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Status unknownNCT04897724Updated May 21, 2021

Clinical Performance of Composites in Patients With Amelogenesis Imperfecta

An interventional study of dental composite in Amelogenesis Imperfecta, Dental Caries and Dental Composite, sponsored by Neslihan Tekçe. Status unknown. Open to participants aged 14 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-21.

Sponsored by Neslihan Tekçe · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2021), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
14 Years to 30 Years
Sex
All
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Study 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

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Conditions studied

  • Amelogenesis Imperfecta
  • Dental Caries
  • Dental Composite

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Who can participate

Ages eligible
14 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Enrollment
15 participants (actual)

Study arms

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

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

    Other: dental composite

Interventions

  • Otherdental composite

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

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What researchers measure

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.

    Time frame: an average of 1 year

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT04897724
Lead sponsor
Neslihan Tekçe
Responsible party
Neslihan Tekçe (Associate Professor, Kocaeli University) — Sponsor-investigator
First posted
May 21, 2021
Start date
Sep 2, 2014
Primary completion
Sep 19, 2016
Last update
May 21, 2021

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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