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

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.

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 Overview

• Status: Not yet recruiting
• Conditions: Composite Post; Intracanal Reinfocement
• Intervention / Treatment: Procedure: intracanal reinforcement using short composite post; Procedure: no intracanal reinforcement

• Study Type: Interventional
• Enrollment (Estimated): 62
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed O Abdel Azeem, B.Sc(2018)Faculty of dentistry; Phone Number: 0201145611843; Email: ahmed.abdelazeem@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intracanal reinforcement with short compsite post	Procedure: intracanal 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
Active Comparator: no intracanal reinforcement	Procedure: no intracanal reinforcement; no intracanal reinforcement using resin modified glass ionmer before zircon crown application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Crown success	binary ( presence or abscence of the zircon crown)	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year
Radiographic assessment.	A: Healthy no pathosis noted.; B: Pathosis apparent but not requiring immediate treatment.; C: Pathosis apparent requiring immediate treatment.	1 year

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Rana T Brtaw, Lecturer, Cairo University; Study Chair: Ahmed H Elkadem, professor, Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: December 14, 2024
• First Submitted That Met QC Criteria: December 14, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 14, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: intracanal reinforcement

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No