Clinical Performance of Composites in Patients With Amelogenesis Imperfecta

NCT04897724 | Unknown

• 1 other identifier: 2014/247
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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

Conditions

Amelogenesis Imperfecta; Dental Caries; Dental Composite

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

patients have carious lesions in one or more surface of molars and premolars

OTHER

patients received direct composite restorations using a nanohybrid and a nonofil composite restorations

Other: dental composite

Interventions

dental composite OTHER

clinical performance of composite restorations used for posterior teeth in patients with Amelogenesis Imperfecta

patients have carious lesions in one or more surface of molars and premolars

Eligibility Criteria

• Age: 14 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neslihan Tekçe: lead

MeSH Terms

Conditions

Amelogenesis Imperfecta; Dental Caries

Condition Hierarchy (Ancestors)

Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Tooth Demineralization

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: May 21, 2021
• Study Start: September 2, 2014
• Primary Completion: September 19, 2016
• Last Updated: May 21, 2021

Record last verified: 2021-05