Endodontically Treated TeethNCT04511117
Endocrowns as Permanent Restorations for Endodontically Treated Permanent Molars in Young Age: Two-Year Follow up
A study testing Endocrown group in people with Endodontically Treated Teeth and Permanent Molars, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Background: A real challenge faces practitioners in dealing with permanent molars in young patients starting from proper selection of endodontic treatment system till the type of final coronal restoration. Read more about this study
- Who is it for?
- Ages 9 to 12 years
- Conditions the study is for
- Endodontically Treated Teeth, Permanent Molars
- What is being tested?
- Endocrown group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2019to 1 Nov 2021
- 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 9 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients were systemic free.
- Mature lower permanent first molar needs conventional endodontic treatment.
- The remaining coronal tooth structure after endodontic treatment is not less than 50%.
- Presence of teeth in opposite arch with normal occlusion.
- Absence of para-functional habits.
- Supra-gingival margin after preparation.
- No known allergies.
- Complaint patient (parent/ guardians)
Who cannot join
- Immature lower permanent first molar.
- Presence of teeth, whose coronal anatomy does not allow use of rubber dam for optimum bonding.
- Lack of cooperation of the patients to perform a postoperative radiograph and use a rubber dam for bonding.
Trial locations and contacts
1 site in 1 country.
About this study
Background: A real challenge faces practitioners in dealing with permanent molars in young patients starting from proper selection of endodontic treatment system till the type of final coronal restoration. For permanent molars in young age patients, which system should be followed to guarantee better performance and enhance the integrity of such weakened teeth? The question most commonly asked.
Purpose: To evaluate two-year clinical performance of endocrowns as permanent restorations for endodontically treated molars in young age.
Read the detailed description
Endodontic treatment will be done for all patients using ProTaper Next rotary files and iRoot SP sealer. Then patients were randomly divided into two groups;
Gr 1: Conventional group (CG), the coronal cavity will be restored directly with bulk-fill nanohybrid composite restorations.
Gr 2: Endocrown group (EG), the coronal cavity will be restored with IPS e.max CAD endocrown restorations.
- First step: Endodontic treatment protocol will be used as the following:
- Biomechanical preparation using; 2.6% NaOCl for irrigation, ProTaper Next rotary files for instrumentation and 17% EDTA gel for lubrication.
- Obturation of root canal using; ProTaper gutta-percha and iRoot SP sealer.
- Second step: Endocrown restoration protocol will be used as the following:
- Occlusal Butt joint design for Endocrown preparation.
- Putty-wash technique for taking impression.
- IPS e.max CAD for Endocrown construction.
- G-CEM self-adhesive resin cement for Endocrown cementation.
- Follow up visits: The patients will be recalled every 6 months for evaluation.
- Evaluation methods:
- Endodontic treatment evaluation: The outcome will be evaluated clinically and radiographically.
- Endocrown restoration evaluation: The outcome will be evaluated clinically in terms of; marginal adaptation, marginal discoloration and surface alteration.
- Conditions
- Endodontically Treated Teeth, Permanent Molars
- Being tested
- Control group, Endocrown group
- Keywords
- Endocrown,, Monoblock restoration,, Endodontically treated teeth, Young age
- Medical subject headings
- Tooth, Nonvital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control groupOther
ProTaper Next rotary system and iRoot SP sealer with composite restorations.
Endocrown groupOther
ProTaper Next rotary system and iRoot SP sealer with endocrown restorations.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | ProTaper Next rotary system and iRoot SP sealer will be used for root canal treatment, followed by composite restorations. Receives: Other: Control group |
| Endocrown Group | Experimental | ProTaper Next rotary system and iRoot SP sealer will be used for root canal treatment, followed by endocrown restorations. Receives: Other: Endocrown group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in marginal adaptation, discoloration and surface of the restoration.
Alpha:
No lack of continuity along the margin as observed with the explorer. No pigmentation anywhere on the margin.The surface of the restoration is unaltered.
Bravo:
Evidence of a crevice along the margin, but the explorer cannot penetrate.Pigmentation present but does not penetrate along the margin toward the pulp. The surface of the restoration shows wear, and must be controlled.
Charlie:
Evidence of a crevice along the margin, into which an explorer can penetrate. Requires control, repair or retreatment. Severe pigmentation. The restoration must be removed. The surface of the restoration shows perforations, fractures or significant tear. It must be polished, repaired or retreated.
Measured: At 6 months, 12 months, 18 months, and 24 months following application.
Secondary outcomes (1)
Change in the Retention Status.
Debonding or dislodgement of the restoration.
Measured: At 6 months, 12 months, 18 months, and 24 months following application.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start1 Oct 2019
- Primary completion1 Nov 2019
- Study completion1 Nov 2021
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 Al-Azhar 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Control group: the patient will receive direct composite resin restorations. Endocrown group: the patient will receive endocrown restorations.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roqaia Mohammad Alassar, Al-Azhar University
- Investigators
- Roqaia M Alassar, DDS, Principal investigator, Fixed Prosthodontist, Faculty of Dental Medicine for Girls, Al-Azhar UniversityHeba Abdelkafy, DDS, Principal investigator, Endodontist, Faculty of Dental Medicine for Girls, Al-Azhar UniversityEman Abdelraouf, DDS, Principal investigator, Pedodontist, Faculty of Dental Medicine for Girls, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04511117
- Sponsor's protocol ID
- PD-P-019-002
- Status last verified
- Dec 2021
- First submitted
- 8 Aug 2020
- Last updated
- 28 Dec 2021
- Results posted
- 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 28 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endocrowns as Permanent Restorations for Endodontically Treated Permanent Molars in Young Age: Two-Year Follow up
- ClinicalTrials.gov ID
- NCT04511117
- Acronym / sponsor ID
- PD-P-019-002
- Conditions
- Endodontically Treated Teeth, Permanent Molars
- Keywords
- Endocrown,, Monoblock restoration,, Endodontically treated teeth, Young age
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 13 Aug 2020 (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.
Background: A real challenge faces practitioners in dealing with permanent molars in young patients starting from proper selection of endodontic treatment system till the type of final coronal restoration. For permanent molars in young age patients, which system should be followed to guarantee better performance and enhance the integrity of such weakened teeth? The question most commonly asked.
Purpose: To evaluate two-year clinical performance of endocrowns as permanent restorations for endodontically treated molars in young age.
Detailed description
Endodontic treatment will be done for all patients using ProTaper Next rotary files and iRoot SP sealer. Then patients were randomly divided into two groups;
Gr 1: Conventional group (CG), the coronal cavity will be restored directly with bulk-fill nanohybrid composite restorations.
Gr 2: Endocrown group (EG), the coronal cavity will be restored with IPS e.max CAD endocrown restorations.
- First step: Endodontic treatment protocol will be used as the following:
- Biomechanical preparation using; 2.6% NaOCl for irrigation, ProTaper Next rotary files for instrumentation and 17% EDTA gel for lubrication.
- Obturation of root canal using; ProTaper gutta-percha and iRoot SP sealer.
- Second step: Endocrown restoration protocol will be used as the following:
- Occlusal Butt joint design for Endocrown preparation.
- Putty-wash technique for taking impression.
- IPS e.max CAD for Endocrown construction.
- G-CEM self-adhesive resin cement for Endocrown cementation.
- Follow up visits: The patients will be recalled every 6 months for evaluation.
- Evaluation methods:
- Endodontic treatment evaluation: The outcome will be evaluated clinically and radiographically.
- Endocrown restoration evaluation: The outcome will be evaluated clinically in terms of; marginal adaptation, marginal discoloration and surface alteration.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Control group: the patient will receive direct composite resin restorations. Endocrown group: the patient will receive endocrown restorations.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Control groupProTaper Next rotary system and iRoot SP sealer will be used for root canal treatment, followed by composite restorations. |
| Endocrown Group | Experimental | Other: Endocrown groupProTaper Next rotary system and iRoot SP sealer will be used for root canal treatment, followed by endocrown restorations. |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Patients were systemic free.
- Mature lower permanent first molar needs conventional endodontic treatment.
- The remaining coronal tooth structure after endodontic treatment is not less than 50%.
- Presence of teeth in opposite arch with normal occlusion.
- Absence of para-functional habits.
Key exclusion criteria (3 listed)
- Immature lower permanent first molar.
- Presence of teeth, whose coronal anatomy does not allow use of rubber dam for optimum bonding.
- Lack of cooperation of the patients to perform a postoperative radiograph and use a rubber dam for bonding.
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 |
|---|---|---|
| Control groupProTaper Next rotary system and iRoot SP sealer with composite restorations. | Other | Control Group |
| Endocrown groupProTaper Next rotary system and iRoot SP sealer with endocrown restorations. | Other | Endocrown Group |
Primary outcome
Change in marginal adaptation, discoloration and surface of the restoration.
Time frame: At 6 months, 12 months, 18 months, and 24 months following application.
Alpha: No lack of continuity along the margin as observed with the explorer. No pigmentation anywhere on the margin.The surface of the restoration is unaltered. Bravo: Evidence of a crevice along the margin, but the explorer cannot penetrate.Pigmentation present but does not penetrate along the margin toward the pulp. The surface of the restoration shows wear, and must be controlled. Charlie: Evidence of a crevice along the margin, into which an explorer can penetrate. Requires control, repair or retreatment. Severe pigmentation. The restoration must be removed. The surface of the restoration shows perforations, fractures or significant tear. It must be polished, repaired or retreated.
1 secondary outcome
Change in the Retention Status.
Time frame: At 6 months, 12 months, 18 months, and 24 months following application.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2021.
- 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.
Roqaia M Alassar, DDS principal investigator
Fixed Prosthodontist, Faculty of Dental Medicine for Girls, Al-Azhar University
Heba Abdelkafy, DDS principal investigator
Endodontist, Faculty of Dental Medicine for Girls, Al-Azhar University
Eman Abdelraouf, DDS principal investigator
Pedodontist, Faculty of Dental Medicine for Girls, Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endocrown group in people with Endodontically Treated Teeth and Permanent Molars, run by Al-Azhar University at 1 site in Egypt.
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 8 inclusion and 3 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: finished, as of the sponsor's last update on 28 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in marginal adaptation, discoloration and surface of the restoration. (time frame: At 6 months, 12 months, 18 months, and 24 months following application.). 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 28 Dec 2021.