Dent DiseaseMONORTHONCT04459013
Evaluation of the Release of Monomers From Composite Bonding Resins in Orthodontics
An observational study of Dent Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
In recent decades, the field of public health has become increasingly interested in endocrine disruptors, and their effects on humans. Indeed, various scientific studies have highlighted an evolution in the frequency of pathologies due to these substances, affecting in particular the reproductive organs. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Dent Disease
- What is being tested?
- Salivary samples
- How many people
- 41 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jun 2020to 16 Dec 2020
- Phase
- Observational
- 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient of the orthodontic consultation consultant in the dentistry department of the Pitié Salpêtrière hospital,
Who may be able to join
- Patient of the orthodontic consultation consultant in the dentistry department of the Pitié Salpêtrière hospital,
- Information and collection of the non-opposition of the adult patient or representatives of the parental authority for minors
- Good dental hygiene at the discretion of the investigator
- Patient agreeing to be followed for 6 months
- Good written and oral comprehension of the French language
- case-specific:
Show all 11Show fewer
- Age between 10 and 70 years inclusive,
- Patients undergoing orthodontic treatment (multi-attachment device) with planned debagging and requiring compression with bonded mandibular wire from canine to canine, and maxillary groove
- Specific to witnesses:
- Age between 18 and 70 inclusive
- Patients undergoing orthodontic treatment (multi-attachment appliance) with planned debridement without the need for a retainer
Who cannot join
- Under tutorship or curatorship
- Opposition of the minor patient
- Gingival inflammation
- Patients requiring maxillary bonded restraint
- Composite restoration in the mouth
- Carious lesions
Show all 9Show fewer
- Smokers
- Patients with chronic pathologies and / or under medication
- Chronic exposure to Bisphenol A.
Trial locations and contacts
1 site in 1 country.
France1 site
Service Odontology, Hôpital Pitié-Salpêtrière
Paris, Île-de-France Region, 75013
About this study
In recent decades, the field of public health has become increasingly interested in endocrine disruptors, and their effects on humans. Indeed, various scientific studies have highlighted an evolution in the frequency of pathologies due to these substances, affecting in particular the reproductive organs. Many concerns are expressed about the impact of these substances, present in the environment or in consumer products, on the hormonal system. Effects have been observed in animals in experimental studies, but the question of extrapolating these results to humans arises, especially for exposures at low doses.
In orthodontics, the composite is the material of choice mainly for bonding fasteners, then bonding a compression wire. These composite materials contain many monomers. The polemics launched on Bisphenol A and the questions of our patients on the nature and toxicity of dental products oblige us to reflect on their harmfulness after their placement in the oral cavity. Many questions arise today about dental composites and their participation in the release of endocrine disruptors. Indeed, Bisphenol A is used in the manufacturing process of the monomers of orthodontic composites, as precursors of Bis-GMA and Bis-DMA. The objective of this study is to search for the presence of BPA, TEGDMA, BisGMA, BisDMA and UDMA monomers, and to carry out the samples and their analysis at different clinical times (at T0, after the removal of orthodontic attachments, after the placement of the compression, one hour later, one week later, one month later and 6 months later) and the comparison of this quantification to that without orthodontic restraint. Studies have been performed in vitro, but very little in vivo. In addition, these studies are only carried out on release at the time of installation, but few are interested in the continuation of the phenomenon over time and the deterioration of the composite. Although the short-term toxicity of BPA is low, its dangerousness lies in its potential endocrine disrupting effect and which can induce long-term chronic toxicity.
Compounds such as TEGDMA, BisGMA, BisDMA and UDMA differ greatly in their volatility due to their different chemical structures as well as in their stability in saliva; Many methods have been developed to study each monomer individually or to study them simultaneously using different analytical techniques to determine their presence and to quantify them after their release from dental products. The analysis of the samples is carried out by liquid chromatography (HPLC).
Read the detailed description
For several years, we have been wondering about the potential deleterious effects of bisphenol A (BPA) on our organism. Known as an endocrine disruptor, its action has been demonstrated at different levels of the human body and by different mechanisms. Its endocrine activity is due to its structure close to that of estradiol. Cytotoxicity is the property of a chemical or biological agent to be toxic to cells, possibly destroying it. Bisphenol A (BPA) has received increasing attention in recent years. It is used in the monomer manufacturing process of composites customary in orthodontics, as a precursor of Bis-DMA and Bis-GMA, but is not normally found in pure form in these composites. In the mouth, these materials are subject to numerous degradation constraints, initial and long-term: thermal variations, pH change, mechanical wear, enzymatic, bacterial and salivary attack. They are therefore responsible for the possible release of BPA, found in many human biological fluids, including saliva. The monomers present in the composite resins are released in 2 stages: immediate release where the non-polymerized monomers are found in the saliva for a few hours after the treatment, delayed release where the monomers can be released following the treatment by the various mechanisms of wear and degradation of the composite. If the BPA is mainly released in saliva within three hours after the establishment of the dental restoration, the long-term release remains to be determined, which explains the patient's follow-up time of 6 months.
The main objective of this research is the quantification of the Bisphenol A monomer released during the placement of a mandibular orthodontic compression in order to raise awareness among professionals and the comparison of this quantification to that without orthodontic restraint. The study relates to the analysis of patients followed in the dental department at the Pitié Salpetrière hospital. The study briefing note will be presented to patients during the visit. Non-opposition will be collected and notified in the patient's medical file after a 15-day cooling-off period.
The salivary samples will be collected at 5 defined times: before removal of the orthodontic brackets (T0), after removal (T1), just after application of the compression (T2), then at one hour (T3), one month (T4) and 6 months (T5), as part of the end of their orthodontic treatment. Control samples will be taken from patients who do not have a composite restoration in their mouth. The inclusion criteria are patients undergoing orthodontic treatment (multi-attachment device) with planned debagging and requiring compression with mandibular bonded wire from canine to canine and maxillary groove, without composite restoration in the mouth, with good hygiene and not gingival inflammation. The exclusion criteria are patients requiring maxillary bonded compression, with composite restoration in the mouth, carious lesions, smokers, with chronic pathologies and / or drugs, with chronic exposure to Bisphenol A (construction sites, service stations ... ). The composite cartridges will be weighed before and after their use, to have the exact quantity of material placed in the mouth. For laying the compression wire, the protocol will also be identical to the bonding protocol in adhesive dentistry.
The samples are analyzed by liquid chromatography (HPLC) on the Bioprofiler platform (Metabolism Platform) of the Functional and Adaptive Biology Unit - CNRS UMR 8251 at Paris Diderot University.
The analytical method chosen for the identification and quantification of the compounds is high pressure liquid chromatography (HPLC). This method allows the separation of the constituents of a very complex mixture. The HPLC consists of two pumps which maintain a mobile phase under pressure in a column (stationary phase). The sample is injected into the circulation system of the mobile phase and passes into the column where the different constituents are more or less retained. The nature of the mobile phase and of the column allows separation according to the physicochemical properties of the constituents of a mixture.
Developments and optimizations of extraction and dosage methods allowing the analysis of the release of bisphenols by orthodontic materials in saliva samples were carried out on this platform.
- Conditions
- Dent Disease
- Being tested
- Salivary samples
- Keywords
- Bisphenol A, toxicity, Composite, orthodontic retainers, release, endocrine disruptors
- Medical subject headings
- Dent Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salivary samplesOther
The salivary samples will be collected at 5 defined times
| Study group | Role | What they receive |
|---|---|---|
| Patient of the orthodontic consultation | Not described Receives: Other: Salivary samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changement of quantity of the Bisphenol A
The main objective of this research is the quantification of the Bisphenol A monomer released during the placement of a mandibular orthodontic compression in order to raise awareness among professionals or without orthodontic restraint..
Measured: before any medical procedure, and regularly after the medical procedure
Secondary outcomes (2)
Changement of quantity of the release of TEGDMA monomers; UDMA; BisGMA and BisDMA
The secondary objective of this study is the quantification of the release of TEGDMA monomers; UDMA; BisGMA and BisDMA by orthodontic materials in saliva samples.
Measured: before any medical procedure, and regularly after the medical procedure
Changement of those quantities in patients with mandibular orthodontic restraints with patients without restraints
- High pressure liquid chromatography (HPLC) quantification in "controls" of bisphenol A monomer released in saliva samples, TEGDMA, UDMA, BisGMA and BisDMA monomers
Measured: before any medical procedure, and regularly after the medical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start3 Jun 2020
- Primary completion30 Oct 2020
- Study completion16 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dent DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
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
- NCT04459013
- Sponsor's protocol ID
- APHP200328
- Acronym
- MONORTHO
- Status last verified
- Nov 2023
- First submitted
- 17 Jun 2020
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Release of Monomers From Composite Bonding Resins in Orthodontics
- ClinicalTrials.gov ID
- NCT04459013
- Acronym / sponsor ID
- MONORTHO / APHP200328
- Conditions
- Dent Disease
- Keywords
- Bisphenol A, toxicity, Composite, orthodontic retainers, release, endocrine disruptors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 3 Jun 2020 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 16 Dec 2020 (actual)
- First posted
- 7 Jul 2020 (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 recent decades, the field of public health has become increasingly interested in endocrine disruptors, and their effects on humans. Indeed, various scientific studies have highlighted an evolution in the frequency of pathologies due to these substances, affecting in particular the reproductive organs. Many concerns are expressed about the impact of these substances, present in the environment or in consumer products, on the hormonal system. Effects have been observed in animals in experimental studies, but the question of extrapolating these results to humans arises, especially for exposures at low doses.
In orthodontics, the composite is the material of choice mainly for bonding fasteners, then bonding a compression wire. These composite materials contain many monomers. The polemics launched on Bisphenol A and the questions of our patients on the nature and toxicity of dental products oblige us to reflect on their harmfulness after their placement in the oral cavity. Many questions arise today about dental composites and their participation in the release of endocrine disruptors. Indeed, Bisphenol A is used in the manufacturing process of the monomers of orthodontic composites, as precursors of Bis-GMA and Bis-DMA. The objective of this study is to search for the presence of BPA, TEGDMA, BisGMA, BisDMA and UDMA monomers, and to carry out the samples and their analysis at different clinical times (at T0, after the removal of orthodontic attachments, after the placement of the compression, one hour later, one week later, one month later and 6 months later) and the comparison of this quantification to that without orthodontic restraint. Studies have been performed in vitro, but very little in vivo. In addition, these studies are only carried out on release at the time of installation, but few are interested in the continuation of the phenomenon over time and the deterioration of the composite. Although the short-term toxicity of BPA is low, its dangerousness lies in its potential endocrine disrupting effect and which can induce long-term chronic toxicity.
Compounds such as TEGDMA, BisGMA, BisDMA and UDMA differ greatly in their volatility due to their different chemical structures as well as in their stability in saliva; Many methods have been developed to study each monomer individually or to study them simultaneously using different analytical techniques to determine their presence and to quantify them after their release from dental products. The analysis of the samples is carried out by liquid chromatography (HPLC).
Detailed description
For several years, we have been wondering about the potential deleterious effects of bisphenol A (BPA) on our organism. Known as an endocrine disruptor, its action has been demonstrated at different levels of the human body and by different mechanisms. Its endocrine activity is due to its structure close to that of estradiol. Cytotoxicity is the property of a chemical or biological agent to be toxic to cells, possibly destroying it. Bisphenol A (BPA) has received increasing attention in recent years. It is used in the monomer manufacturing process of composites customary in orthodontics, as a precursor of Bis-DMA and Bis-GMA, but is not normally found in pure form in these composites. In the mouth, these materials are subject to numerous degradation constraints, initial and long-term: thermal variations, pH change, mechanical wear, enzymatic, bacterial and salivary attack. They are therefore responsible for the possible release of BPA, found in many human biological fluids, including saliva. The monomers present in the composite resins are released in 2 stages: immediate release where the non-polymerized monomers are found in the saliva for a few hours after the treatment, delayed release where the monomers can be released following the treatment by the various mechanisms of wear and degradation of the composite. If the BPA is mainly released in saliva within three hours after the establishment of the dental restoration, the long-term release remains to be determined, which explains the patient's follow-up time of 6 months.
The main objective of this research is the quantification of the Bisphenol A monomer released during the placement of a mandibular orthodontic compression in order to raise awareness among professionals and the comparison of this quantification to that without orthodontic restraint. The study relates to the analysis of patients followed in the dental department at the Pitié Salpetrière hospital. The study briefing note will be presented to patients during the visit. Non-opposition will be collected and notified in the patient's medical file after a 15-day cooling-off period.
The salivary samples will be collected at 5 defined times: before removal of the orthodontic brackets (T0), after removal (T1), just after application of the compression (T2), then at one hour (T3), one month (T4) and 6 months (T5), as part of the end of their orthodontic treatment. Control samples will be taken from patients who do not have a composite restoration in their mouth. The inclusion criteria are patients undergoing orthodontic treatment (multi-attachment device) with planned debagging and requiring compression with mandibular bonded wire from canine to canine and maxillary groove, without composite restoration in the mouth, with good hygiene and not gingival inflammation. The exclusion criteria are patients requiring maxillary bonded compression, with composite restoration in the mouth, carious lesions, smokers, with chronic pathologies and / or drugs, with chronic exposure to Bisphenol A (construction sites, service stations ... ). The composite cartridges will be weighed before and after their use, to have the exact quantity of material placed in the mouth. For laying the compression wire, the protocol will also be identical to the bonding protocol in adhesive dentistry.
The samples are analyzed by liquid chromatography (HPLC) on the Bioprofiler platform (Metabolism Platform) of the Functional and Adaptive Biology Unit - CNRS UMR 8251 at Paris Diderot University.
The analytical method chosen for the identification and quantification of the compounds is high pressure liquid chromatography (HPLC). This method allows the separation of the constituents of a very complex mixture. The HPLC consists of two pumps which maintain a mobile phase under pressure in a column (stationary phase). The sample is injected into the circulation system of the mobile phase and passes into the column where the different constituents are more or less retained. The nature of the mobile phase and of the column allows separation according to the physicochemical properties of the constituents of a mixture.
Developments and optimizations of extraction and dosage methods allowing the analysis of the release of bisphenols by orthodontic materials in saliva samples were carried out on this platform.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient of the orthodontic consultation | – | Other: Salivary samples |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient of the orthodontic consultation consultant in the dentistry department of the Pitié Salpêtrière hospital,
Key inclusion criteria (11 listed)
- Patient of the orthodontic consultation consultant in the dentistry department of the Pitié Salpêtrière hospital,
- Information and collection of the non-opposition of the adult patient or representatives of the parental authority for minors
- Good dental hygiene at the discretion of the investigator
- Patient agreeing to be followed for 6 months
- Good written and oral comprehension of the French language
Key exclusion criteria (9 listed)
- Under tutorship or curatorship
- Opposition of the minor patient
- Gingival inflammation
- Patients requiring maxillary bonded restraint
- Composite restoration in the mouth
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 |
|---|---|---|
| Salivary samplesThe salivary samples will be collected at 5 defined times | Other | Patient of the orthodontic consultation |
Primary outcome
Changement of quantity of the Bisphenol A
Time frame: before any medical procedure, and regularly after the medical procedure
The main objective of this research is the quantification of the Bisphenol A monomer released during the placement of a mandibular orthodontic compression in order to raise awareness among professionals or without orthodontic restraint..
2 secondary outcomes
Changement of quantity of the release of TEGDMA monomers; UDMA; BisGMA and BisDMA
Time frame: before any medical procedure, and regularly after the medical procedure
Changement of those quantities in patients with mandibular orthodontic restraints with patients without restraints
Time frame: before any medical procedure, and regularly after the medical procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Dent Disease
Active, not recruitingObservational study
Ultrasound for Socket Healing Evaluation
Healing Wound, Alveolar; Wound
RecruitingObservational study
Prospective Research Rare Kidney Stones (ProRKS)
Hyperoxaluria, Cystinuria
RecruitingObservational study
Rare Kidney Stone Consortium Biobank
Primary Hyperoxaluria, Dent Disease
RecruitingObservational study
Rare Kidney Stone Consortium Patient Registry
Primary Hyperoxaluria, Dent Disease
Recruiting
PMCF Study on The Performance and Safety of ON DENT® PMMA Discs/Blocks and Resin Products for Temporary Restorations
Tooth Loss, Dentin Caries
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.
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 Dent Disease, 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 11 inclusion and 9 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: finished, as of the sponsor's last update on 21 Nov 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changement of quantity of the Bisphenol A (time frame: before any medical procedure, and regularly after the medical procedure). 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 Nov 2023.