Comparing Different Types of Restorations for Restoring Endodontically Treated Permanent First Molar in ChildrenNCT06432049
Endocrown Restoring First Permanent Molar in Children
A study testing restoration for endodontically treated molar in people with Comparing Different Types of Restorations for Restoring Endodontically Treated Permanent First Molar in Children, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
Clinical and radiographic evaluation of endodontically treated first permanent molars in thirty children restored with three different restorations over 12 months Read more about this study
- Who is it for?
- Ages 10 to 13 years
- Conditions the study is for
- Comparing Different Types of Restorations for Restoring Endodontically Treated Permanent First Molar in Children
- What is being tested?
- restoration for endodontically treated molar
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Dec 2022to 13 May 2024
- 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 10 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient age ranging from 10-13 years old with closed apex.
- Normal occlusion without any para-functional habits.
- Decayed lower first molar.
- Supra-gingival margin was required after preparation.
- Absence of root fractures or cracks.
Who cannot join
- Difficulty to apply rubber dam for proper endocrown bonding.
- Lack of patient cooperation for post-operative recall and follow up.
- Bad oral hygiene
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Outcome of Endocrown Restoring First Permanent Molar in Children: Clinical Randomized Study
Clinical and radiographic evaluation of endodontically treated first permanent molars in thirty children restored with three different restorations over 12 months
Read the detailed description
This study comprised 30 children, with age range of (10-13) years old, with endodontically treated first permanent molars. Participants were classified into three groups according to type and material of the final restoration. All selected children were assigned to either PMC group (n=10) restored with performed metal crowns (Stainless-steel Molar Crowns) , EMX group (n=10) endocrown fabricated from CAD-CAM lithium disilicate glass ceramic , COP group (n=10) endocrown fabricated from CAD-CAM reinforced composite. After cementation, all children were evaluated over one year; at one week post-operative, 6 and 12 months for the following criteria: radiographic findings, plaque index, periodontal index, parent satisfaction.
- Being tested
- restoration for endodontically treated molar
- Keywords
- Endocrown, CAD-CAM, Children, Ceramic, Molars
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
restoration for endodontically treated molarOther
prefabricated stainless steel crown or endocrown
| Study group | Role | What they receive |
|---|---|---|
| PMC | Experimental | endodontically treated molar restored with Stainless steel crown Receives: Other: restoration for endodontically treated molar |
| EMX | Experimental | endodontically treated molar restored with endocrown fabricated from CAD-CAM lithium disillicate Receives: Other: restoration for endodontically treated molar |
| COP | Experimental | endodontically treated molar restored with endocrown fabricated from CAD-CAM composite Receives: Other: restoration for endodontically treated molar |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of participants with pathological changes in radiographs
periodical radiograph was used to evaluate all 30 participants for recurrent caries or periapical pathologic findings
Measured: 6 months
degree of parent satisfaction with different restorations
evaluation of the extent of parent satisfaction with different type of restorations using a special scale; Each reponse was scored as follows; (5) strongly agree, (4) agree (3) neutral, (2) disagree and (1) strongly disagree.
Measured: 6 month
rate of plaque accumulation on different type of restorations
plaque index evaluate the plaque accumulation around different type of restorations. this index involves:
- Plaque index 0: No plaque is in the area adjacent to the gingiva.
- Plaque index 1: There is a plaque in the form of a thin film on the gingival margin.
- Plaque index 2: There is a visible plaque in the gingival pocket and gingival margin.
- Plaque index 3: There is a dense plaque in the gingival pocket and on the gingival margin.
Measured: 6 months
effect of different restoration on surrounding gingiva
gingival index was used to evaluate the gingival health surrounding restorationsThis index involves a scale from 0 to 3 for the buccal, lingual, mesial and distal surfaces that is scored as follows: 0 indicates healthy gums; 1 indicates slight color changes, light edema and no presence of bleeding on probing; 2 indicates edema with slight redness and bleeding on probing; and 3 indicates severe edema, redness, the presence of ulceration and a tendency for spontaneous bleeding.
Measured: 6 months
Secondary outcomes (4)
number of participants with pathological changes in radiographs
periodical radiograph was used to evaluate all 30 participants for recurrent caries or periapical pathologic findings
Measured: 1 year
degree of parent satisfaction with different restorations
using a special scale; Each reponse was scored as follows; (5) strongly agree, (4) agree (3) neutral, (2) disagree and (1) strongly disagree.
Measured: 1 year
rate of plaque accumulation on different type of restorations
plaque index evaluate the plaque accumulation around different type of restorations. this index involves:
- Plaque index 0: No plaque is in the area adjacent to the gingiva.
- Plaque index 1: There is a plaque in the form of a thin film on the gingival margin.
- Plaque index 2: There is a visible plaque in the gingival pocket and gingival margin.
- Plaque index 3: There is a dense plaque in the gingival pocket and on the gingival margin.
Measured: 1 year
effect of different restoration on surrounding gingiva
gingival index was used to evaluate the gingival health surrounding restorationsThis index involves a scale from 0 to 3 for the buccal, lingual, mesial and distal surfaces that is scored as follows: 0 indicates healthy gums; 1 indicates slight color changes, light edema and no presence of bleeding on probing; 2 indicates edema with slight redness and bleeding on probing; and 3 indicates severe edema, redness, the presence of ulceration and a tendency for spontaneous bleeding.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start5 Dec 2022
- Primary completion9 Nov 2023
- Study completion13 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Comparing Different Types of Restorations for Restoring Endodontically Treated Permanent First Molar in ChildrenStudies of the same condition, open and under way.
- 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
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Ismail Taha, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06432049
- Sponsor's protocol ID
- MKSU/22-11-4
- Status last verified
- May 2024
- First submitted
- 16 May 2024
- Last updated
- 29 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: all data will be shared after publishing.
Publications
Taha AI, Saad AE. Clinical and radiographic outcomes of endocrowns fabricated from two different CAD-CAM materials versus stainless steel crowns in restoring first permanent molars in children: a randomized clinical trial. BMC Oral Health. 2025 Jul 8;25(1):1127. doi: 10.1186/s12903-025-06507-z.
PubMed 40629344
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Outcome of Endocrown Restoring First Permanent Molar in Children: Clinical Randomized Study
- ClinicalTrials.gov ID
- NCT06432049
- Acronym / sponsor ID
- MKSU/22-11-4
- Keywords
- Endocrown, CAD-CAM, Children, Ceramic, Molars
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 5 Dec 2022 (actual)
- Primary completion
- 9 Nov 2023 (actual)
- Study completion
- 13 May 2024 (actual)
- First posted
- 29 May 2024 (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.
Clinical and radiographic evaluation of endodontically treated first permanent molars in thirty children restored with three different restorations over 12 months
Detailed description
This study comprised 30 children, with age range of (10-13) years old, with endodontically treated first permanent molars. Participants were classified into three groups according to type and material of the final restoration. All selected children were assigned to either PMC group (n=10) restored with performed metal crowns (Stainless-steel Molar Crowns) , EMX group (n=10) endocrown fabricated from CAD-CAM lithium disilicate glass ceramic , COP group (n=10) endocrown fabricated from CAD-CAM reinforced composite. After cementation, all children were evaluated over one year; at one week post-operative, 6 and 12 months for the following criteria: radiographic findings, plaque index, periodontal index, parent satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PMC | Experimental | Other: restoration for endodontically treated molarendodontically treated molar restored with Stainless steel crown |
| EMX | Experimental | Other: restoration for endodontically treated molarendodontically treated molar restored with endocrown fabricated from CAD-CAM lithium disillicate |
| COP | Experimental | Other: restoration for endodontically treated molarendodontically treated molar restored with endocrown fabricated from CAD-CAM composite |
Who may qualify
- Ages
- 10 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Patient age ranging from 10-13 years old with closed apex.
- Normal occlusion without any para-functional habits.
- Decayed lower first molar.
- Supra-gingival margin was required after preparation.
- Absence of root fractures or cracks.
Key exclusion criteria (3 listed)
- Difficulty to apply rubber dam for proper endocrown bonding.
- Lack of patient cooperation for post-operative recall and follow up.
- Bad oral hygiene
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 |
|---|---|---|
| restoration for endodontically treated molarprefabricated stainless steel crown or endocrown | Other | COP, EMX, PMC |
Primary outcome
number of participants with pathological changes in radiographs
Time frame: 6 months
periodical radiograph was used to evaluate all 30 participants for recurrent caries or periapical pathologic findings
degree of parent satisfaction with different restorations
Time frame: 6 month
evaluation of the extent of parent satisfaction with different type of restorations using a special scale; Each reponse was scored as follows; (5) strongly agree, (4) agree (3) neutral, (2) disagree and (1) strongly disagree.
rate of plaque accumulation on different type of restorations
Time frame: 6 months
plaque index evaluate the plaque accumulation around different type of restorations. this index involves: * Plaque index 0: No plaque is in the area adjacent to the gingiva. * Plaque index 1: There is a plaque in the form of a thin film on the gingival margin. * Plaque index 2: There is a visible plaque in the gingival pocket and gingival margin. * Plaque index 3: There is a dense plaque in the gingival pocket and on the gingival margin.
effect of different restoration on surrounding gingiva
Time frame: 6 months
gingival index was used to evaluate the gingival health surrounding restorationsThis index involves a scale from 0 to 3 for the buccal, lingual, mesial and distal surfaces that is scored as follows: 0 indicates healthy gums; 1 indicates slight color changes, light edema and no presence of bleeding on probing; 2 indicates edema with slight redness and bleeding on probing; and 3 indicates severe edema, redness, the presence of ulceration and a tendency for spontaneous bleeding.
4 secondary outcomes
number of participants with pathological changes in radiographs
Time frame: 1 year
degree of parent satisfaction with different restorations
Time frame: 1 year
rate of plaque accumulation on different type of restorations
Time frame: 1 year
effect of different restoration on surrounding gingiva
Time frame: 1 year
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 29 May 2024.
- Derived from this study: PubMed 40629344Taha AI, Saad AE. Clinical and radiographic outcomes of endocrowns fabricated from two different CAD-CAM materials versus stainless steel crowns in restoring first permanent molars in children: a randomized clinical trial. BMC Oral Health. 2025 Jul 8;25(1):1127. doi: 10.1186/s12903-025-06507-z.
- Individual participant dataSharing planned: Undecided. all data will be shared after publishing.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing restoration for endodontically treated molar in people with Comparing Different Types of Restorations for Restoring Endodontically Treated Permanent First Molar in Children, 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 5 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 29 May 2024. 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?
number of participants with pathological changes in radiographs (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06432049, which also lists 1 linked publication.
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 29 May 2024; AzTrials last refreshed its copy on 31 Oct 2026.