CariesNCT01588210
Fluoride Concentration in Inter-proximal Fluid From Dental Sealants
A study testing Sealant application in people with Caries, run by Università degli Studi di Sassari at 2 sites in Italy.
Trial summary
The hypothesis of this study is that the concentration of fluoride in oral interproximal fluids would increase more after using high-viscosity GIC as pit and fissure sealant, compared to Resin-Based sealants containing fluoride and RB sealants without fluoride content. Read more about this study
- Who is it for?
- Ages 6 to 7 years
- Conditions the study is for
- Caries
- What is being tested?
- Sealant application
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,776 participants
- Where
- 2 sitesItaly
- Study dates
- Jan 2008to Jun 2010
- 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 6 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The inclusion criteria are: year of birth between 2000 and 2002, informed consent signed by parents/guardians, presence of at least two permanent first molars completely erupted.
Who cannot join
- The exclusion criteria are: demineralized lesions and hypomineralized permanent molar, carious lesions or presence of filling on the occlusal surface of the first permanent molar, fixed orthodontic treatment.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
WHO CC University of Milan
Milan, I-20121
Department of Surgery, Microsurgery and Medicine Sciences University of Sassari
Sassari, Sardinia, I-07100
About this study
Official title: Fluoride Concentration in Inter-proximal Fluid From Dental Sealants.
The hypothesis of this study is that the concentration of fluoride in oral interproximal fluids would increase more after using high-viscosity GIC as pit and fissure sealant, compared to Resin-Based sealants containing fluoride and RB sealants without fluoride content. To validate this hypothesis a randomized clinical trial was designed and performed in schoolchildren in order to evaluate fluoride release in inter-proximal fluid in vivo after the placement of three types of sealants: high-viscosity GIC, Resin-Based sealants containing fluoride and RB sealants without fluoride content.
- Conditions
- Caries
- Being tested
- Sealant application
- Keywords
- caries, sealant, fluoride, prevention, community dentistry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sealant applicationOther
A high-viscosity glass-ionomer cement (KETAC™ MOLAR APLICAP 3M Espe, Germany) will be used.
All sealants was applied following these steps: tooth isolation using cotton rolls or rubber dam; tooth cleaning using a rotary brush mounted on a low-speed contrangle with a prophylaxis pasta without fluoride; enamel etching using 37% phosphoric acid (H3PO4) for 30 seconds; rinse thoroughly with water and dry; placement a thin layer of sealant material and cure according to manufacturer's instructions and finally occlusion adjustment, if necessary.
sealant applicationOther
A white photopolymerizable Resin-Based sealant containing fluoride (Helioseal F®, Ivoclar Vivadent AG, Fürstentum Liechtenstein) will be used.
All sealants was applied following these steps: tooth isolation using cotton rolls or rubber dam (it was mandatory for both the RB sealants); tooth cleaning using a rotary brush mounted on a low-speed contrangle with a prophylaxis pasta without fluoride; enamel etching using 37% phosphoric acid (H3PO4) for 30 seconds; rinse thoroughly with water and dry; placement a thin layer of sealant material and cure according to manufacturer's instructions and finally occlusion adjustment, if necessary.
sealant applicationOther
A white photopolymerizable Resin-Based sealant (Concise 1930TM 3M Espe, Germany) will be used.
All sealants was applied following these steps: tooth isolation using cotton rolls or rubber dam (it was mandatory for both the RB sealants); tooth cleaning using a rotary brush mounted on a low-speed contrangle with a prophylaxis pasta without fluoride; enamel etching using 37% phosphoric acid (H3PO4) for 30 seconds; rinse thoroughly with water and dry; placement a thin layer of sealant material and cure according to manufacturer's instructions and finally occlusion adjustment, if necessary.
| Study group | Role | What they receive |
|---|---|---|
| Glass Ionomer Cement group | Experimental | a high-viscosity glass-ionomer cement (KETAC™ MOLAR APLICAP 3M Espe, Germany) Receives: Other: Sealant application |
| Resin Based Fluoride Group | Experimental | white photopolymerizable Resin-Based sealant containing fluoride (Helioseal F®, Ivoclar Vivadent AG, Fürstentum Liechtenstein) Receives: Other: sealant application |
| Resin Based sealant | Placebo comparator | white photopolymerizable Resin-Based sealant (Concise 1930TM 3M Espe, Germany) Receives: Other: sealant application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter-proximal fluid fluoride concentration
Inter-proximal fluid was collected with a paper point in the mesial inter-proximal space of the sealed tooth for 15 seconds. Each sample was prepared for the analysis as follow: added of 0.5 ml TISAB III to reach a pH 5 and shaken with magnetic stirrer thermostated at 25°C for 15 seconds. 100 ml of the solution was then placed on a Petri dish for the analysis. Fluoride concentration was carried out with an Orion model 96.09 fluoride ion selective electrode and an Orion model 900200 double junction plastic body Ag/AgCl reference electrode with an Orion model 290 mV digital meter.
Measured: 21 days after application
Secondary outcomes (1)
caries incidence
measurement of tooth caries at D1, D2 D3 level (both enamel and dentinal caries)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2012 (estimated)
- Study startJan 2008
- Primary completionMar 2008
- Study completionJun 2010
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 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 2,776 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Sassari
- Sponsor type
- University, hospital or other
- Collaborators
- World Health Organization
- Responsible party
- Principal investigator, Guglielmo Campus, Università degli Studi di Sassari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01588210
- Sponsor's protocol ID
- 20120-01
- Other IDs
- 2011-10-11
- Status last verified
- May 2012
- First submitted
- 26 Apr 2012
- Last updated
- 18 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Cagetti MG, Carta G, Cocco F, Sale S, Congiu G, Mura A, Strohmenger L, Lingstrom P, Campus G; Italian Experimental Group on Oral Health. Effect of Fluoridated Sealants on Adjacent Tooth Surfaces: A 30-mo Randomized Clinical Trial. J Dent Res. 2014 Jul;93(7 Suppl):59S-65S. doi: 10.1177/0022034514535808. Epub 2014 May 20.
PubMed 24846910Campus G, Carta G, Cagetti MG, Bossu M, Sale S, Cocco F, Conti G, Nardone M, Sanna G, Strohmenger L, Lingstrom P; Italian Experimental Group on Oral Health. Fluoride concentration from dental sealants: a randomized clinical trial. J Dent Res. 2013 Jul;92(7 Suppl):23S-8S. doi: 10.1177/0022034513484329. Epub 2013 May 20.
PubMed 23690357
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluoride Concentration in Inter-proximal Fluid From Dental Sealants.
- ClinicalTrials.gov ID
- NCT01588210
- Acronym / sponsor ID
- 20120-01
- Conditions
- Caries
- Keywords
- caries, sealant, fluoride, prevention, community dentistry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,776 participants (actual)
- Lead sponsor
- Università degli Studi di SassariUniversity, hospital or other
- Collaborators
- World Health Organization
- Study start
- Jan 2008
- Primary completion
- Mar 2008 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 30 Apr 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 hypothesis of this study is that the concentration of fluoride in oral interproximal fluids would increase more after using high-viscosity GIC as pit and fissure sealant, compared to Resin-Based sealants containing fluoride and RB sealants without fluoride content. To validate this hypothesis a randomized clinical trial was designed and performed in schoolchildren in order to evaluate fluoride release in inter-proximal fluid in vivo after the placement of three types of sealants: high-viscosity GIC, Resin-Based sealants containing fluoride and RB sealants without fluoride content.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Glass Ionomer Cement group | Experimental | Other: Sealant applicationa high-viscosity glass-ionomer cement (KETAC™ MOLAR APLICAP 3M Espe, Germany) |
| Resin Based Fluoride Group | Experimental | Other: sealant applicationwhite photopolymerizable Resin-Based sealant containing fluoride (Helioseal F®, Ivoclar Vivadent AG, Fürstentum Liechtenstein) |
| Resin Based sealant | Placebo comparator | Other: sealant applicationwhite photopolymerizable Resin-Based sealant (Concise 1930TM 3M Espe, Germany) |
Who may qualify
- Ages
- 6 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- The inclusion criteria are: year of birth between 2000 and 2002, informed consent signed by parents/guardians, presence of at least two permanent first molars completely erupted.
Key exclusion criteria (1 listed)
- The exclusion criteria are: demineralized lesions and hypomineralized permanent molar, carious lesions or presence of filling on the occlusal surface of the first permanent molar, fixed orthodontic treatment.
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 |
|---|---|---|
| Sealant applicationA high-viscosity glass-ionomer cement (KETAC™ MOLAR APLICAP 3M Espe, Germany) will be used. All sealants was applied following these steps: tooth isolation using cotton rolls or rubber dam; tooth cleaning using a rotary brush mounted on a low-speed contrangle with a prophylaxis pasta without fluoride; enamel etching using 37% phosphoric acid (H3PO4) for 30 seconds; rinse thoroughly with water and dry; placement a thin layer of sealant material and cure according to manufacturer's instructions and finally occlusion adjustment, if necessary. | Other | Glass Ionomer Cement group |
| sealant applicationA white photopolymerizable Resin-Based sealant containing fluoride (Helioseal F®, Ivoclar Vivadent AG, Fürstentum Liechtenstein) will be used. All sealants was applied following these steps: tooth isolation using cotton rolls or rubber dam (it was mandatory for both the RB sealants); tooth cleaning using a rotary brush mounted on a low-speed contrangle with a prophylaxis pasta without fluoride; enamel etching using 37% phosphoric acid (H3PO4) for 30 seconds; rinse thoroughly with water and dry; placement a thin layer of sealant material and cure according to manufacturer's instructions and finally occlusion adjustment, if necessary. | Other | Resin Based Fluoride Group |
| sealant applicationA white photopolymerizable Resin-Based sealant (Concise 1930TM 3M Espe, Germany) will be used. All sealants was applied following these steps: tooth isolation using cotton rolls or rubber dam (it was mandatory for both the RB sealants); tooth cleaning using a rotary brush mounted on a low-speed contrangle with a prophylaxis pasta without fluoride; enamel etching using 37% phosphoric acid (H3PO4) for 30 seconds; rinse thoroughly with water and dry; placement a thin layer of sealant material and cure according to manufacturer's instructions and finally occlusion adjustment, if necessary. | Other | Resin Based sealant |
Primary outcome
Inter-proximal fluid fluoride concentration
Time frame: 21 days after application
Inter-proximal fluid was collected with a paper point in the mesial inter-proximal space of the sealed tooth for 15 seconds. Each sample was prepared for the analysis as follow: added of 0.5 ml TISAB III to reach a pH 5 and shaken with magnetic stirrer thermostated at 25°C for 15 seconds. 100 ml of the solution was then placed on a Petri dish for the analysis. Fluoride concentration was carried out with an Orion model 96.09 fluoride ion selective electrode and an Orion model 900200 double junction plastic body Ag/AgCl reference electrode with an Orion model 290 mV digital meter.
1 secondary outcome
caries incidence
Time frame: 24 months
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 18 May 2012.
- Derived from this study: PubMed 24846910Cagetti MG, Carta G, Cocco F, Sale S, Congiu G, Mura A, Strohmenger L, Lingstrom P, Campus G; Italian Experimental Group on Oral Health. Effect of Fluoridated Sealants on Adjacent Tooth Surfaces: A 30-mo Randomized Clinical Trial. J Dent Res. 2014 Jul;93(7 Suppl):59S-65S. doi: 10.1177/0022034514535808. Epub 2014 May 20.
- Derived from this study: PubMed 23690357Campus G, Carta G, Cagetti MG, Bossu M, Sale S, Cocco F, Conti G, Nardone M, Sanna G, Strohmenger L, Lingstrom P; Italian Experimental Group on Oral Health. Fluoride concentration from dental sealants: a randomized clinical trial. J Dent Res. 2013 Jul;92(7 Suppl):23S-8S. doi: 10.1177/0022034513484329. Epub 2013 May 20.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sealant application in people with Caries, run by Università degli Studi di Sassari at 2 sites in Italy.
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 1 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 18 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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.
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?
Inter-proximal fluid fluoride concentration (time frame: 21 days after application). 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 NCT01588210, 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 18 May 2012.