Dental Caries in ChildrenNCT05250609
Clinical and Radiographic Evaluation of Resin Endocrown as Long Term Interim Restoration Versus Stainless Steel Crown for Endodontically Treated First Permanent Molar in Children: Randomized Controlled Pilot Study.
A study testing Endocrown "composite". in people with Dental Caries in Children, run by Cairo University at 1 site in Egypt.
Trial summary
management of endodontically treated first permanent molar with deep dental caries is one of the challenging procedure that the operator face. Using resin endocrown or stainless steel crown restoration to make comparison which one is more successful in children. Read more about this study
- Who is it for?
- Ages 10 to 13 years
- Conditions the study is for
- Dental Caries in Children
- What is being tested?
- Endocrown "composite".
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2022to 30 Sep 2023
- 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
- Cooperative children in age range from 10 to 13 years
- Mandibular first permanent molar indicated for root canal treatment with closed apex.
- Presence of at least two to three sound walls of tooth.
- Absence of internal or external pathologic root resorption.
- Normal occlusion without any para-functional habits.
- Parent or guardian agree for participant in the study
Who cannot join
- Excessive mobility.
- Children with underlying systemic disease.
- Children with special health care needs.
- Poor oral hygiene.
Trial locations and contacts
1 site in 1 country.
About this study
management of endodontically treated first permanent molar with deep dental caries is one of the challenging procedure that the operator face. Using resin endocrown or stainless steel crown restoration to make comparison which one is more successful in children.
Read the detailed description
Diagnostic procedure:
Diagnosis of the cases will be performed according to guidelines of AAPD 2017 for treatment of irreversible pulpitis and necrotic pulp therapy in mandibular first permanent molar . Preoperative periapical radiograph will be taken
Intra operative procedure:
Local anaesthesia administration using articaine 4% with epinephrine 1:100000. Rubber dam application and access cavity preparation will be established using a sterile bur. Root Canal Treatment will be done and then the dental orifices of the pulp chamber will be sealed using a flowable composite.
The immediate postoperative radiograph will be done to reveal optimal root canal treatment.
In the intervention group:
The preparation of cavity design will be as following:
Preparation of occlusal surface will be done with wheel stone to create 2 mm occlusal clearance; the occlusal surface will be prepared flat to create a butt-joint. The junction between the occlusal and mesial cavity will be rounded to produce cervical side walk. • Divergence of the inner cavity walls will be obtained using a tapered stone with a rounded end (TR- Dia Bur Mani).
Impression will be taken for the prepared tooth structure using addition silicone material (Elite HD Zermach, Italy), stone model will be poured for fabrication of endocrown to allow for blockage of any undercuts in the pulp chamber cavity. Finished final endocrown restoration will be cemented in place using self-adhesive universal dual cured resin cement (rely X Unicem, 3M, USA).
In the control group tooth preparation will be made as follow:
By reducing mesial, distal and occlusal surface. The crown margin will be placed just apically to the gingival margin and carefully adjusted to give an accurate fit in this region. The crown will be cemented with glass ionomer cement.
Follow up:
Clinical and evaluation will be performed at 1 st week, 3, 6, 9 and 12 months. Radiograph evaluation will be performed at, 1 st week, 6 and 12 months
- Conditions
- Dental Caries in Children
- Being tested
- Endocrown "composite".
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endocrown "composite".Other
It is a type of restoration has been shown a great success in adult and recently has been suggested for children
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Endocrown "composite". | Experimental | Composite Endocrown will be used as an extra-coronal restoration in endodontically treated mutilated first permanent molar Receives: Other: Endocrown "composite". |
| Comparator / Control: Stainless steel crown. | No intervention | Stainless steel crown will be used as an extra-coronal restoration in endodontically treated mutilated first permanent molar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Will be recorded by using modified wong-baker pain scale (0 -3). Zero= no pain, 1= slight pain, 2=moderate pain, 3= severe pain. Principle investigator will ask the patient about the pain.
Measured: one year
Gingival bleeding
Gingival Index(GI)Scale (0-3): score 0: normal gingiva, score1: mild inflammation, slight change in colour, slight oedema, no bleeding on probing, score2: moderate inflammation, redness, oedema, and glazing, bleeding on probing, score3: severe inflammation, marked redness and oedema, ulceration tendency to spontaneous bleeding.
Measured: one year
Retention
Clinical evaluation by Principle investigator. Binary (Yes/No)
Measured: one year
Patient satisfaction
Patient and guardian satisfaction with restorative treatment was classified as (score from 1-4) 1= very dissatisfied, 2= dissatisfied, 3= satisfied and 4= very satisfied
Measured: one year
Probing pocket depth (PPD)
Periodontal probe. (1-5 mm):It will be measured in mesiobuccal, distobuccal, mesiolingual, and distolingual areas. The periodontal probe will be inserted into the gingival sulcus parallel to the longitudinal axis of the tooth and will be moved in a walking fashion.
Measured: one year
Secondary outcomes (1)
Radiograph in Terms of root fracture
Digital radiographic Evaluation. Binary(Yes/No)
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 Feb 2022
- Study start1 Aug 2022
- Primary completion31 Aug 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dental Caries in ChildrenStudies 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
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basheer Ali Mabkhot, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05250609
- Sponsor's protocol ID
- 14422021510951
- Status last verified
- Sep 2023
- First submitted
- 5 Feb 2022
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mabkhot BA, Taha SEE, Kamel MH, Sabry SM. Periodontal health of endodontically treated molars restored with composite CAD/CAM endocrowns versus stainless steel crowns in Egyptian children: a randomized controlled trial. BMC Oral Health. 2026 Apr 18;26(1):985. doi: 10.1186/s12903-026-08077-0.
PubMed 42010592Mabkhot BA, Taha SEE, Sabry SM. Clinical and radiographic assessment of composite CAD/CAM endocrowns and stainless steel crowns for endodontically treated first permanent molars in Egyptian children: randomized controlled pilot study. BMC Oral Health. 2025 May 31;25(1):864. doi: 10.1186/s12903-025-06192-y.
PubMed 40450229
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Resin Endocrown as Long Term Interim Restoration Versus Stainless Steel Crown for Endodontically Treated First Permanent Molar in Children: Randomized Controlled Pilot Study.
- ClinicalTrials.gov ID
- NCT05250609
- Acronym / sponsor ID
- 14422021510951
- Conditions
- Dental Caries in Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 22 Feb 2022 (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.
management of endodontically treated first permanent molar with deep dental caries is one of the challenging procedure that the operator face. Using resin endocrown or stainless steel crown restoration to make comparison which one is more successful in children.
Detailed description
Diagnostic procedure:
Diagnosis of the cases will be performed according to guidelines of AAPD 2017 for treatment of irreversible pulpitis and necrotic pulp therapy in mandibular first permanent molar . Preoperative periapical radiograph will be taken
Intra operative procedure:
Local anaesthesia administration using articaine 4% with epinephrine 1:100000. Rubber dam application and access cavity preparation will be established using a sterile bur. Root Canal Treatment will be done and then the dental orifices of the pulp chamber will be sealed using a flowable composite.
The immediate postoperative radiograph will be done to reveal optimal root canal treatment.
In the intervention group:
The preparation of cavity design will be as following:
Preparation of occlusal surface will be done with wheel stone to create 2 mm occlusal clearance; the occlusal surface will be prepared flat to create a butt-joint. The junction between the occlusal and mesial cavity will be rounded to produce cervical side walk. • Divergence of the inner cavity walls will be obtained using a tapered stone with a rounded end (TR- Dia Bur Mani).
Impression will be taken for the prepared tooth structure using addition silicone material (Elite HD Zermach, Italy), stone model will be poured for fabrication of endocrown to allow for blockage of any undercuts in the pulp chamber cavity. Finished final endocrown restoration will be cemented in place using self-adhesive universal dual cured resin cement (rely X Unicem, 3M, USA).
In the control group tooth preparation will be made as follow:
By reducing mesial, distal and occlusal surface. The crown margin will be placed just apically to the gingival margin and carefully adjusted to give an accurate fit in this region. The crown will be cemented with glass ionomer cement.
Follow up:
Clinical and evaluation will be performed at 1 st week, 3, 6, 9 and 12 months. Radiograph evaluation will be performed at, 1 st week, 6 and 12 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention: Endocrown "composite". | Experimental | Other: Endocrown "composite".Composite Endocrown will be used as an extra-coronal restoration in endodontically treated mutilated first permanent molar |
| Comparator / Control: Stainless steel crown. | No intervention | –Stainless steel crown will be used as an extra-coronal restoration in endodontically treated mutilated first permanent molar |
Who may qualify
- Ages
- 10 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Cooperative children in age range from 10 to 13 years
Key exclusion criteria (4 listed)
- Excessive mobility.
- Children with underlying systemic disease.
- Children with special health care needs.
- Poor 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 |
|---|---|---|
| Endocrown "composite".It is a type of restoration has been shown a great success in adult and recently has been suggested for children | Other | Intervention: Endocrown "composite". |
Primary outcome
Postoperative pain
Time frame: one year
Will be recorded by using modified wong-baker pain scale (0 -3). Zero= no pain, 1= slight pain, 2=moderate pain, 3= severe pain. Principle investigator will ask the patient about the pain.
Gingival bleeding
Time frame: one year
Gingival Index(GI)Scale (0-3): score 0: normal gingiva, score1: mild inflammation, slight change in colour, slight oedema, no bleeding on probing, score2: moderate inflammation, redness, oedema, and glazing, bleeding on probing, score3: severe inflammation, marked redness and oedema, ulceration tendency to spontaneous bleeding.
Retention
Time frame: one year
Clinical evaluation by Principle investigator. Binary (Yes/No)
Patient satisfaction
Time frame: one year
Patient and guardian satisfaction with restorative treatment was classified as (score from 1-4) 1= very dissatisfied, 2= dissatisfied, 3= satisfied and 4= very satisfied
Probing pocket depth (PPD)
Time frame: one year
Periodontal probe. (1-5 mm):It will be measured in mesiobuccal, distobuccal, mesiolingual, and distolingual areas. The periodontal probe will be inserted into the gingival sulcus parallel to the longitudinal axis of the tooth and will be moved in a walking fashion.
1 secondary outcome
Radiograph in Terms of root fracture
Time frame: one 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 3 Oct 2023.
- Derived from this study: PubMed 42010592Mabkhot BA, Taha SEE, Kamel MH, Sabry SM. Periodontal health of endodontically treated molars restored with composite CAD/CAM endocrowns versus stainless steel crowns in Egyptian children: a randomized controlled trial. BMC Oral Health. 2026 Apr 18;26(1):985. doi: 10.1186/s12903-026-08077-0.
- Derived from this study: PubMed 40450229Mabkhot BA, Taha SEE, Sabry SM. Clinical and radiographic assessment of composite CAD/CAM endocrowns and stainless steel crowns for endodontically treated first permanent molars in Egyptian children: randomized controlled pilot study. BMC Oral Health. 2025 May 31;25(1):864. doi: 10.1186/s12903-025-06192-y.
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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.
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 "composite". in people with Dental Caries in Children, run by Cairo 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 6 inclusion and 4 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 3 Oct 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.
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?
Postoperative pain (time frame: one year). The study lists 5 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 NCT05250609, which also lists 2 linked publications.
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 3 Oct 2023.