Back to resultsClinical Performance of Composites in Patients With Amelogenesis Imperfecta
Primary Purpose
Amelogenesis Imperfecta, Dental Caries, Dental Composite
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
dental composite
Sponsored by
About this trial
This is an interventional treatment trial for Amelogenesis Imperfecta
Eligibility Criteria
Inclusion Criteria:
- the patient had to require treatment due to carious lesions in one or more surface of molars and premolars,
- AI diagnosis had to be made, which had to be verified clinically, and also confirmed by anamnestic family history, or clinical examination concerning Witkop's classification
Exclusion Criteria:
- patients with developmental enamel defects of other origins such as fluorosis, molar incisor hypomineralization;
- AI was associated with other oral developmental or systemic disorders, and dental abnormalities such as open-bite, deep-bite, and cross-bite;
- patients who were unable to provide their informed consent.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
patients have carious lesions in one or more surface of molars and premolars
Arm Description
patients received direct composite restorations using a nanohybrid and a nonofil composite restorations
Outcomes
Primary Outcome Measures
Number of failed restorations evaluated according to the modified USPSH criteria in patients with occlusal restorations.
In restorations, retention rate, color match, wear or loss of anatomic form, marginal discoloration, caries, marginal adaptation, and surface texture were scored success or failure according to modified United States Public Health Service (USPHS) criteria. According to this criteria, success restorations received Alfa (A) or Bravo (B) scores. Alfa (A) represents the ideal clinical situation; Bravo (B) is the clinically acceptable. Failed restorations received Charlie (C) or Delta (D) scores. Charlie (C) is the clinically unacceptable situations where the restorations had to be replaced; Delta (D) is the situation where the restoration is fractured, mobile or missing and needed to be replaced immediately.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04897724
Brief Title
Clinical Performance of Composites in Patients With Amelogenesis Imperfecta
Official Title
The Clinical Performance of Direct Posterior Composite Restorations in Patients With Amelogenesis Imperfecta
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 2, 2014 (Actual)
Primary Completion Date
September 19, 2016 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Neslihan Tekçe
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
In AI patients, adhesion still remains the first option in order to achieve an early, minimally invasive intervention, and the altered enamel still represents an acceptable substrate for bonding in some AI variants. Many cases have revealed that the direct composite restorations provide satisfactory esthetic and functionality in restoring AI-affected teeth. The objective of this study was to evaluate the clinical performance of composite restorations in posterior teeth in patients afflicted with Amelogenesis Imperfecta using nanohybrid and nanofill composite materials
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amelogenesis Imperfecta, Dental Caries, Dental Composite
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patients have carious lesions in one or more surface of molars and premolars
Arm Type
Other
Arm Description
patients received direct composite restorations using a nanohybrid and a nonofil composite restorations
Intervention Type
Other
Intervention Name(s)
dental composite
Intervention Description
clinical performance of composite restorations used for posterior teeth in patients with Amelogenesis Imperfecta
Primary Outcome Measure Information:
Title
Number of failed restorations evaluated according to the modified USPSH criteria in patients with occlusal restorations.
Description
In restorations, retention rate, color match, wear or loss of anatomic form, marginal discoloration, caries, marginal adaptation, and surface texture were scored success or failure according to modified United States Public Health Service (USPHS) criteria. According to this criteria, success restorations received Alfa (A) or Bravo (B) scores. Alfa (A) represents the ideal clinical situation; Bravo (B) is the clinically acceptable. Failed restorations received Charlie (C) or Delta (D) scores. Charlie (C) is the clinically unacceptable situations where the restorations had to be replaced; Delta (D) is the situation where the restoration is fractured, mobile or missing and needed to be replaced immediately.
Time Frame
an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
the patient had to require treatment due to carious lesions in one or more surface of molars and premolars,
AI diagnosis had to be made, which had to be verified clinically, and also confirmed by anamnestic family history, or clinical examination concerning Witkop's classification
Exclusion Criteria:
patients with developmental enamel defects of other origins such as fluorosis, molar incisor hypomineralization;
AI was associated with other oral developmental or systemic disorders, and dental abnormalities such as open-bite, deep-bite, and cross-bite;
patients who were unable to provide their informed consent.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Clinical Performance of Composites in Patients With Amelogenesis Imperfecta
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