Clinical Performance of Composites in Patients With Amelogenesis Imperfecta

Dental Caries Clinical Trial

Official title:

The Clinical Performance of Direct Posterior Composite Restorations in Patients With Amelogenesis Imperfecta

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04897724
• Other study ID #: 2014/247
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 2, 2014

Study information

• Verified date: May 2021
• Source: Kocaeli University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. primary completion date: September 19, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Amelogenesis Imperfecta
• Dental Caries
• Dental Composite

Intervention

Other:
• dental composite
clinical performance of composite restorations used for posterior teeth in patients with Amelogenesis Imperfecta

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Neslihan Tekçe

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	an average of 1 year