Amelogenesis ImperfectaCOLOEMAILNCT04704089
Colorimetric, Ultra-structural and Elemental Comparison of Dental Enamel Defects
An observational study of Amelogenesis Imperfecta and Dental Fluoroses, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The study focuses on the analysis of enamel defects grouping together hypomineralization and hypoplasia. It focuses on 3 very characteristic enamel pathologies that are most often encountered in dental consultations: Molar Incisor Hypomineralization (MIH), dental fluorosis (FD) and amelogenesis imperfecta (AI). Read more about this study
- Who is it for?
- Ages 8 to 55 years
- Conditions the study is for
- Amelogenesis Imperfecta, Dental Fluoroses, Hypomineralization Molar Incisor
- What is being tested?
- spectrophotometer and Biological (protein analysis by western blot or mass spectrometry of matrix proteins), structural (electron microscopy) and physico-chemical analyses
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jul 2022to 18 Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 8 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Major or minor patients with Hereditary Imperfect Amelogenesis Imperfecta (HIA), Dental Fluorosis (DF), Incisor and Molar Hypomineralization (MIH) or Control
Who may be able to join
- Age between 8 and 55 years old
- Carrier of one of the following 3 quantitative pre-eruptive enamel anomalies : AIH, dental fluorosis or MIH
- Information and collection of the non-opposition of the adult patient or of the representative(s) of parental authority present for the minors.
- Criteria for non-inclusion :
- Pregnant or breastfeeding woman
- Under guardianship or curators
Show all 22Show fewer
- Opposition of the minor patient
- Presenting pre-eruptive anomalies only on the molars (the spectrophotometer can only take pictures of the anterior dental sector (incisors and canines)).
- Other types of hypomineralization (post-eruptive, of traumatic or infectious origin, idiopathic).
- Having undergone radiotherapy or chemotherapy inducing dental and periodontal damage.
- Having systemic abnormalities (unbalanced diseases), haemochromatosis, porphyria
- Under medication likely to disturb the coloring of the teeth
- For witnesses :
- Age between 8 and 55 years old
- Information and collection of the non-opposition of the adult witness or of the representative(s) of parental authority present for the minors.
- Free of any anomaly of tooth structure, exogenous dyschromia and carious lesions.
- Criteria for non-inclusion :
- Pregnant or breastfeeding woman
- Under guardianship or curators
- Opposition of the minor witness
- Carrier of a quantitative pre-eruptive enamel anomaly
- Polycarpus (preventing the diagnosis of amyl hypomineralization)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service d'odontologie, Hôpital Pitié-Salpêtrière
Paris, 75013
Sophia HOUARI, MCU-PH, 06 12 16 88 35, sophia.houari@aphp.fr
About this study
Official title: Colorimetric Comparison of Email Defects Using Spectrophotometric and Computer Techniques and Biological, Structural and Physico-chemical Analyses of Teeth or Pathological Enamel
The study focuses on the analysis of enamel defects grouping together hypomineralization and hypoplasia. It focuses on 3 very characteristic enamel pathologies that are most often encountered in dental consultations: Molar Incisor Hypomineralization (MIH), dental fluorosis (FD) and amelogenesis imperfecta (AI). The research focuses on the use of a spectrophotometer for measuring tooth colors: the Zfx SpectroShade® (MHT) and its software as a means of early diagnosis of pre-eruptive enamel abnormalities. The main objective of the study is to analyze the color parameters of teeth affected with one of the 3 enamel abnormalities for use of the spectrophotometer as a non-invasive diagnostic tool for enamel defects.
The secondary objective is focused on the biological, structural and physicochemical characterizations of these different enamel pathologies from extracted teeth or enamel biopsies that must be ground to achieve a restoration.
Read the detailed description
Methodology:
V1 inclusion visit (D1):
The subjects will be screened during a consultation carried out as part of the treatment in the participating dentistry departments. The inclusion and non-inclusion criteria for participants will be verified and the study will be offered to eligible patients and controls. The research briefing note will be given and the non-objection of the participants (adults and representative (s) of parental authority) will be collected. The investigator will then take the photographs and spectrophotometer shots (at least 2 teeth per participant).
V2 follow-up visit (within 2 months of the inclusion visit (D2 to M2)):
The patients will be reviewed in consultation as part of the treatment for selective grinding for dental restoration or extraction (if the tooth (s) is (are) no longer storable). The teeth or pathological enamel samples will be recovered and centralized at the Laboratory of Oral Molecular Physiopathology.
Biological, structural and physico-chemical analyzes will be carried out from these samples.
In order to ensure follow-up of participants, the principal investigator of each center will maintain a correspondence table including the participant's identity and his research identification number. He will also keep a register of oppositions up to date.
The subject's opposition or participation will be notified in his medical file. A copy of the briefing notes and non-objection forms signed by the dentist will be kept on site with the research documents. Minors who become adults during their participation will benefit from appropriate information and their non-objection will be collected.
Primary endpoint Analysis, using the spectrophotometer, of the numerical values of the color of the teeth in each of the populations studied (Hereditary amelogenesis imperfecta (AIH), dental fluorosis (FD), Hypomineralization Incisors and Molar (MIH) and control).
For each pathology, the values of these parameters will be compared. Secondary endpoints
- Intra-pathology classification according to the severity of each pathology.
- Characterization and biological, structural and physicochemical analysis of these different pathologies from extracted teeth or enamel biopsy to be ground to achieve a restoration.
Sample analysis The teeth samples will be stored at room temperature in the Oral Molecular Physiopathology laboratory in the Research Center.
During the research, biological, structural and physicochemical analyzes will be carried out at the laboratory or in another laboratory in France or abroad. A contract will be established upstream of these analyzes with the partner laboratory.
At the end of the research, samples not destroyed by destructive analysis techniques will be embedded in the resin and stored for 10 years before being destroyed. These samples can be used for additional analyzes (biological, structural and physico-chemical) according to the request of the references for the publication process.
- Being tested
- spectrophotometer, Biological (protein analysis by western blot or mass spectrometry of matrix proteins), structural (electron microscopy) and physico-chemical analyses
- Keywords
- Colorimetry (MeSH), Amelogenesis Imperfecta (MeSH), Dental Fluorosis (MeSH), Molar-incisor-Hypomineralization (MeSH), Developmental Enamel Defects (MeSH), Shade selection, Dental color matching, Diagnosis (MeSH)
- Medical subject headings
- Amelogenesis Imperfecta, Fluorosis, Dental, Molar Hypomineralization, Developmental Defects of Enamel, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spectrophotometerOther
- Calibration of the spectrophotometer (calibration of white and green color on the provided support),
- Placing the patient or witness in the chair,
- Placement of intraoral retractors,
- Photographs of the dental arch in occlusion as well as slightly open mouth to visualize the mandibular incisors,
- If MIH is suspected, occlusal images of the occlusal surfaces of the first molars will be taken with the help of a dental mirror,
- Shooting with the spectrophotometer centered on each of the teeth of interest in the anterior sector with verification of the good quality of the shot according to the axis (validated in green on the camera),
- Backup of images with coded identification number
Biological (protein analysis by western blot or mass spectrometry of matrix proteins), structural (electron microscopy) and physico-chemical analysesOther
- Chemical analysis of enamel mineral.
- Techniques of spectrometry and spectroscopy (Raman and FTIR)
- Atomic Probe Tomography and Protein Mass Spectrometry (ICP-MS).
| Study group | Role | What they receive |
|---|---|---|
| spectrophotometer, and numerical values of tooth color in the populations studied | at the first visit Shooting with Spectrophotometer and at the second visit for all patients except control population: Tooth extraction or restorative treatment Collection of teeth or enamel debris for analysis Receives: Other: spectrophotometer; Other: Biological (protein analysis by western blot or mass spectrometry of matrix proteins), structural (electron microscopy) and physico-chemical analyses |
What is being measured
The primary outcome is the main question the study is designed to answer.
analyze the color parameters of teeth presenting one of the 3 enamel anomalies in order to use the spectrophotometer as a non-invasive diagnostic tool for enamel dyschromia.
Measured: at the first visit = inclusion visit
Secondary outcomes (4)
Biological characterization of the proteins of the dental enamel matrix by Western Blot and/or mass spectrometry from samples (extracted teeth or enamel biopsies to be ground during the treatment).
Measured: at the second visit, 2 months after inclusion visit and after tooth extraction
Ultra-structural characterization under electron microscope and biomechanics by nanoindentation of enamel pathologies from extracted teeth or enamel biopsies to be ground during the treatment.
Measured: at the second visit, 2 months after inclusion visit and after tooth extraction
Physico-chemical characterization by different spectroscopic techniques of enamel pathologies from extracted teeth or enamel biopsies to be ground during the treatment.
Measured: at the second visit, 2 months after inclusion visit and after tooth extraction
Physico-chemical characterization by atomic probe tomography of enamel pathologies from extracted teeth or enamel biopsies to be ground during the treatment.
Measured: at the second visit, 2 months after inclusion visit and after tooth extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start18 Jul 2022
- Primary completion18 Apr 2026 (estimated)
- Study completion18 Apr 2026 (estimated)
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.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04704089
- Sponsor's protocol ID
- APHP190001
- Acronym
- COLOEMAIL
- Status last verified
- Jun 2025
- First submitted
- 18 Dec 2020
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colorimetric Comparison of Email Defects Using Spectrophotometric and Computer Techniques and Biological, Structural and Physico-chemical Analyses of Teeth or Pathological Enamel
- ClinicalTrials.gov ID
- NCT04704089
- Acronym / sponsor ID
- COLOEMAIL / APHP190001
- Keywords
- Colorimetry (MeSH), Amelogenesis Imperfecta (MeSH), Dental Fluorosis (MeSH), Molar-incisor-Hypomineralization (MeSH), Developmental Enamel Defects (MeSH), Shade selection, Dental color matching, Diagnosis (MeSH)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 18 Jul 2022 (actual)
- Primary completion
- 18 Apr 2026 (estimated)
- Study completion
- 18 Apr 2026 (estimated)
- First posted
- 11 Jan 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.
The study focuses on the analysis of enamel defects grouping together hypomineralization and hypoplasia. It focuses on 3 very characteristic enamel pathologies that are most often encountered in dental consultations: Molar Incisor Hypomineralization (MIH), dental fluorosis (FD) and amelogenesis imperfecta (AI). The research focuses on the use of a spectrophotometer for measuring tooth colors: the Zfx SpectroShade® (MHT) and its software as a means of early diagnosis of pre-eruptive enamel abnormalities. The main objective of the study is to analyze the color parameters of teeth affected with one of the 3 enamel abnormalities for use of the spectrophotometer as a non-invasive diagnostic tool for enamel defects.
The secondary objective is focused on the biological, structural and physicochemical characterizations of these different enamel pathologies from extracted teeth or enamel biopsies that must be ground to achieve a restoration.
Detailed description
Methodology:
V1 inclusion visit (D1):
The subjects will be screened during a consultation carried out as part of the treatment in the participating dentistry departments. The inclusion and non-inclusion criteria for participants will be verified and the study will be offered to eligible patients and controls. The research briefing note will be given and the non-objection of the participants (adults and representative (s) of parental authority) will be collected. The investigator will then take the photographs and spectrophotometer shots (at least 2 teeth per participant).
V2 follow-up visit (within 2 months of the inclusion visit (D2 to M2)):
The patients will be reviewed in consultation as part of the treatment for selective grinding for dental restoration or extraction (if the tooth (s) is (are) no longer storable). The teeth or pathological enamel samples will be recovered and centralized at the Laboratory of Oral Molecular Physiopathology.
Biological, structural and physico-chemical analyzes will be carried out from these samples.
In order to ensure follow-up of participants, the principal investigator of each center will maintain a correspondence table including the participant's identity and his research identification number. He will also keep a register of oppositions up to date.
The subject's opposition or participation will be notified in his medical file. A copy of the briefing notes and non-objection forms signed by the dentist will be kept on site with the research documents. Minors who become adults during their participation will benefit from appropriate information and their non-objection will be collected.
Primary endpoint Analysis, using the spectrophotometer, of the numerical values of the color of the teeth in each of the populations studied (Hereditary amelogenesis imperfecta (AIH), dental fluorosis (FD), Hypomineralization Incisors and Molar (MIH) and control).
For each pathology, the values of these parameters will be compared. Secondary endpoints
- Intra-pathology classification according to the severity of each pathology.
- Characterization and biological, structural and physicochemical analysis of these different pathologies from extracted teeth or enamel biopsy to be ground to achieve a restoration.
Sample analysis The teeth samples will be stored at room temperature in the Oral Molecular Physiopathology laboratory in the Research Center.
During the research, biological, structural and physicochemical analyzes will be carried out at the laboratory or in another laboratory in France or abroad. A contract will be established upstream of these analyzes with the partner laboratory.
At the end of the research, samples not destroyed by destructive analysis techniques will be embedded in the resin and stored for 10 years before being destroyed. These samples can be used for additional analyzes (biological, structural and physico-chemical) according to the request of the references for the publication process.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| spectrophotometer, and numerical values of tooth color in the populations studied | – | Other: spectrophotometer, Other: Biological (protein analysis by western blot or mass spectrometry of matrix proteins), structural (electron microscopy) and physico-chemical analysesat the first visit Shooting with Spectrophotometer and at the second visit for all patients except control population: Tooth extraction or restorative treatment Collection of teeth or enamel debris for analysis |
Who may qualify
- Ages
- 8 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Major or minor patients with Hereditary Imperfect Amelogenesis Imperfecta (HIA), Dental Fluorosis (DF), Incisor and Molar Hypomineralization (MIH) or Control
Key inclusion criteria (22 listed)
- Age between 8 and 55 years old
- Carrier of one of the following 3 quantitative pre-eruptive enamel anomalies : AIH, dental fluorosis or MIH
- Information and collection of the non-opposition of the adult patient or of the representative(s) of parental authority present for the minors.
- Pregnant or breastfeeding woman
- Under guardianship or curators
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| spectrophotometer* Calibration of the spectrophotometer (calibration of white and green color on the provided support), * Placing the patient or witness in the chair, * Placement of intraoral retractors, * Photographs of the dental arch in occlusion as well as slightly open mouth to visualize the mandibular incisors, * If MIH is suspected, occlusal images of the occlusal surfaces of the first molars will be taken with the help of a dental mirror, * Shooting with the spectrophotometer centered on each of the teeth of interest in the anterior sector with verification of the good quality of the shot according to the axis (validated in green on the camera), * Backup of images with coded identification number | Other | spectrophotometer, and numerical values of tooth color in the populations studied |
| Biological (protein analysis by western blot or mass spectrometry of matrix proteins), structural (electron microscopy) and physico-chemical analyses* Chemical analysis of enamel mineral. * Techniques of spectrometry and spectroscopy (Raman and FTIR) * Atomic Probe Tomography and Protein Mass Spectrometry (ICP-MS). | Other | spectrophotometer, and numerical values of tooth color in the populations studied |
Primary outcome
analyze the color parameters of teeth presenting one of the 3 enamel anomalies in order to use the spectrophotometer as a non-invasive diagnostic tool for enamel dyschromia.
Time frame: at the first visit = inclusion visit
4 secondary outcomes
Biological characterization of the proteins of the dental enamel matrix by Western Blot and/or mass spectrometry from samples (extracted teeth or enamel biopsies to be ground during the treatment).
Time frame: at the second visit, 2 months after inclusion visit and after tooth extraction
Ultra-structural characterization under electron microscope and biomechanics by nanoindentation of enamel pathologies from extracted teeth or enamel biopsies to be ground during the treatment.
Time frame: at the second visit, 2 months after inclusion visit and after tooth extraction
Physico-chemical characterization by different spectroscopic techniques of enamel pathologies from extracted teeth or enamel biopsies to be ground during the treatment.
Time frame: at the second visit, 2 months after inclusion visit and after tooth extraction
Physico-chemical characterization by atomic probe tomography of enamel pathologies from extracted teeth or enamel biopsies to be ground during the treatment.
Time frame: at the second visit, 2 months after inclusion visit and after tooth extraction
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amelogenesis Imperfecta and Dental Fluoroses, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 22 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sophia HOUARI, MCU-PH (06 12 16 88 35, sophia.houari@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
analyze the color parameters of teeth presenting one of the 3 enamel anomalies in order to use the spectrophotometer as a non-invasive diagnostic tool for enamel dyschromia. (time frame: at the first visit = inclusion visit). 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 3 Jul 2025.