Clinical Performance of Composite Coronal Build -Up in Mutilated Primary Incisors: 3 Years Results
Primary Purpose
Early Childhood Caries, Pediatric Disease, Dental Caries
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Treatment by composite coronal build-up
Sponsored by
About this trial
This is an interventional treatment trial for Early Childhood Caries focused on measuring Child, Esthetics, Dental caries, Primary incisors, Composite
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single arm : Composite coronal build up strip crown
Arm Description
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.
Outcomes
Primary Outcome Measures
Evaluation of the clinical performance of composite strip crowns.
Evaluation of the clinical performance of composite strip crowns. By Clinical photographs.
Secondary Outcome Measures
Assessment of success and failure of the composite coronal build-up after 3 years follow-up.
Assessment 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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04758221
Brief Title
Clinical Performance of Composite Coronal Build -Up in Mutilated Primary Incisors: 3 Years Results
Official Title
Clinical Performance of Composite Coronal Build -Up in Mutilated Primary Incisors: Prospective Single Arm Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
July 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Childhood Caries, Pediatric Disease, Dental Caries, Dental Diseases
Keywords
Child, Esthetics, Dental caries, Primary incisors, Composite
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single arm : Composite coronal build up strip crown
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Treatment by composite coronal build-up
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluation of the clinical performance of composite strip crowns.
Description
Evaluation of the clinical performance of composite strip crowns. By Clinical photographs.
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Assessment of success and failure of the composite coronal build-up after 3 years follow-up.
Description
Assessment 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)
Time Frame
36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rania Nasr, Assoc. Prof.
Organizational Affiliation
Faculty of Dentistry, Cairo University, Egypt
Official's Role
Principal Investigator
Facility Information:
City
Cairo
ZIP/Postal Code
0022
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No sharing of any private data of participants with other researchers
Learn more about this trial
Clinical Performance of Composite Coronal Build -Up in Mutilated Primary Incisors: 3 Years Results
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