Endodontically Treated TeethPhase 2NCT05973292
Endocrowns in Anterior Teeth: Effect of Cementation Protocols and Restorative Materials on the Clinical Performance of the Restorations
A Phase 2 study testing resin cement containing phosphate ester monomer 10-methacryloyloxydecyl dihydrogen phosphate and Non MDP containg resin cement in people with Endodontically Treated Teeth and Anterior Teeth, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
Rehabilitation of anterior endodontically treated teeth with significant coronal damage has been problematic. Adopting endocrown design to treat teeth with this condition is still under investigation. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Endodontically Treated Teeth, Anterior Teeth
- What is being tested?
- resin cement containing phosphate ester monomer 10-methacryloyloxydecyl dihydrogen phosphate and Non MDP containg resin cement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2021to 1 Apr 2022
- Phase
- Phase 2
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Freshly extracted teeth.
- Completely formed apices
- Minimum root length of 14mm (± 0.5) measured from the cement-enamel junction to the root apex.
- Straight roots.
- Teeth with single root canal.
- Sound teeth with no cracks or fractured parts in its crown or root.
Show all 9Show fewer
- Absence of any carious lesions.
- No signs of internal or external root resorption.
- Similar bucco-lingual (BL) and mesio-distal (MD) dimensions as determined with a digital caliper.
Who cannot join
- • Previously endodontically treated teeth.
- Markedly curved roots.
- Root contains more than one canal.
- Presence of canal calcifications or pulp stones.
- Internal or external root resorption.
- Presence of cracks, fractures or caries.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry,Mansoura University
Al Mansurah, Dakahlia Governorate, 33516
About this study
Rehabilitation of anterior endodontically treated teeth with significant coronal damage has been problematic. Adopting endocrown design to treat teeth with this condition is still under investigation. To address this issue, the USPHS criteria were adopted to assess the anterior endocrown restorations manufactured using various ceramic materials and cemented with different protocols.
Read the detailed description
40 participants with anterior endodontically treated maxillary central incisors were enrolled to restore their teeth with esthetic restorations Patients were divided into two groups, zirconia and e-max groups. Each group was, further subdivided into two groups following the cementation protocol. Patients were evaluated immediately (baseline) and at. The clinical marginal accuracy measurements were carried out for all groups at baseline, 3, 6, 9, 12, and 18 months and evaluated by 3 investigators using Modified (USPHS). The patients' satisfaction and potential postoperative discomfort were also assessed and recorded during the same periods. All qualitative data were displayed as frequency (N) and Percentages (%). The chi-square test was utilized for qualitative data comparisons.
Results:
As to marginal integrity and patient satisfaction, no significant difference were revealed regarding all scores at different intervals as P>0.05.
Conclusions:
According to the findings of this study, ceramic endocrowns offer a promising restorative solution for the rehabilitation of anterior endodontically treated teeth. Additionally, regardless of the presence of the MDP monomer in its composition, using adhesive resin cement achieved highly successful results when used with MDP-based ceramic primers.
- Conditions
- Endodontically Treated Teeth, Anterior Teeth
- Being tested
- resin cement containing phosphate ester monomer 10-methacryloyloxydecyl dihydrogen phosphate, Non MDP containg resin cement
- Keywords
- Digital Dentistry, E-max, MDP, Zirconia
- Medical subject headings
- Tooth, Nonvital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resin cement containing phosphate ester monomer 10-methacryloyloxydecyl dihydrogen phosphateOther
Also called Panavia SA
Adhesive resin cement containing an MDP agent that is added to bonding agents to enhance bonding to ceramics like Ziconia and E-max
Non MDP containg resin cementOther
Also called Duo-link Universal
Adhesive resin cement not containing an MDP agent
| Study group | Role | What they receive |
|---|---|---|
| Group ZA | Experimental | Participants received Zirconia anterior endocrowns. Endocrowns were cemented with MDP-containing primer+ MDP-containing resin cement. Receives: Other: resin cement containing phosphate ester monomer 10-methacryloyloxydecyl dihydrogen phosphate |
| Ggroup ZB | Experimental | Participants received Zirconia anterior endocrowns. Endocrowns were cemented with MDP-containing primer+ Non-MDP-containing resin cement. Receives: Other: Non MDP containg resin cement |
| Group EA | Experimental | Participants received E-max anterior endocrowns. Endocrowns were cemented with MDP-containing primer+ MDP-containing resin cement. Receives: Other: resin cement containing phosphate ester monomer 10-methacryloyloxydecyl dihydrogen phosphate |
| Group EB | Experimental | Participants received E-max anterior endocrowns. Endocrowns were cemented with MDP-containing primer+ Non-MDP-containing resin cement. Receives: Other: Non MDP containg resin cement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal Integrity
Using a dental mirror and a dental explorer, endocrowns were checked from every aspect, buccal, mesial, distal and lingual to detect any marginal discontinuity, fractures, or gaps. Endocrown evaluation was carried out against The Modified USPHS criteria
Measured: 3-6-9-12 Months
Secondary outcomes (1)
Patient Satisfaction
Each patient was asked about his opinion regarding the restoration. Patients' answers and/or complaints were assessed and recorded against the USPHS criteria
Measured: 3-6-9-12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start1 Apr 2021
- Primary completion1 Apr 2022
- Study completion1 Apr 2022
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 Kafrelsheikh 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All patients received their treatment at the same time. Follow-up periods were parallel for all participants.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nehal Samra, Kafrelsheikh University
- Investigators
- Lamia Dawood, Professor, Study director, Professor of Fixed Prosthodontics, Faculty of Dentistry, Mansoura University, Mansoura, Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05973292
- Sponsor's protocol ID
- M01160321
- Status last verified
- Jul 2023
- First submitted
- 26 Jul 2023
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endocrowns in Anterior Teeth: Effect of Cementation Protocols and Restorative Materials on the Clinical Performance of the Restorations
- ClinicalTrials.gov ID
- NCT05973292
- Acronym / sponsor ID
- M01160321
- Conditions
- Endodontically Treated Teeth, Anterior Teeth
- Keywords
- Digital Dentistry, E-max, MDP, Zirconia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 2 Aug 2023 (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.
Rehabilitation of anterior endodontically treated teeth with significant coronal damage has been problematic. Adopting endocrown design to treat teeth with this condition is still under investigation. To address this issue, the USPHS criteria were adopted to assess the anterior endocrown restorations manufactured using various ceramic materials and cemented with different protocols.
Detailed description
40 participants with anterior endodontically treated maxillary central incisors were enrolled to restore their teeth with esthetic restorations Patients were divided into two groups, zirconia and e-max groups. Each group was, further subdivided into two groups following the cementation protocol. Patients were evaluated immediately (baseline) and at. The clinical marginal accuracy measurements were carried out for all groups at baseline, 3, 6, 9, 12, and 18 months and evaluated by 3 investigators using Modified (USPHS). The patients' satisfaction and potential postoperative discomfort were also assessed and recorded during the same periods. All qualitative data were displayed as frequency (N) and Percentages (%). The chi-square test was utilized for qualitative data comparisons.
Results:
As to marginal integrity and patient satisfaction, no significant difference were revealed regarding all scores at different intervals as P>0.05.
Conclusions:
According to the findings of this study, ceramic endocrowns offer a promising restorative solution for the rehabilitation of anterior endodontically treated teeth. Additionally, regardless of the presence of the MDP monomer in its composition, using adhesive resin cement achieved highly successful results when used with MDP-based ceramic primers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- All patients received their treatment at the same time. Follow-up periods were parallel for all participants.
| Arm | Type | Receives |
|---|---|---|
| Group ZA | Experimental | Other: resin cement containing phosphate ester monomer 10-methacryloyloxydecyl dihydrogen phosphateParticipants received Zirconia anterior endocrowns. Endocrowns were cemented with MDP-containing primer+ MDP-containing resin cement. |
| Ggroup ZB | Experimental | Other: Non MDP containg resin cementParticipants received Zirconia anterior endocrowns. Endocrowns were cemented with MDP-containing primer+ Non-MDP-containing resin cement. |
| Group EA | Experimental | Other: resin cement containing phosphate ester monomer 10-methacryloyloxydecyl dihydrogen phosphateParticipants received E-max anterior endocrowns. Endocrowns were cemented with MDP-containing primer+ MDP-containing resin cement. |
| Group EB | Experimental | Other: Non MDP containg resin cementParticipants received E-max anterior endocrowns. Endocrowns were cemented with MDP-containing primer+ Non-MDP-containing resin cement. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- • Freshly extracted teeth.
Key exclusion criteria (6 listed)
- • Previously endodontically treated teeth.
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 |
|---|---|---|
| resin cement containing phosphate ester monomer 10-methacryloyloxydecyl dihydrogen phosphateAlso: Panavia SAAdhesive resin cement containing an MDP agent that is added to bonding agents to enhance bonding to ceramics like Ziconia and E-max | Other | Group EA, Group ZA |
| Non MDP containg resin cementAlso: Duo-link UniversalAdhesive resin cement not containing an MDP agent | Other | Ggroup ZB, Group EB |
Primary outcome
Marginal Integrity
Time frame: 3-6-9-12 Months
Using a dental mirror and a dental explorer, endocrowns were checked from every aspect, buccal, mesial, distal and lingual to detect any marginal discontinuity, fractures, or gaps. Endocrown evaluation was carried out against The Modified USPHS criteria
1 secondary outcome
Patient Satisfaction
Time frame: 3-6-9-12 Months
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 2 Aug 2023.
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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.
Lamia Dawood, Professor study director
Professor of Fixed Prosthodontics, Faculty of Dentistry, Mansoura University, Mansoura, Egypt.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing resin cement containing phosphate ester monomer 10-methacryloyloxydecyl dihydrogen phosphate and Non MDP containg resin cement in people with Endodontically Treated Teeth and Anterior Teeth, run by Kafrelsheikh 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 9 inclusion and 6 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 2 Aug 2023. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Marginal Integrity (time frame: 3-6-9-12 Months). 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 2 Aug 2023.