental | Other: Reinforced lithium silicate endocrownsDevice: Endocrown restoration |
| Reinforced lithi silicate crn e post | Active comparator | Other: Post retained reinforced lith silicate crnDevice: Post retained reinforced lithium silicate crowns |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- • Patient age range of 18-55 years.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reinforced lithium silicate endocrownsAlso: endocrownsThe endodontically treated tooth will be impressed, and an endocrown restoration will be manufactured with reinforced lithium silicate and cemented with self adhesive cement | Other | Reinforced lithium silicate endocrown |
| Post retained reinforced lith silicate crnThe 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. | Other | Reinforced lithi silicate crn e post |
Primary outcome
Recurrent caries
Time frame: one year
It will be assessed using United States public health service (USPHS) criteria.
2 secondary outcomes
Patient satisfaction
Time frame: one year
Retention
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Reinforced lithium silicate endocrowns and Post retained reinforced lith silicate crn in people with Endodontically Treated Teeth, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent caries (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2018.