Proximal CariesNCT02191943
Lesion Progression of Approximal Caries After Resin Infiltration
A study testing Duraphat and Icon approximal caries infiltration kit in people with Proximal Caries, run by DMG Dental Material Gesellschaft mbH at 1 site in United States.
Trial summary
The aim of the planned in-vivo trial is to investigate the effectiveness of the caries infiltration technique for the repression of caries progression. Within the framework of this investigation it is intended that the hypothesis to be substantiated is that carious cavities, which have been treated with the caries… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proximal Caries
- What is being tested?
- Duraphat and Icon approximal caries infiltration kit
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Dec 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 years and older
- Good general health
- At least 2 active, approximal caries lesions present without evidence of frank cavitation Caries depth: E2 - D1 (minimum extension to the inner half of the enamel and maximum to the outer third of the dentin)
- The posterior teeth on the upper and lower arches from distal of the first premolar to mesial of the second molar will be included
- All teeth to be treated must have approximal contacts with the adjacent teeth in the arch
- Other teeth requiring treatment will be treated prior to the beginning of the trial
- The patients must declare their consent to participate in the clinical trial following the provision of the required clarifications regarding the method, significance and scope of the trial as well as the associated risks. They may withdraw this consent at any time.
- Participation in the follow-up examinations
Who cannot join
- - Parallel participation in a further trial relating to dental materials
- The patient has not signed the participant consent form
- Pregnant and breastfeeding women prior to the trial commencing A woman that becomes pregnant after the treatment has been performed will remain in the study, unless she becomes pregnant for a second time in which case, she will be excluded from the study
- Unexplained diseases of the mucous membranes or conditions in the sense of contact allergies to materials used, e.g. oral lichenoid lesions
- Known allergies to ingredients contained within the treatment materials used
- Infectious diseases such as HIV, hepatitis, etc
Show all 13Show fewer
- Undergoing orthodontic treatment at the time of the trial
- Persons who are presently taking other medication due to other illnesses, which upon our examination are deemed to possibly be a risk or a problem for the patient or the study
- A large number of existing carious lesions that have not been restored and would require extensive treatment, comprehensive prosthetic restorations that need to be done or replaced and severe periodontal disease
- Current use of bleaching products or use within the two weeks previous to the start of the study
- No assured dry isolation possible as required per the criteria of the adhesive technology (rubber dam system)
- Persons with a history of allergies
- Patients with dental treatment phobias
Trial locations and contacts
1 site in 1 country.
United States1 site
OHSU School of Dentistry / Department of Restorative Dentistry Oregon Health and Science University (OHSU)
Portland, Oregon, 97239
About this study
Official title: Long-term Bi-center Trial to Compare the Radiological Cavity Progression of Approximal Caries Following Infiltration or Standard Treatment
The aim of the planned in-vivo trial is to investigate the effectiveness of the caries infiltration technique for the repression of caries progression.
Within the framework of this investigation it is intended that the hypothesis to be substantiated is that carious cavities, which have been treated with the caries infiltration technique, exhibit significantly reduced radiological progression than those cavities that have been treated using standard preventive treatments.
Read more
In this multicenter trial, a total of 90 test subjects are included and 45 test subjects at each institution are to be treated with both, the infiltration technique and using conventional fluoridation treatment in different sides of the mouth ("split-mouth design").
The anticipated result of this trial shall deliver information on the long-term effectiveness of caries infiltration to prevent the progression of existing approximal carious lesions, and thereby enable an improvement in caries prevention within the scope of dental treatment.
Read the detailed description
The aim of the planned in-vivo trial is to investigate the effectiveness of the the caries infiltration technique for the repression of approximal caries progression. .
Within the framework of this investigation it is intended that the hypothesis be substantiated that carious cavities, which have been treated with the caries infiltration technique, exhibit significantly reduced radiological progression than those cavities that have been treated using standard treatments.
Modern dentistry, which is focused more towards preventive and minimally invasive treatment, attempts - with the aid of fluoride therapies and improved oral hygiene - to prevent the onset and progression of carious lesions as much as possible.
Even today, approximal lesions pose a particular problem to the treating dentist. A primary reason for this is the difficulty accessing the localized area of the carious cavity. Treating this area usually requires invasive treatment, in which healthy tooth structure must be removed. Furthermore, it is possible that the filling material may deteriorate as a result of the aging process, meaning that the restoration will require replacement at some point in the future. In order to prevent this, the development of a treatment oriented towards prevention and minimal invasion is key.
For a number of years there has been an option to seal pits and fissures on the occlusal surfaces, which is assessed in the literature as being highly efficacious and effective (Splieth et al. 2010, Ahovuo-Saloranta et al. 2008, Griffin et al. 2008). It constitutes a vital component of the caries prevention approach especially in the event of an increased risk of caries (Hiiri et al. 2010). In recent years there has been an attempt to transfer this treatment concept to applications in the approximal area, in order to prevent unnecessary substance ablation. A fissure sealing resin and a dental adhesive were used for the first time in an attempt at creating a surface diffusion barrier (Gomez et al. 2008, Gomez et al. 2005, Paris et al. 2006, Martignon et al. 2006, Robinson et al. 2001). Coating the tooth surface in the approximal area with various plastic foils after tooth separation opened up a whole new treatment approach for dealing with these carious lesions (Alkilzy et al. 2010, 2009).
The caries infiltration technique constitutes an additional new treatment concept. Here, the surface alone is not exclusively coated but a diffusion barrier is instead created inside the cavity itself, through the penetration of the "infiltrant" into the carious lesion (Paris et al. 2010, Meyer-Lueckel et al. 2010, 2009, 2008, Phark et al. 2009). In current studies, it has been possible to demonstrate inhibition of the progression of carious lesions with the infiltration technique, both in bovine teeth in situ and in artificially generated carious lesions in human teeth in vitro (Paris et al. 2010).
The development of the infiltration technique started back in the 1970's with the first low-viscosity plastic materials. However, these were never put into clinical application due to their toxicity (Robinson et al.1976). During their course of development, adhesive systems were employed for sealing carious lesions (Donly et al. 1992, Garcia-Godoy et al. 1997). These also exhibit a caries-inhibiting effect. However, it has only been possible to determine limited penetration depths. The reason for this is the surface morphology of the carious cavity, with a very limited pore volume on the surface, and the characteristics of the adhesive itself (Paris et al. 2007). In order to facilitate removal of the limiting surface layer, a hydrochloric acid gel was used for the infiltration technique in place of orthophosphoric acid gel for the adhesive technology. Using this conditioner it was possible to guarantee better penetration of the materials up to a depth of 58 µm due to an erosive removal of the surface layer (Meyer-Lueckel et al. 2007, Paris et al. 2007, 2009). In order to better utilize the capillary effect in the altered surface and to thereby increase the penetration depth of the material, monomer mixtures were developed with a high penetration coefficient. These enable a fast penetration of the infiltrant into the altered carious surface up to a depth of 750 µm (Paris et al. 2007, 2009). The sealing of the carious cavity is now no longer restricted to the surface alone, but also encompasses the body of the cavity.
The anticipated result of this trial shall deliver information on the long-term effectiveness of caries infiltration and thereby result in an improvement in caries prevention within the scope of dental treatment, and prevent the progression of existing carious lesions . This is a micro-invasive form of treatment, which largely facilitates the delay or avoidance of conventional invasive initial dental treatment with the associated inevitable loss of healthy tooth structure. Further studies on the optimization of the infiltration technique can be built upon these results. In the long-term, it will be possible to use these findings to develop new prevention and treatment options for approximal carious lesion .
- Conditions
- Proximal Caries
- Being tested
- Duraphat, Icon approximal caries infiltration kit
- Keywords
- caries, proximal, non-cavitated, fluoridation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuraphatDevice
Also called fluoride varnish
The subjects in the control group will be the subject of personalized oral hygiene instructions on the basis of obtained indices, and will also receive a professional prophylaxis. Following this, the surfaces of the teeth in the control group involved in the trial will be treated with a fluoride varnish (Duraphat®) that will be applied with a brush to all surfaces of the teeth, working the varnish approximally with the brush. This treatment will be repeated in the comparative group at each follow-up appointment.
Icon approximal caries infiltration kitDevice
Also called resin infiltration
Carious lesions in the teeth in the test group shall be treated with the infiltrant ICON® according to the manufacturer's instructions. Step by step instructions for application are as follows:
| Study group | Role | What they receive |
|---|---|---|
| Control (fluoride varnish) | Active comparator | Not described Receives: Device: Duraphat |
| resin infiltration (Icon) | Experimental | Not described Receives: Device: Icon approximal caries infiltration kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression of non-cavitated proximal caries lesions
preventing the progression of non-cavitated approximal lesions in comparison to conventional non invasive treatment; lesion progression will be monitored by annual bitewings and comparison to baseline lesion size
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proximal CariesStudies 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
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- DMG Dental Material Gesellschaft mbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dep. Conservtive Dentistry, Periodontology and Preventive Dentistry Hannover, Oregon Health and Science University
- Responsible party
- Sponsor
- Investigators
- Silke Jacker-Guhr, Dr., Principal investigator, Department of Conservtive Dentistry, Periodontology and PreventiveDentistry Hannover Medical SchoolAnne-Kathrin Lührs, Dr., Principal investigator, Department of Conservtive Dentistry, Periodontology and PreventiveDentistry Hannover Medical SchoolJack L Ferracane, Prof., Study chair, OHSU School of Dentistry / Department of Restorative Dentistry Oregon Health and Science University (OHSU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02191943
- Sponsor's protocol ID
- CHARM
- Status last verified
- Jul 2014
- First submitted
- 20 Jun 2014
- Last updated
- 26 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Bi-center Trial to Compare the Radiological Cavity Progression of Approximal Caries Following Infiltration or Standard Treatment
- ClinicalTrials.gov ID
- NCT02191943
- Acronym / sponsor ID
- CHARM
- Conditions
- Proximal Caries
- Keywords
- caries, proximal, non-cavitated, fluoridation
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- DMG Dental Material Gesellschaft mbHIndustry (pharma, biotech, devices)
- Collaborators
- Dep. Conservtive Dentistry, Periodontology and Preventive Dentistry Hannover, Oregon Health and Science University
- Study start
- Nov 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 16 Jul 2014 (estimated)
- 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 aim of the planned in-vivo trial is to investigate the effectiveness of the caries infiltration technique for the repression of caries progression.
Within the framework of this investigation it is intended that the hypothesis to be substantiated is that carious cavities, which have been treated with the caries infiltration technique, exhibit significantly reduced radiological progression than those cavities that have been treated using standard preventive treatments.
In this multicenter trial, a total of 90 test subjects are included and 45 test subjects at each institution are to be treated with both, the infiltration technique and using conventional fluoridation treatment in different sides of the mouth ("split-mouth design").
The anticipated result of this trial shall deliver information on the long-term effectiveness of caries infiltration to prevent the progression of existing approximal carious lesions, and thereby enable an improvement in caries prevention within the scope of dental treatment.
Detailed description
The aim of the planned in-vivo trial is to investigate the effectiveness of the the caries infiltration technique for the repression of approximal caries progression. .
Within the framework of this investigation it is intended that the hypothesis be substantiated that carious cavities, which have been treated with the caries infiltration technique, exhibit significantly reduced radiological progression than those cavities that have been treated using standard treatments.
Modern dentistry, which is focused more towards preventive and minimally invasive treatment, attempts - with the aid of fluoride therapies and improved oral hygiene - to prevent the onset and progression of carious lesions as much as possible.
Even today, approximal lesions pose a particular problem to the treating dentist. A primary reason for this is the difficulty accessing the localized area of the carious cavity. Treating this area usually requires invasive treatment, in which healthy tooth structure must be removed. Furthermore, it is possible that the filling material may deteriorate as a result of the aging process, meaning that the restoration will require replacement at some point in the future. In order to prevent this, the development of a treatment oriented towards prevention and minimal invasion is key.
For a number of years there has been an option to seal pits and fissures on the occlusal surfaces, which is assessed in the literature as being highly efficacious and effective (Splieth et al. 2010, Ahovuo-Saloranta et al. 2008, Griffin et al. 2008). It constitutes a vital component of the caries prevention approach especially in the event of an increased risk of caries (Hiiri et al. 2010). In recent years there has been an attempt to transfer this treatment concept to applications in the approximal area, in order to prevent unnecessary substance ablation. A fissure sealing resin and a dental adhesive were used for the first time in an attempt at creating a surface diffusion barrier (Gomez et al. 2008, Gomez et al. 2005, Paris et al. 2006, Martignon et al. 2006, Robinson et al. 2001). Coating the tooth surface in the approximal area with various plastic foils after tooth separation opened up a whole new treatment approach for dealing with these carious lesions (Alkilzy et al. 2010, 2009).
The caries infiltration technique constitutes an additional new treatment concept. Here, the surface alone is not exclusively coated but a diffusion barrier is instead created inside the cavity itself, through the penetration of the "infiltrant" into the carious lesion (Paris et al. 2010, Meyer-Lueckel et al. 2010, 2009, 2008, Phark et al. 2009). In current studies, it has been possible to demonstrate inhibition of the progression of carious lesions with the infiltration technique, both in bovine teeth in situ and in artificially generated carious lesions in human teeth in vitro (Paris et al. 2010).
The development of the infiltration technique started back in the 1970's with the first low-viscosity plastic materials. However, these were never put into clinical application due to their toxicity (Robinson et al.1976). During their course of development, adhesive systems were employed for sealing carious lesions (Donly et al. 1992, Garcia-Godoy et al. 1997). These also exhibit a caries-inhibiting effect. However, it has only been possible to determine limited penetration depths. The reason for this is the surface morphology of the carious cavity, with a very limited pore volume on the surface, and the characteristics of the adhesive itself (Paris et al. 2007). In order to facilitate removal of the limiting surface layer, a hydrochloric acid gel was used for the infiltration technique in place of orthophosphoric acid gel for the adhesive technology. Using this conditioner it was possible to guarantee better penetration of the materials up to a depth of 58 µm due to an erosive removal of the surface layer (Meyer-Lueckel et al. 2007, Paris et al. 2007, 2009). In order to better utilize the capillary effect in the altered surface and to thereby increase the penetration depth of the material, monomer mixtures were developed with a high penetration coefficient. These enable a fast penetration of the infiltrant into the altered carious surface up to a depth of 750 µm (Paris et al. 2007, 2009). The sealing of the carious cavity is now no longer restricted to the surface alone, but also encompasses the body of the cavity.
The anticipated result of this trial shall deliver information on the long-term effectiveness of caries infiltration and thereby result in an improvement in caries prevention within the scope of dental treatment, and prevent the progression of existing carious lesions . This is a micro-invasive form of treatment, which largely facilitates the delay or avoidance of conventional invasive initial dental treatment with the associated inevitable loss of healthy tooth structure. Further studies on the optimization of the infiltration technique can be built upon these results. In the long-term, it will be possible to use these findings to develop new prevention and treatment options for approximal carious lesion .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control (fluoride varnish) | Active comparator | Device: Duraphat |
| resin infiltration (Icon) | Experimental | Device: Icon approximal caries infiltration kit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age: 18 years and older
- Good general health
- At least 2 active, approximal caries lesions present without evidence of frank cavitation Caries depth: E2 - D1 (minimum extension to the inner half of the enamel and maximum to the outer third of the dentin)
- The posterior teeth on the upper and lower arches from distal of the first premolar to mesial of the second molar will be included
- All teeth to be treated must have approximal contacts with the adjacent teeth in the arch
Key exclusion criteria (13 listed)
- - Parallel participation in a further trial relating to dental materials
- The patient has not signed the participant consent form
- Pregnant and breastfeeding women prior to the trial commencing A woman that becomes pregnant after the treatment has been performed will remain in the study, unless she becomes pregnant for a second time in which case, she will be excluded from the study
- Unexplained diseases of the mucous membranes or conditions in the sense of contact allergies to materials used, e.g. oral lichenoid lesions
- Known allergies to ingredients contained within the treatment materials used
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 |
|---|---|---|
| DuraphatAlso: fluoride varnishThe subjects in the control group will be the subject of personalized oral hygiene instructions on the basis of obtained indices, and will also receive a professional prophylaxis. Following this, the surfaces of the teeth in the control group involved in the trial will be treated with a fluoride varnish (Duraphat®) that will be applied with a brush to all surfaces of the teeth, working the varnish approximally with the brush. This treatment will be repeated in the comparative group at each follow-up appointment. | Device | Control (fluoride varnish) |
| Icon approximal caries infiltration kitAlso: resin infiltrationCarious lesions in the teeth in the test group shall be treated with the infiltrant ICON® according to the manufacturer's instructions. Step by step instructions for application are as follows: | Device | resin infiltration (Icon) |
Primary outcome
progression of non-cavitated proximal caries lesions
Time frame: up to 36 months
preventing the progression of non-cavitated approximal lesions in comparison to conventional non invasive treatment; lesion progression will be monitored by annual bitewings and comparison to baseline lesion size
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2015.
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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.
Silke Jacker-Guhr, Dr. principal investigator
Department of Conservtive Dentistry, Periodontology and PreventiveDentistry Hannover Medical School
Anne-Kathrin Lührs, Dr. principal investigator
Department of Conservtive Dentistry, Periodontology and PreventiveDentistry Hannover Medical School
Jack L Ferracane, Prof. study chair
OHSU School of Dentistry / Department of Restorative Dentistry Oregon Health and Science University (OHSU)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Duraphat and Icon approximal caries infiltration kit in people with Proximal Caries, run by DMG Dental Material Gesellschaft mbH at 1 site in United States.
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 8 inclusion and 13 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: withdrawn, as of the sponsor's last update on 26 Jan 2015. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
progression of non-cavitated proximal caries lesions (time frame: up to 36 months). 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 26 Jan 2015.