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NCT Number: NCT06740643

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

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.

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Key information

Age range

3 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

intracanal reinforcement using short composite post

Procedure

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

no intracanal reinforcement

Procedure

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

Primary outcomes

  1. Crown success

    Time frame: 1 year

    binary ( presence or abscence of the zircon crown)

Secondary outcomes

  1. Clinically :Gingival health.

    Time frame: 1 year

    • 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.
  2. Radiographic assessment.

    Time frame: 1 year

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

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed O Abdel Azeem, B.Sc(2018)Faculty of dentistry

CONTACT

[email protected]

0201145611843

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Evaluation of Intracanal Reinforcement with Short Composite Post in Upper Primary Incisors: Randomized Clinical Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 18, 2024
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.