Clinical Performance of Composite Coronal Build -Up in Mutilated Primary Incisors: 3 Years Results

NCT04758221 | Completed

• 1 other identifier: 41720
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective single arm study was to evaluate the clinical success and/ or failure of resin-bonded composite coronal build-up retained by macro-retentive grooves for restoring mutilated primary maxillary incisors after 36 months. Design: Forty two primary incisors out of 14 children, aged 2-5years, treated in a private pediatric dental practice under general anesthesia and presented for follow-up after 6, 12, 18, 24 and 36 months included in the study. The parameters recorded at the baseline and at the follow-up intervals were: retention, colour match, the number and location of the decayed surfaces (recurrent caries), chipping /fracture of the restoration and loss of restoration (failure). Materials and Methods: A total of (14) pediatric patients aged from 2-5 years presented with mutilated primary anterior teeth due to caries or trauma and treated comprehensively under general anesthesia from June 2016 to June 2017 were enrolled in this study. A total of (42) decayed or traumatized primary anterior teeth were treated with composite coronal build-up based on the micro-mechanical adhesive procedure of composite resin in addition to macro mechanical retentive grooves created on the lateral sides of the cervical one third of the roots of treated teeth. The patients returned at the end of 6, 12, 18, 24 and 36 months and received clinical examinations. Another dentist (co-author) who did not attend the treatment evaluated the strip crowns clinically by modified United States Public Health Service (USPHS) criteria.

Conditions

Early Childhood Caries; Pediatric Disease; Dental Caries; Dental Diseases

Keywords

Child; Esthetics; Dental caries; Primary incisors; Composite

Outcome Measures

Primary Outcomes (1)

• Evaluation of the clinical performance of composite strip crowns.

  Evaluation of the clinical performance of composite strip crowns. By Clinical photographs.

  36 months

Secondary Outcomes (1)

• Assessment of success and failure of the composite coronal build-up after 3 years follow-up.

  36 months

Study Arms (1)

Single arm : Composite coronal build up strip crown

EXPERIMENTAL

A total of (42) decayed or traumatized primary anterior teeth were treated with composite coronal build-up based on the micromechanical adhesive procedure of composite resin in addition to macro mechanical retentive grooves created on the lateral sides of the cervical one third of the roots of treated teeth.

Other: Treatment by composite coronal build-up

Interventions

Treatment by composite coronal build-up OTHER

A total of (42) decayed or traumatized primary anterior teeth were treated with composite coronal build-up based on the micromechanical adhesive procedure of composite resin in addition to macro mechanical retentive grooves created on the lateral sides of the cervical one third of the roots of treated teeth.

Single arm : Composite coronal build up strip crown

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Only children in the age group of 2-5 years.
• Teeth affected due to caries or trauma with one or two or three surfaces affected or more.

You may not qualify if:

• Any tooth nearing exfoliation or not fit for restoration.
• Patients with systemic problems which may interfere with general anesthesia.
• Teeth with excessive pathologic mobility.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Unknown Facility

Cairo, 0022, Egypt

Location

MeSH Terms

Conditions

Dental Caries; Stomatognathic Diseases

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases

Study Officials

• Rania Nasr, Assoc. Prof.

  Faculty of Dentistry, Cairo University, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Dr. Rania Nasr

Study Record Dates

• First Submitted: February 12, 2021
• First Posted: February 17, 2021
• Study Start: June 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: July 1, 2020
• Last Updated: February 17, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)