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

Clinical Performance of Composite Coronal Build -Up in Mutilated Primary Incisors: Prospective Single Arm Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04758221
Enrollment
14
Registered
2021-02-17
Start date
2016-06-30
Completion date
2020-07-31
Last updated
2021-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries, Dental Diseases, Early Childhood Caries, Pediatric Disease

Keywords

Child, Esthetics, Dental caries, Primary incisors, Composite

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.

Detailed description

Purpose: The purpose of this 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 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. 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. The USPHS system is primarily for posterior teeth, so a new system was developed for anterior teeth. The definitions and criteria for the rating system are detailed in Table (1). Briefly, it was a photographic examination including an evaluation of the color, shape, and integrity of the strip crown. All patients were recalled, and restorations were evaluated for anatomic form, surface texture, recurrent caries, color match and retention in accordance with Ryge's Direct (US Public Health Service) evaluation criteria at baseline (immediately postoperative), and intervals of 6, 12, 24, and 36 months. The crown was considered to be clinically successful, if the surface appeared smooth, the colour remained good or acceptable, without chipping/ fracture or recurrent caries at tooth/restoration interface and there is no loss of the restoration. Data are analyzed using percentages, frequencies and cumulative frequencies. The Z-test will be used for comparison between failure rates of the two types of failures (Failure due to trauma & failure of bonding), significance level is set at P\< 0·05. The Chi squared test will be used for association between the number of affected surfaces and the total failures. The level of significance (P-value) is set at P\< 0·05.

Interventions

OTHERTreatment by composite coronal build-up

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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 5 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of the clinical performance of composite strip crowns.36 monthsEvaluation of the clinical performance of composite strip crowns. By Clinical photographs.

Secondary

MeasureTime frameDescription
Assessment of success and failure of the composite coronal build-up after 3 years follow-up.36 monthsAssessment of success and failure of the composite coronal build-up after 3 years follow-up in terms of: * Retention * Color match * Recurrent Caries * Fracture/Chipping * Loss of restoration (Failure)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026