Clinical Performance of Composites in Patients With Amelogenesis Imperfecta

Not Applicable

• Conditions: Amelogenesis Imperfecta; Dental Composite; Dental Caries
• Interventions: Other: dental composite

• Registration Number: NCT04897724
• Lead Sponsor: Neslihan Tekçe

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-02
• Primary Completion: 2016-09-19
• Status Verified: 2021-05
• Study First Submitted: 2021-05-18
• Study First Submitted QC: 2021-05-18
• Last Update Submitted: 2021-05-18
• Study First Posted: 2021-05-21
• Last Update Posted: 2021-05-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients have carious lesions in one or more surface of molars and premolars	dental composite	patients received direct composite restorations using a nanohybrid and a nonofil composite restorations

Primary Outcome Measures

Name	Time	Method
Number of failed restorations evaluated according to the modified USPSH criteria in patients with occlusal restorations.	an average of 1 year	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.