Amelogenesis ImperfectaNCT04897724
Clinical Performance of Composites in Patients With Amelogenesis Imperfecta
A study testing dental composite in people with Amelogenesis Imperfecta and Dental Caries, run by Neslihan Tekçe.
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. Read more about this study
- Who is it for?
- Ages 14 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Amelogenesis Imperfecta, Dental Caries, Dental Composite
- What is being tested?
- dental composite
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 2 Sep 2014to 19 Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: The Clinical Performance of Direct Posterior Composite Restorations in Patients With Amelogenesis Imperfecta
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
- Being tested
- dental composite
- Medical subject headings
- Amelogenesis Imperfecta, Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dental compositeOther
clinical performance of composite restorations used for posterior teeth in patients with Amelogenesis Imperfecta
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: dental composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start2 Sep 2014
- Primary completion19 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amelogenesis ImperfectaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neslihan Tekçe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Neslihan Tekçe, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04897724
- Sponsor's protocol ID
- 2014/247
- Status last verified
- May 2021
- First submitted
- 18 May 2021
- Last updated
- 21 May 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Performance of Direct Posterior Composite Restorations in Patients With Amelogenesis Imperfecta
- ClinicalTrials.gov ID
- NCT04897724
- Acronym / sponsor ID
- 2014/247
- Conditions
- Amelogenesis Imperfecta, Dental Caries, Dental Composite
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Neslihan TekçeUniversity, hospital or other
- Study start
- 2 Sep 2014 (actual)
- Primary completion
- 19 Sep 2016 (actual)
- First posted
- 21 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients have carious lesions in one or more surface of molars and premolars | Other | Other: dental compositepatients received direct composite restorations using a nanohybrid and a nonofil composite restorations |
Who may qualify
- Ages
- 14 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dental compositeclinical performance of composite restorations used for posterior teeth in patients with Amelogenesis Imperfecta | Other | patients have carious lesions in one or more surface of molars and premolars |
Primary outcome
Number of failed restorations evaluated according to the modified USPSH criteria in patients with occlusal restorations.
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing dental composite in people with Amelogenesis Imperfecta and Dental Caries, run by Neslihan Tekçe.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 May 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of failed restorations evaluated according to the modified USPSH criteria in patients with occlusal restorations. (time frame: an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2021.