Dental CariesPhase 4PTPSNCT02338180
Preventive and Therapeutic Proximal Sealants
A Phase 4 study testing proximal preventive sealants and proximal therapeutic sealant in people with Dental Caries, run by Universidad de Valparaiso at 1 site in Chile.
Trial summary
It is of clinical importance to arrest the development of approximal caries at an early stage. The potential for initial caries to develop into manifest lesions has motivated studies on the use of sealants to arrest the progression of caries on both occlusal and approximal tooth surfaces. Read more about this study
- Who is it for?
- Ages 8 to 10 years
- Conditions the study is for
- Dental Caries
- What is being tested?
- proximal preventive sealants and proximal therapeutic sealant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 1 siteChile
- Study dates
- Mar 2009to Nov 2012
- Phase
- Phase 4
- 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 8 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children with high rate of caries in the primary dentition
- active caries on the distal surfaces of the second primary molars at least on both sides of the mouth
- children with no lesions on the adjacent tooth surfaces on the second primary and first permanent molars were included as a general control group
Who cannot join
- children using medication containing sucrose or with a negative effect on salivary flow
- children using orthodontic devices
- children who refuses to participate
Trial locations and contacts
1 site in 1 country.
Chile1 site
Dental Reference Center Simon Bolivar
Viña del Mar, Valparaiso, 2520000
About this study
Official title: A Randomized Clinical Trial on Preventive and Therapeutic Proximal Sealants
It is of clinical importance to arrest the development of approximal caries at an early stage. The potential for initial caries to develop into manifest lesions has motivated studies on the use of sealants to arrest the progression of caries on both occlusal and approximal tooth surfaces.
Therefore, the aim of the present study was to follow-up and examine after 3.5 years, the efficacy of sealing caries-free or non-cavitated mesial surfaces of first permanent molars abutting lesions on the distal surfaces of second primary molars. The null hypothesis tested here was that preventive and therapeutic sealants do not prevent the development or slow the progression of dental caries over a period of 3.5 years in comparison to non-sealed control surfaces.
Read the detailed description
The study population comprised 121 schoolchildren aged 8 to 10 years in a high-caries community in Valparaiso, Chile. They were examined clinically and radiographically, divided into 3 groups, and treated accordingly: children in Group A had no carious lesions on the approximal surfaces of 05d-6m and received no sealants; those in group B had active caries on 05d and received a preventive sealant on the caries-free 6m; and those in group C had active caries on 05d with an initial active lesion on 6m and received a therapeutic sealant on 6m. After 3.5 years, standardized follow-up radiographs were obtained for the children that remained.
- Conditions
- Dental Caries
- Being tested
- proximal preventive sealants, proximal therapeutic sealant
- Keywords
- dental caries, risk assessment, approximal sealant, permanent molar, preventive dentistry, adolescent
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
proximal preventive sealantsOther
Also called Concise Sealant (3M ESPE)
On sound mesial surfaces of first permanent molars adjacent to a caries active lesion of second primary molar, after 4-6 days with an orthodontic separating rubber ring around the approximal contact area. The test site was isolated with cotton rolls or a rubber dam. The surface of 6m was etched with 35% phosphoric acid for 20 sec, washed with water and then air-dried. The sealant (Concise Sealant; 3M ESPE) was applied and light-cured for 20 sec each on the occlusal, buccal and lingual sides. After polymerization, the sealant was inspected for complete coverage.
proximal therapeutic sealantOther
Also called Concise Sealant (3M ESPE)
On mesial surfaces of first permanent molars with caries active lesion adjacent to a caries active lesion of second primary molar , after 4-6 days with an orthodontic separating rubber ring around the approximal contact area. The test site was isolated with cotton rolls or a rubber dam. The surface of 6m was etched with 35% phosphoric acid for 20 sec, washed with water and then air-dried. The sealant (Concise Sealant; 3M ESPE) was applied and light-cured for 20 sec each on the occlusal, buccal and lingual sides. After polymerization, the sealant was inspected for complete coverage.
| Study group | Role | What they receive |
|---|---|---|
| Control group A | No intervention | Children with no caries lesion on adjacent surfaces of second primary molar and first permanent molar |
| Group B Preventive sealant | Experimental | Children with active caries lesion on distal surfaces of second primary molar and sound mesial surface of first permanent molar. In every children a split mouth design was applied, in one mesial surfaces of first molar randomize selected received a proximal preventive sealants, and the other remain as a control Receives: Other: proximal preventive sealants |
| Group C Therapeutic sealant | Experimental | Children with active caries lesion on distal surfaces of second primary molar and active lesion on mesial surface of first permanent molar. In every children a split mouth design was applied, in one mesial surfaces of first molar randomize selected received proximal therapeutic sealant, and the other remain as a control Receives: Other: proximal preventive sealants; Other: proximal therapeutic sealant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of active lesion developed on first molar mesial surfaces
Outcome will be measured by a radiographical examination (standardized posterior bitewings) 3.5 years after the preventive or therapeutical proximal sealants have been applied.
Measured: 3.5 years (42-44 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2015 (estimated)
- Study startMar 2009
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 390 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Valparaiso
- Sponsor type
- University, hospital or other
- Collaborators
- Göteborg University
- Responsible party
- Principal investigator, CRISTIAN BASILI, Universidad de Valparaiso
- Investigators
- Cristian P Basili, DDS, PHD, Principal investigator, University of Valparaiso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02338180
- Sponsor's protocol ID
- Project DIPUV 30/2007
- Acronym
- PTPS
- Status last verified
- Sep 2016
- First submitted
- 9 Jan 2015
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Martignon 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 22257664Ammari MM, Soviero VM, da Silva Fidalgo TK, Lenzi M, Ferreira DM, Mattos CT, de Souza IP, Maia LC. Is non-cavitated proximal lesion sealing an effective method for caries control in primary and permanent teeth? A systematic review and meta-analysis. J Dent. 2014 Oct;42(10):1217-27. doi: 10.1016/j.jdent.2014.07.015. Epub 2014 Jul 24.
PubMed 25066832Gomez SS, Basili CP, Emilson CG. A 2-year clinical evaluation of sealed noncavitated approximal posterior carious lesions in adolescents. Clin Oral Investig. 2005 Dec;9(4):239-43. doi: 10.1007/s00784-005-0010-7. Epub 2005 Sep 16.
PubMed 16167153
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial on Preventive and Therapeutic Proximal Sealants
- ClinicalTrials.gov ID
- NCT02338180
- Acronym / sponsor ID
- PTPS / Project DIPUV 30/2007
- Conditions
- Dental Caries
- Keywords
- dental caries, risk assessment, approximal sealant, permanent molar, preventive dentistry, adolescent
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 390 participants (actual)
- Lead sponsor
- Universidad de ValparaisoUniversity, hospital or other
- Collaborators
- Göteborg University
- Study start
- Mar 2009
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 14 Jan 2015 (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.
It is of clinical importance to arrest the development of approximal caries at an early stage. The potential for initial caries to develop into manifest lesions has motivated studies on the use of sealants to arrest the progression of caries on both occlusal and approximal tooth surfaces.
Therefore, the aim of the present study was to follow-up and examine after 3.5 years, the efficacy of sealing caries-free or non-cavitated mesial surfaces of first permanent molars abutting lesions on the distal surfaces of second primary molars. The null hypothesis tested here was that preventive and therapeutic sealants do not prevent the development or slow the progression of dental caries over a period of 3.5 years in comparison to non-sealed control surfaces.
Detailed description
The study population comprised 121 schoolchildren aged 8 to 10 years in a high-caries community in Valparaiso, Chile. They were examined clinically and radiographically, divided into 3 groups, and treated accordingly: children in Group A had no carious lesions on the approximal surfaces of 05d-6m and received no sealants; those in group B had active caries on 05d and received a preventive sealant on the caries-free 6m; and those in group C had active caries on 05d with an initial active lesion on 6m and received a therapeutic sealant on 6m. After 3.5 years, standardized follow-up radiographs were obtained for the children that remained.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group A | No intervention | –Children with no caries lesion on adjacent surfaces of second primary molar and first permanent molar |
| Group B Preventive sealant | Experimental | Other: proximal preventive sealantsChildren with active caries lesion on distal surfaces of second primary molar and sound mesial surface of first permanent molar. In every children a split mouth design was applied, in one mesial surfaces of first molar randomize selected received a proximal preventive sealants, and the other remain as a control |
| Group C Therapeutic sealant | Experimental | Other: proximal preventive sealants, Other: proximal therapeutic sealantChildren with active caries lesion on distal surfaces of second primary molar and active lesion on mesial surface of first permanent molar. In every children a split mouth design was applied, in one mesial surfaces of first molar randomize selected received proximal therapeutic sealant, and the other remain as a control |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- children with high rate of caries in the primary dentition
- active caries on the distal surfaces of the second primary molars at least on both sides of the mouth
- children with no lesions on the adjacent tooth surfaces on the second primary and first permanent molars were included as a general control group
Key exclusion criteria (3 listed)
- children using medication containing sucrose or with a negative effect on salivary flow
- children using orthodontic devices
- children who refuses to participate
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 |
|---|---|---|
| proximal preventive sealantsAlso: Concise Sealant (3M ESPE)On sound mesial surfaces of first permanent molars adjacent to a caries active lesion of second primary molar, after 4-6 days with an orthodontic separating rubber ring around the approximal contact area. The test site was isolated with cotton rolls or a rubber dam. The surface of 6m was etched with 35% phosphoric acid for 20 sec, washed with water and then air-dried. The sealant (Concise Sealant; 3M ESPE) was applied and light-cured for 20 sec each on the occlusal, buccal and lingual sides. After polymerization, the sealant was inspected for complete coverage. | Other | Group B Preventive sealant, Group C Therapeutic sealant |
| proximal therapeutic sealantAlso: Concise Sealant (3M ESPE)On mesial surfaces of first permanent molars with caries active lesion adjacent to a caries active lesion of second primary molar , after 4-6 days with an orthodontic separating rubber ring around the approximal contact area. The test site was isolated with cotton rolls or a rubber dam. The surface of 6m was etched with 35% phosphoric acid for 20 sec, washed with water and then air-dried. The sealant (Concise Sealant; 3M ESPE) was applied and light-cured for 20 sec each on the occlusal, buccal and lingual sides. After polymerization, the sealant was inspected for complete coverage. | Other | Group C Therapeutic sealant |
Primary outcome
Number of active lesion developed on first molar mesial surfaces
Time frame: 3.5 years (42-44 months)
Outcome will be measured by a radiographical examination (standardized posterior bitewings) 3.5 years after the preventive or therapeutical proximal sealants have been applied.
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 27 Sep 2016.
- Background: 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.
- Results publication: PubMed 25066832Ammari MM, Soviero VM, da Silva Fidalgo TK, Lenzi M, Ferreira DM, Mattos CT, de Souza IP, Maia LC. Is non-cavitated proximal lesion sealing an effective method for caries control in primary and permanent teeth? A systematic review and meta-analysis. J Dent. 2014 Oct;42(10):1217-27. doi: 10.1016/j.jdent.2014.07.015. Epub 2014 Jul 24.
- Results publication: PubMed 16167153Gomez SS, Basili CP, Emilson CG. A 2-year clinical evaluation of sealed noncavitated approximal posterior carious lesions in adolescents. Clin Oral Investig. 2005 Dec;9(4):239-43. doi: 10.1007/s00784-005-0010-7. Epub 2005 Sep 16.
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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.
Cristian P Basili, DDS, PHD principal investigator
University of Valparaiso
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing proximal preventive sealants and proximal therapeutic sealant in people with Dental Caries, run by Universidad de Valparaiso at 1 site in Chile.
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 27 Sep 2016. 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 Chile. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Number of active lesion developed on first molar mesial surfaces (time frame: 3.5 years (42-44 months)). 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 NCT02338180, which also lists 3 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 27 Sep 2016; AzTrials last refreshed its copy on 6 Nov 2026.