Composite PostNCT06740643
Evaluation of Intracanal Reinforcement with Short Composite Post in Upper Primary Incisors with Severly Carious Teeth As in Early Childhood Caries Cases Using Randomized Clinical Trial
A study testing intracanal reinforcement using short composite post and no intracanal reinforcement in people with Composite Post and Intracanal Reinfocement, run by Cairo University.
Trial summary
Severely damaged incisors may lead to difficulty in speech, decreased masticatory efficiency, abnormal tongue habits, subsequent malocclusions, and psychological and self-esteem problems. There are several methods mentioned in the literature for the restoration of severely decayed primary anterior teeth. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Composite Post, Intracanal Reinfocement
- What is being tested?
- intracanal reinforcement using short composite post and no intracanal reinforcement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children Criteria:
- Medically free.
- Cooperative patient.
- Age (3 - 5 years)
- Incisors criteria:
- Upper primary incisors show large carious lesions.
- Radiographic criteria:
- No evidence of internal/external pathologic root resorption.
Who cannot join
- • Uncooperative children.
- Children with systemic disease.
- Refusal of participation in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Ahmed O Abdel Azeem, B.Sc(2018)Faculty of dentistry contact
About this study
Official title: Evaluation of Intracanal Reinforcement with Short Composite Post in Upper Primary Incisors: Randomized Clinical Trial
Severely damaged incisors may lead to difficulty in speech, decreased masticatory efficiency, abnormal tongue habits, subsequent malocclusions, and psychological and self-esteem problems. There are several methods mentioned in the literature for the restoration of severely decayed primary anterior teeth. The benefits of pulp therapy include: removing cavitations or defects to eliminate areas that are susceptible to caries; stopping the progression of tooth demineralization; restoring the integrity of tooth structure; preventing the spread of infection and preventing the shifting of teeth due to loss of tooth structure. The risks of pulp therapy include lessening the longevity of teeth by making them more susceptible to fracture as after removal of gross caries lesion and gaining access to the pulp the tooth become too weak, recurrent lesions, restoration failure, complications, and iatrogenic damage to adjacent teeth.
There are different techniques can be used for gaining intracanal retention in primary teeth. one of these techniques is resin composite posts.
Read more
Composite post restorations have been in used in primary teeth from 1986. They yield satisfactory results when there is normal masticatory function, a balanced diet, and hygiene control.
The evidence to support any method of intracanal reinforcement for restoring grossly broken down anterior teeth is presently lacking.
This study aims to Evaluate the intracanal reinforcement with short composite post in upper primary incisors versus no reinforcement.
- Conditions
- Composite Post, Intracanal Reinfocement
- Being tested
- intracanal reinforcement using short composite post, no intracanal reinforcement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intracanal reinforcement using short composite postProcedure or surgery
after pupectomy is done flowable composite will be applied 3mm intacanal to make a short compsite post before zircon crown aplicaction
no intracanal reinforcementProcedure or surgery
no intracanal reinforcement using resin modified glass ionmer before zircon crown application
| Study group | Role | What they receive |
|---|---|---|
| intracanal reinforcement with short compsite post | Experimental | Not described Receives: Procedure: intracanal reinforcement using short composite post |
| no intracanal reinforcement | Active comparator | Not described Receives: Procedure: no intracanal reinforcement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crown success
binary ( presence or abscence of the zircon crown)
Measured: 1 year
Secondary outcomes (2)
Clinically :Gingival health.
- A: No obvious sign of inflammation.
- B: Mild marginal gingivitis - tissue slightly reddened and edematous.
- C: Moderate marginal gingivitis - tissue obviously reddened and edematous.
- D: Sever gingivitis - tissue is very sollowen: spontaneous bleeding.
Measured: 1 year
Radiographic assessment.
- A: Healthy no pathosis noted.
- B: Pathosis apparent but not requiring immediate treatment.
- C: Pathosis apparent requiring immediate treatment.
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 posted18 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Composite PostStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Osama Abdelazeem, Cairo University
- Investigators
- Rana T Brtaw, Lecturer, Study director, Cairo UniversityAhmed H Elkadem, professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06740643
- Sponsor's protocol ID
- intracanal reinforcement
- Status last verified
- Dec 2024
- First submitted
- 14 Dec 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Intracanal Reinforcement with Short Composite Post in Upper Primary Incisors: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06740643
- Acronym / sponsor ID
- intracanal reinforcement
- Conditions
- Composite Post, Intracanal Reinfocement
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 18 Dec 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.
Severely damaged incisors may lead to difficulty in speech, decreased masticatory efficiency, abnormal tongue habits, subsequent malocclusions, and psychological and self-esteem problems. There are several methods mentioned in the literature for the restoration of severely decayed primary anterior teeth. The benefits of pulp therapy include: removing cavitations or defects to eliminate areas that are susceptible to caries; stopping the progression of tooth demineralization; restoring the integrity of tooth structure; preventing the spread of infection and preventing the shifting of teeth due to loss of tooth structure. The risks of pulp therapy include lessening the longevity of teeth by making them more susceptible to fracture as after removal of gross caries lesion and gaining access to the pulp the tooth become too weak, recurrent lesions, restoration failure, complications, and iatrogenic damage to adjacent teeth.
There are different techniques can be used for gaining intracanal retention in primary teeth. one of these techniques is resin composite posts.
Composite post restorations have been in used in primary teeth from 1986. They yield satisfactory results when there is normal masticatory function, a balanced diet, and hygiene control.
The evidence to support any method of intracanal reinforcement for restoring grossly broken down anterior teeth is presently lacking.
This study aims to Evaluate the intracanal reinforcement with short composite post in upper primary incisors versus no reinforcement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intracanal reinforcement with short compsite post | Experimental | Procedure: intracanal reinforcement using short composite post |
| no intracanal reinforcement | Active comparator | Procedure: no intracanal reinforcement |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Children Criteria:
- Upper primary incisors show large carious lesions.
- No evidence of internal/external pathologic root resorption.
Key exclusion criteria (3 listed)
- • Uncooperative children.
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 |
|---|---|---|
| intracanal reinforcement using short composite postafter pupectomy is done flowable composite will be applied 3mm intacanal to make a short compsite post before zircon crown aplicaction | Procedure or surgery | intracanal reinforcement with short compsite post |
| no intracanal reinforcementno intracanal reinforcement using resin modified glass ionmer before zircon crown application | Procedure or surgery | no intracanal reinforcement |
Primary outcome
Crown success
Time frame: 1 year
binary ( presence or abscence of the zircon crown)
2 secondary outcomes
Clinically :Gingival health.
Time frame: 1 year
Radiographic assessment.
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
Ahmed O Abdel Azeem, B.Sc(2018)Faculty of dentistry contact
Rana T Brtaw, Lecturer study director
Cairo University
Ahmed H Elkadem, professor study chair
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing intracanal reinforcement using short composite post and no intracanal reinforcement in people with Composite Post and Intracanal Reinfocement, 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 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: opening soon, as of the sponsor's last update on 18 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed O Abdel Azeem, B.Sc(2018)Faculty of dentistry (0201145611843, ahmed.abdelazeem@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Crown success (time frame: 1 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 18 Dec 2024.