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Not yet recruitingNCT06740643Updated Dec 18, 2024

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

An interventional study of intracanal reinforcement using short composite post and no intracanal reinforcement in Composite Post and Intracanal Reinfocement, sponsored by Cairo University. Not yet recruiting. Open to participants aged 3 Years to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-18.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jan 2026, 9 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
3 Years to 5 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Composite Post
  • Intracanal Reinfocement
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 5 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

    • Uncooperative children.

      • Children with systemic disease.
      • Refusal of participation in the study.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
62 participants (estimated)

Study arms

  • Experimental
    intracanal reinforcement with short compsite post

    Procedure: intracanal reinforcement using short composite post

  • Active comparator
    no intracanal reinforcement

    Procedure: no intracanal reinforcement

Interventions

  • Procedureintracanal reinforcement using short composite post

    after pupectomy is done flowable composite will be applied 3mm intacanal to make a short compsite post before zircon crown aplicaction

  • Procedureno intracanal reinforcement

    no intracanal reinforcement using resin modified glass ionmer before zircon crown application

06

What researchers measure

Primary outcomes

  1. Crown success

    binary ( presence or abscence of the zircon crown)

    Time frame: 1 year

Secondary outcomes

  1. 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.

    Time frame: 1 year

  2. Radiographic assessment.

    * A: Healthy no pathosis noted. * B: Pathosis apparent but not requiring immediate treatment. * C: Pathosis apparent requiring immediate treatment.

    Time frame: 1 year

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06740643
Lead sponsor
Cairo University
Responsible party
Ahmed Osama Abdelazeem (master's student at Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University., Cairo University) — Principal investigator
First posted
Dec 18, 2024
Start date
Jan 1, 2025 (estimated)
Primary completion
Jan 1, 2026 (estimated)
Completion
Apr 1, 2026 (estimated)
Last update
Dec 18, 2024

Study contacts

Ahmed O Abdel Azeem, B.Sc(2018)Faculty of dentistry
Contact
ahmed.abdelazeem@dentistry.cu.edu.eg
0201145611843
Rana T Brtaw, Lecturer
study director · Cairo University
Ahmed H Elkadem, professor
study chair · Cairo University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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