Dental CariesPhase 2/3NCT01417832
Radiographic Progression of Sealed and Infiltrated Caries Lesions in Vivo
A Phase 2/3 study testing Resin infiltration / adhesive in people with Dental Caries, run by Universidad El Bosque, Bogotá at 1 site in Colombia.
Trial summary
The purpose of this study was to compare with a clinical randomized controlled split-mouth design study the changes in the therapeutic effect of infiltrating versus sealing proximal caries lesions and placebo treatment after 1, 2 and 3 years. The outcome was lesion progression, evaluated by radiographic techniques. Read more about this study
- Who is it for?
- Ages 16 to 35 years
- Conditions the study is for
- Dental Caries
- What is being tested?
- Resin infiltration / adhesive
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteColombia
- Study dates
- Jan 2008to Mar 2011
- Phase
- Phase 2/3
- 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 16 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Subjects were to have at least three caries proximal lesions on their posterior permanent teeth with a radiographic severity classification of the lesion score of 3 -Around the enamel dentin junction (EDJ) or 4 -Dentin-outer 1/3.
Who cannot join
- Under orthodontic treatment at enrollment
- Moving from the city (Bogota) in the following three years after commencing the study.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study was to compare with a clinical randomized controlled split-mouth design study the changes in the therapeutic effect of infiltrating versus sealing proximal caries lesions and placebo treatment after 1, 2 and 3 years. The outcome was lesion progression, evaluated by radiographic techniques.
Read the detailed description
Fissure sealing has been shown to inhibit not only the formation of occlusal caries but also to impede the progression of existing caries lesions. Lately, the concept of sealing caries to arrest lesion progression has been transferred to approximal surfaces. In a clinical study sealed approximal lesions showed significantly reduced progression after 18 month compared with those that were treated only with preventive measures.
The pores of enamel caries lesions provide diffusion pathways for acids and dissolved minerals. The aim of caries infiltration is to occlude these pores by infiltration with light curing resins in order to block the diffusion of acids into the lesion body. In contrast to caries sealing, caries infiltration aims to occlude the pores within the lesion rather then placing a diffusion barrier on the lesion surface. Several studies showed significantly reduced progression of infiltrated enamel lesions in demineralizing environments.
This split-mouth placebo-controlled randomized clinical trial was conducted on 16-35 year-old subjects in Bogotá, Colombia (IRB UB.162-2008).
The sample size calculated was of minimum 29 patients with 3 approximal lesions around the EDJ or in the dentin outer third.
The study population was students and patients from Unversidad El Bosque. Two visits were planned for the patients within same week. In the first visit baseline standardized bitewing radiographs were obtained and 3 proximal selected lesions were randomly selected. A clinical examination was conducted to assess DMF-T/S, and individual caries risk. Elastic orthodontic bands were placed between teeth of selected surfaces for elective temporary separation.
In the second visit selected lesions were visually classified with ICDAS criteria and activity status of lesions was assessed. The 3 lesions were randomly allocated to: A. Infiltration, B. Sealing, C. Placebo, and lesions were treated.
Subjects were clinically examined after one, two, and three years by two examiners (AC, JSL) blinded to the selected treatment groups and referral for operative treatment were done if needed. Standardized bitewing radiographs were made each year.
Lesions progression was assessed on radiographs by pair-wise reading by an external examiner blinded to groups. Additionally, after one year reading of images was conducted by digital-subtraction radiography of scanned images. For reproducibility assessment the examiner repeated 20% of radiograph readings by both methods one week after the first reading.
Statistical analysis Intra-examiner reliability for radiographs readings was assessed by unweighted kappa scores; caries experience (DMF-T/S), individual caries risk levels, ICDAS criteria, radiographic scores, and progression' status of selected lesions were reported descriptively.
The outcome variable of changes in lesion progression after 1, 2 and 3 years was assessed by pair-wise radiographic reading and after one year also by digital-subtraction radiography.
Differences in lesion progression between treatments at each follow-up were tested by the Cochran Q test and in case of significant difference between groups, by the McNemar Change test, including the therapeutic effect and the 95% confidence intervals [Siegel \& Castellan, 1988].
In all tests p-values less than 0.05 were considered significant.
- Conditions
- Dental Caries
- Being tested
- Resin infiltration / adhesive, Placebo
- Keywords
- Dental caries, Proximal surfaces, Preventive therapy, Dental radiography, Treatment efficacy, Young adults
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resin infiltration / adhesiveDrug
Also called Infiltrant: Icon pre-product, DMG, Adhesive: Prime Bond NT, Dentsply
Treatment at baseline of one caries lesion with a resin infiltration conducted under rubber-dam isolation with the Icon-DMG pre-product; treatment at baseline of another caries lesion with an adhesive under rubber-dam isolation with the Prime Bont NT - Dentsply.
PlaceboDrug
Also called Placebo (cleaning of surface)
In this split-mouth design study, one of the three randomly selected approximal lesions will be treated with an infiltrant resin, one will be treated with an adhesive resin.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with Infiltrant/Adhesive | Experimental | In this split-mouth design study, one of the three randomly selected approximal lesions will be treated with an infiltrant resin, one will be treated with an adhesive resin. Receives: Drug: Resin infiltration / adhesive |
| Placebo, placebo treatment | Placebo comparator | In this split-mouth design study, one of the three randomly selected approximal lesions will be treated with a placebo treatment: At baseline one caries lesion was cleaned with a microbrush for 30 seconds and the procedure was repeated after two minutes. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pair-wise radiographic lesion progression
Changes in the therapeutic effect of infiltrating versus sealing proximal caries lesions and placebo treatment after 1, 2 and 3 years. The outcome was lesion progression, evaluated by radiographic techniques.
Measured: 1, 2, and 3 years
Secondary outcomes (1)
Digital-subtraction radiography lesion progression
Changes in the therapeutic effect of infiltrating versus sealing proximal caries lesions and placebo treatment after 1 year. The outcome was lesion progression, evaluated by subtraction radiography.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2011 (estimated)
- Study startJan 2008
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Dental 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad El Bosque, Bogotá
- Sponsor type
- University, hospital or other
- Collaborators
- DMG, Germany
- Investigators
- Stefania Martignon, PhD, Study chair, Universidad El Bosque, Bogotá, COlombia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01417832
- Sponsor's protocol ID
- DOC_20080328131018
- Status last verified
- Aug 2011
- First submitted
- 5 Jul 2011
- Last updated
- 16 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Martignon S, Ekstrand KR, Ellwood R. Efficacy of sealing proximal early active lesions: an 18-month clinical study evaluated by conventional and subtraction radiography. Caries Res. 2006;40(5):382-8. doi: 10.1159/000094282.
PubMed 16946605Martignon S, Tellez M, Santamaria RM, Gomez J, Ekstrand KR. Sealing distal proximal caries lesions in first primary molars: efficacy after 2.5 years. Caries Res. 2010;44(6):562-70. doi: 10.1159/000321986. Epub 2010 Nov 19.
PubMed 21088401Ekstrand KR, Bakhshandeh A, Martignon S. Treatment of proximal superficial caries lesions on primary molar teeth with resin infiltration and fluoride varnish versus fluoride varnish only: efficacy after 1 year. Caries Res. 2010;44(1):41-6. doi: 10.1159/000275573. Epub 2010 Jan 15.
PubMed 20090327Martignon S, Ekstrand KR, Gomez J, Lara JS, Cortes A. Infiltrating/sealing proximal caries lesions: a 3-year randomized clinical trial. J Dent Res. 2012 Mar;91(3):288-92. doi: 10.1177/0022034511435328. Epub 2012 Jan 17.
PubMed 22257664
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiographic Progression of Sealed and Infiltrated Caries Lesions in Vivo
- ClinicalTrials.gov ID
- NCT01417832
- Acronym / sponsor ID
- DOC_20080328131018
- Conditions
- Dental Caries
- Keywords
- Dental caries, Proximal surfaces, Preventive therapy, Dental radiography, Treatment efficacy, Young adults
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Universidad El Bosque, BogotáUniversity, hospital or other
- Collaborators
- DMG, Germany
- Study start
- Jan 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 16 Aug 2011 (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 purpose of this study was to compare with a clinical randomized controlled split-mouth design study the changes in the therapeutic effect of infiltrating versus sealing proximal caries lesions and placebo treatment after 1, 2 and 3 years. The outcome was lesion progression, evaluated by radiographic techniques.
Detailed description
Fissure sealing has been shown to inhibit not only the formation of occlusal caries but also to impede the progression of existing caries lesions. Lately, the concept of sealing caries to arrest lesion progression has been transferred to approximal surfaces. In a clinical study sealed approximal lesions showed significantly reduced progression after 18 month compared with those that were treated only with preventive measures.
The pores of enamel caries lesions provide diffusion pathways for acids and dissolved minerals. The aim of caries infiltration is to occlude these pores by infiltration with light curing resins in order to block the diffusion of acids into the lesion body. In contrast to caries sealing, caries infiltration aims to occlude the pores within the lesion rather then placing a diffusion barrier on the lesion surface. Several studies showed significantly reduced progression of infiltrated enamel lesions in demineralizing environments.
This split-mouth placebo-controlled randomized clinical trial was conducted on 16-35 year-old subjects in Bogotá, Colombia (IRB UB.162-2008).
The sample size calculated was of minimum 29 patients with 3 approximal lesions around the EDJ or in the dentin outer third.
The study population was students and patients from Unversidad El Bosque. Two visits were planned for the patients within same week. In the first visit baseline standardized bitewing radiographs were obtained and 3 proximal selected lesions were randomly selected. A clinical examination was conducted to assess DMF-T/S, and individual caries risk. Elastic orthodontic bands were placed between teeth of selected surfaces for elective temporary separation.
In the second visit selected lesions were visually classified with ICDAS criteria and activity status of lesions was assessed. The 3 lesions were randomly allocated to: A. Infiltration, B. Sealing, C. Placebo, and lesions were treated.
Subjects were clinically examined after one, two, and three years by two examiners (AC, JSL) blinded to the selected treatment groups and referral for operative treatment were done if needed. Standardized bitewing radiographs were made each year.
Lesions progression was assessed on radiographs by pair-wise reading by an external examiner blinded to groups. Additionally, after one year reading of images was conducted by digital-subtraction radiography of scanned images. For reproducibility assessment the examiner repeated 20% of radiograph readings by both methods one week after the first reading.
Statistical analysis Intra-examiner reliability for radiographs readings was assessed by unweighted kappa scores; caries experience (DMF-T/S), individual caries risk levels, ICDAS criteria, radiographic scores, and progression' status of selected lesions were reported descriptively.
The outcome variable of changes in lesion progression after 1, 2 and 3 years was assessed by pair-wise radiographic reading and after one year also by digital-subtraction radiography.
Differences in lesion progression between treatments at each follow-up were tested by the Cochran Q test and in case of significant difference between groups, by the McNemar Change test, including the therapeutic effect and the 95% confidence intervals [Siegel \& Castellan, 1988].
In all tests p-values less than 0.05 were considered significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment with Infiltrant/Adhesive | Experimental | Drug: Resin infiltration / adhesiveIn this split-mouth design study, one of the three randomly selected approximal lesions will be treated with an infiltrant resin, one will be treated with an adhesive resin. |
| Placebo, placebo treatment | Placebo comparator | Drug: PlaceboIn this split-mouth design study, one of the three randomly selected approximal lesions will be treated with a placebo treatment: At baseline one caries lesion was cleaned with a microbrush for 30 seconds and the procedure was repeated after two minutes. |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Subjects were to have at least three caries proximal lesions on their posterior permanent teeth with a radiographic severity classification of the lesion score of 3 -Around the enamel dentin junction (EDJ) or 4 -Dentin-outer 1/3.
Key exclusion criteria (2 listed)
- Under orthodontic treatment at enrollment
- Moving from the city (Bogota) in the following three years after commencing the study.
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 infiltration / adhesiveAlso: Infiltrant: Icon pre-product, DMG, Adhesive: Prime Bond NT, DentsplyTreatment at baseline of one caries lesion with a resin infiltration conducted under rubber-dam isolation with the Icon-DMG pre-product; treatment at baseline of another caries lesion with an adhesive under rubber-dam isolation with the Prime Bont NT - Dentsply. | Drug | Treatment with Infiltrant/Adhesive |
| PlaceboAlso: Placebo (cleaning of surface)In this split-mouth design study, one of the three randomly selected approximal lesions will be treated with an infiltrant resin, one will be treated with an adhesive resin. | Drug | Placebo, placebo treatment |
Primary outcome
Pair-wise radiographic lesion progression
Time frame: 1, 2, and 3 years
Changes in the therapeutic effect of infiltrating versus sealing proximal caries lesions and placebo treatment after 1, 2 and 3 years. The outcome was lesion progression, evaluated by radiographic techniques.
1 secondary outcome
Digital-subtraction radiography lesion progression
Time frame: 1 year
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 16 Aug 2011.
- Background: PubMed 16946605Martignon S, Ekstrand KR, Ellwood R. Efficacy of sealing proximal early active lesions: an 18-month clinical study evaluated by conventional and subtraction radiography. Caries Res. 2006;40(5):382-8. doi: 10.1159/000094282.
- Background: PubMed 21088401Martignon S, Tellez M, Santamaria RM, Gomez J, Ekstrand KR. Sealing distal proximal caries lesions in first primary molars: efficacy after 2.5 years. Caries Res. 2010;44(6):562-70. doi: 10.1159/000321986. Epub 2010 Nov 19.
- Background: PubMed 20090327Ekstrand KR, Bakhshandeh A, Martignon S. Treatment of proximal superficial caries lesions on primary molar teeth with resin infiltration and fluoride varnish versus fluoride varnish only: efficacy after 1 year. Caries Res. 2010;44(1):41-6. doi: 10.1159/000275573. Epub 2010 Jan 15.
- Derived from this study: PubMed 22257664Martignon S, Ekstrand KR, Gomez J, Lara JS, Cortes A. Infiltrating/sealing proximal caries lesions: a 3-year randomized clinical trial. J Dent Res. 2012 Mar;91(3):288-92. doi: 10.1177/0022034511435328. Epub 2012 Jan 17.
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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.
Stefania Martignon, PhD study chair
Universidad El Bosque, Bogotá, COlombia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Resin infiltration / adhesive in people with Dental Caries, run by Universidad El Bosque, Bogotá at 1 site in Colombia.
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 1 inclusion and 2 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 16 Aug 2011. 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 Colombia. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pair-wise radiographic lesion progression (time frame: 1, 2, and 3 years). 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 NCT01417832, which also lists 4 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 16 Aug 2011.