Dental HealthNCT01726179
Efficacy of Proximal Caries Infiltration
A study testing Resin infiltration in people with Dental Health and Caries, run by DMG Dental Material Gesellschaft mbH at 1 site in Brazil.
Trial summary
The goal of the project is to investigate the clinical efficacy of management of early caries lesions by resin infiltration and to further scrutinize the patient stress experiences. Read more about this study
- Who is it for?
- Ages 5 to 9 years
- Conditions the study is for
- Dental Health, Caries
- What is being tested?
- Resin infiltration
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2013to Dec 2018
- 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 5 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children with one tooth surface with active caries lesions
- two primary molars with proximal lesion detected on the x-ray (scores 2 (E2) or 3 (D1) in Mejàre et al. scoring system with less depth
- asigned informed consent.
Who cannot join
- children who do not cooperate during dental appointments
- primary molars supposed to exfoliate in less than two years
- lesions showing obvious cavitation or clear sings of inactivity
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade do Estado do Rio de Janeiro, Faculdade de Odontologia.
Rio de Janeiro, 20551-031
About this study
Official title: Efficacy of Resin Infiltration of Proximal Caries Lesions in Primary Molars: Randomized Clinical Trial
The goal of the project is to investigate the clinical efficacy of management of early caries lesions by resin infiltration and to further scrutinize the patient stress experiences.
Read the detailed description
The aim of this study is to test the clinical efficacy of caries infiltration to arrest proximal caries lesions in primary molars. It was hypothesized that infiltrated lesions (test lesions) will progress significantly less than non infiltrated lesions (control lesions). Additionally, it was hypothesized that dental anxiety and stress related to caries infiltration will be significantly less than dental anxiety related to a conventional restorative procedure. The study will be a controlled clinical trial with a split mouth design and blind evaluation of the outcome (caries progression). Caries progression will be evaluated annually, 12, 24, and 36 months after treatment.
- Conditions
- Dental Health, Caries
- Being tested
- Resin infiltration, Control
- Keywords
- caries infiltration, caries arrest, dental anxiety, dental stress, resin infiltration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resin infiltrationDevice
Also called Icon (DMG, Germany), Approximal resin infiltration kit
Proximal caries lesions that are selected for this intervention will be treated with the resin infiltrant Icon according to the manufacturer's instructions. In short, local anesthesia of the gingival papila, application of rubber dam, etching of the lesion surface for 120 s using 15%HCl gel, washing the lesion with water spray for 30 s, drying the lesion with 100% ethanol for 30 s and subsequent air blowing, application of the infiltrant for 180 s using an applicator provided with the kit, removing excess material from the lesion surface by air blowing and flossing, light curing of the infiltrant for 40 s, repeated application for 60 s, light curing for 40 s, polishing, and removal of the rubber dam.
ControlDevice
Proximal caries lesions do not recieve a placebo treatment, but simply left untreated.
| Study group | Role | What they receive |
|---|---|---|
| Resin infiltration | Experimental | This study is a split mouth design. One tooth with a proximal caries lesion is randomized into this arm and another tooth to the arm "Control". Teeth in this arm are treated by the resin infiltration technique using Icon (DMG, Germany) according to manufactures´ instructions. In addition patients and their guardians are instructed to floss once a day and to brush with fluoridated toothpaste twice a day.
Digital bitewing radiographs will be taken at baseline and repeated after 12 months. Additionally caries risk will be evaluated. Receives: Device: Resin infiltration |
| Control | Other | This study is a split mouth design. One tooth with a proximal caries lesion is randomized into this arm and another tooth to the arm "Resin infiltration". Teeth randomized into this arm do not recieve any special treatment except general oral nonivasiv treatment (flossing and brushing). Patients and their guardians are instructed to floss once a day and to brush with fluoridated toothpaste twice a day.
Digital bitewing radiographs will be taken at baseline and repeated after 12 months. Additionally caries risk will be evaluated. Receives: Device: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caries progression rate
Radiographic evaluation of infiltrated and control caries lesions to evaluate caries progression. This is done by pairwise comparison of digital bitewing radiographs by one calibrated, blinded examiner.
Measured: 1 year
Secondary outcomes (3)
Stress reaction during treatment
To evaluate dental anxiety and stress reactions in relation to the caries infiltration procedure in comparison with a dental examination appointment and conventional resin restoration appointment.
A facial image scale with five faces ranging from very happy (1) to very unhappy (5) will be used.
Measured: Immediate
Caries risk
Caries risk is asses based on caries index (Nyvad criteria), proximal plaque index (0 = no visible plaque; 1 = visible plaque) and gingival bleeding index (0 = no bleeding after flossing; 1 = bleeding after flossing), dietary habits, and exposition to fluorides based on the Cariogram model.
Measured: Baseline, 6 months, 1 year, 2 years, 3 years
Caries progression rate
Radiographic evaluation of infiltrated and control caries lesions to evaluate caries progression in long term. This is done by pairwise comparison of digital bitewing radiographs by one calibrated, blinded examiner.
Measured: 2 years, 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2012 (estimated)
- Study startDec 2013
- Primary completionDec 2017
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dental HealthStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- DMG Dental Material Gesellschaft mbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Universidade Federal do Rio de Janeiro, Rio de Janeiro State Research Supporting Foundation (FAPERJ)
- Responsible party
- Sponsor
- Investigators
- Vera M Soviero, Prof., Dr., Principal investigator, Universidade do Estado do Rio de Janeiro, Faculdade de Odontologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01726179
- Sponsor's protocol ID
- ECIPRJ13
- Status last verified
- Apr 2022
- First submitted
- 1 Nov 2012
- Last updated
- 26 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Ammari MM, Jorge RC, Souza IPR, Soviero VM. Efficacy of resin infiltration of proximal caries in primary molars: 1-year follow-up of a split-mouth randomized controlled clinical trial. Clin Oral Investig. 2018 Apr;22(3):1355-1362. doi: 10.1007/s00784-017-2227-7. Epub 2017 Oct 8.
PubMed 28990122Jorge RC, Ammari MM, Soviero VM, Souza IPR. Randomized controlled clinical trial of resin infiltration in primary molars: 2 years follow-up. J Dent. 2019 Nov;90:103184. doi: 10.1016/j.jdent.2019.103184. Epub 2019 Aug 26.
PubMed 31465818
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Resin Infiltration of Proximal Caries Lesions in Primary Molars: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01726179
- Acronym / sponsor ID
- ECIPRJ13
- Conditions
- Dental Health, Caries
- Keywords
- caries infiltration, caries arrest, dental anxiety, dental stress, resin infiltration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- DMG Dental Material Gesellschaft mbHIndustry (pharma, biotech, devices)
- Collaborators
- Universidade Federal do Rio de Janeiro, Rio de Janeiro State Research Supporting Foundation (FAPERJ)
- Study start
- Dec 2013 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 14 Nov 2012 (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 goal of the project is to investigate the clinical efficacy of management of early caries lesions by resin infiltration and to further scrutinize the patient stress experiences.
Detailed description
The aim of this study is to test the clinical efficacy of caries infiltration to arrest proximal caries lesions in primary molars. It was hypothesized that infiltrated lesions (test lesions) will progress significantly less than non infiltrated lesions (control lesions). Additionally, it was hypothesized that dental anxiety and stress related to caries infiltration will be significantly less than dental anxiety related to a conventional restorative procedure. The study will be a controlled clinical trial with a split mouth design and blind evaluation of the outcome (caries progression). Caries progression will be evaluated annually, 12, 24, and 36 months after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resin infiltration | Experimental | Device: Resin infiltrationThis study is a split mouth design. One tooth with a proximal caries lesion is randomized into this arm and another tooth to the arm "Control". Teeth in this arm are treated by the resin infiltration technique using Icon (DMG, Germany) according to manufactures´ instructions. In addition patients and their guardians are instructed to floss once a day and to brush with fluoridated toothpaste twice a day. Digital bitewing radiographs will be taken at baseline and repeated after 12 months. Additionally caries risk will be evaluated. |
| Control | Other | Device: ControlThis study is a split mouth design. One tooth with a proximal caries lesion is randomized into this arm and another tooth to the arm "Resin infiltration". Teeth randomized into this arm do not recieve any special treatment except general oral nonivasiv treatment (flossing and brushing). Patients and their guardians are instructed to floss once a day and to brush with fluoridated toothpaste twice a day. Digital bitewing radiographs will be taken at baseline and repeated after 12 months. Additionally caries risk will be evaluated. |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- children with one tooth surface with active caries lesions
- two primary molars with proximal lesion detected on the x-ray (scores 2 (E2) or 3 (D1) in Mejàre et al. scoring system with less depth
- asigned informed consent.
Key exclusion criteria (3 listed)
- children who do not cooperate during dental appointments
- primary molars supposed to exfoliate in less than two years
- lesions showing obvious cavitation or clear sings of inactivity
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 |
|---|---|---|
| Resin infiltrationAlso: Icon (DMG, Germany), Approximal resin infiltration kitProximal caries lesions that are selected for this intervention will be treated with the resin infiltrant Icon according to the manufacturer's instructions. In short, local anesthesia of the gingival papila, application of rubber dam, etching of the lesion surface for 120 s using 15%HCl gel, washing the lesion with water spray for 30 s, drying the lesion with 100% ethanol for 30 s and subsequent air blowing, application of the infiltrant for 180 s using an applicator provided with the kit, removing excess material from the lesion surface by air blowing and flossing, light curing of the infiltrant for 40 s, repeated application for 60 s, light curing for 40 s, polishing, and removal of the rubber dam. | Device | Resin infiltration |
| ControlProximal caries lesions do not recieve a placebo treatment, but simply left untreated. | Device | Control |
Primary outcome
Caries progression rate
Time frame: 1 year
Radiographic evaluation of infiltrated and control caries lesions to evaluate caries progression. This is done by pairwise comparison of digital bitewing radiographs by one calibrated, blinded examiner.
3 secondary outcomes
Stress reaction during treatment
Time frame: Immediate
Caries risk
Time frame: Baseline, 6 months, 1 year, 2 years, 3 years
Caries progression rate
Time frame: 2 years, 3 years
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 26 Apr 2022.
- Results publication: PubMed 28990122Ammari MM, Jorge RC, Souza IPR, Soviero VM. Efficacy of resin infiltration of proximal caries in primary molars: 1-year follow-up of a split-mouth randomized controlled clinical trial. Clin Oral Investig. 2018 Apr;22(3):1355-1362. doi: 10.1007/s00784-017-2227-7. Epub 2017 Oct 8.
- Results publication: PubMed 31465818Jorge RC, Ammari MM, Soviero VM, Souza IPR. Randomized controlled clinical trial of resin infiltration in primary molars: 2 years follow-up. J Dent. 2019 Nov;90:103184. doi: 10.1016/j.jdent.2019.103184. Epub 2019 Aug 26.
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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.
Vera M Soviero, Prof., Dr. principal investigator
Universidade do Estado do Rio de Janeiro, Faculdade de Odontologia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resin infiltration in people with Dental Health and Caries, run by DMG Dental Material Gesellschaft mbH at 1 site in Brazil.
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 3 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: finished, as of the sponsor's last update on 26 Apr 2022. 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 Brazil. 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?
Caries progression rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01726179, which also lists 2 linked publications.
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 Apr 2022.