Dental Caries on Pit and Fissure SurfaceNCT02668874
A Clinical Trial Comparing Isolite® vs. Cotton Roll Isolation in the Placement of Dental Sealants
A study testing Isolite System and Cotton Roll Technique in people with Dental Caries on Pit and Fissure Surface, run by University of Iowa at 1 site in United States.
Trial summary
The purpose of this split-mouth, randomized, controlled trial is to evaluate the retention rates of sealants placed under Isolite vs. cotton roll isolation. This study will also compare the patient and operator acceptability and satisfaction of the two isolation techniques as well as the time consumed for sealant… Read more about this study
- Who is it for?
- Ages 6 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries on Pit and Fissure Surface
- What is being tested?
- Isolite System and Cotton Roll Technique
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to 21 Aug 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy patients: American Society of Anesthesiologists (ASA) I or II
- Good cooperation: Frank1 3 or 4
- Aged between 6-16 years old at the day of sealant placement
- Minimum of two, maximum of sixteen, matched contralateral permanent molars or premolars.
Who cannot join
- Teeth with a history of past or current caries
- Teeth with a linical presentation of fluorosis, hypoplasia or any developmental anomalies
- Teeth with clinical or radiographic evidence of pathology
- Teeth with a history of restoration or sealant
- Patients who are poorly behaved
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa College of Dentistry and Dental Clinics
Iowa City, Iowa, 52242
About this study
Official title: A Clinical Trial Comparing Isolite® vs Cotton Roll Isolation in the Placement of Dental Sealants
The purpose of this split-mouth, randomized, controlled trial is to evaluate the retention rates of sealants placed under Isolite vs. cotton roll isolation. This study will also compare the patient and operator acceptability and satisfaction of the two isolation techniques as well as the time consumed for sealant application during the two isolation techniques.
Read the detailed description
104 regular patients at the College of Dentistry Department of Pediatric Dentistry Clinics, ages 6-16 years, will be invited to participate in this study. Matched contralateral pairs of first and second molars and premolars will be randomized to receive sealants with the use of the device (Isolite) for isolation or with the use of cotton roll isolation. All sealants will be placed by pediatric dentistry residents. Sealants will be placed on first and second permanent molars that have a matched contralateral molar requiring a sealant as well. Photographs may be taken of the sealants on the day of placement and at a 6-month and 12 month recalls. Retention of the sealants will be evaluated and scored by calibrated pediatric dentists.
- Conditions
- Dental Caries on Pit and Fissure Surface
- Being tested
- Isolite System, Cotton Roll Technique
- Keywords
- Pit and Fissure sealants, Isolation, permanent teeth, children, Isolite®, Dental caries
- Medical subject headings
- Van der Woude syndrome, Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isolite SystemDevice
Cotton Roll TechniqueOther
| Study group | Role | What they receive |
|---|---|---|
| Isolite System | Other | The Isolite technique utilizes a flexible plastic dental adapter to separate the cheek and tongue prior to sealant placement. Receives: Device: Isolite System |
| Cotton Roll technique | Other | A cotton roll is placed between the cheek and tongue prior to sealant placement. Receives: Other: Cotton Roll Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sealant Retention Percentage at 12 Months After Treatment
Physical examination will be done in order to determine if there is a percentage difference in retention rate of teeth, specifically 12 months after treatment.
Measured: 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study startFeb 2015
- Primary completion21 Aug 2017
- Study completion21 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dental Caries on Pit and Fissure SurfaceStudies 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
- Model description
- Simple randomization will be used for assignment of the treatment groups. Randomization: Two application methods will be used in each subject in order to place sealants, one using the Isolite system and one using the cotton roll system.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Collaborators
- Delta Dental of Iowa
- Responsible party
- Sponsor
- Investigators
- Shin, Study director, Director of Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02668874
- Sponsor's protocol ID
- 201502801
- Status last verified
- Jan 2022
- First submitted
- 10 Nov 2015
- Last updated
- 1 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial Comparing Isolite® vs Cotton Roll Isolation in the Placement of Dental Sealants
- ClinicalTrials.gov ID
- NCT02668874
- Acronym / sponsor ID
- 201502801
- Conditions
- Dental Caries on Pit and Fissure Surface
- Keywords
- Pit and Fissure sealants, Isolation, permanent teeth, children, Isolite®, Dental caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- Delta Dental of Iowa
- Study start
- Feb 2015
- Primary completion
- 21 Aug 2017 (actual)
- Study completion
- 21 Aug 2017 (actual)
- First posted
- 29 Jan 2016 (estimated)
- Results
- Posted 1 Feb 2022
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 split-mouth, randomized, controlled trial is to evaluate the retention rates of sealants placed under Isolite vs. cotton roll isolation. This study will also compare the patient and operator acceptability and satisfaction of the two isolation techniques as well as the time consumed for sealant application during the two isolation techniques.
Detailed description
104 regular patients at the College of Dentistry Department of Pediatric Dentistry Clinics, ages 6-16 years, will be invited to participate in this study. Matched contralateral pairs of first and second molars and premolars will be randomized to receive sealants with the use of the device (Isolite) for isolation or with the use of cotton roll isolation. All sealants will be placed by pediatric dentistry residents. Sealants will be placed on first and second permanent molars that have a matched contralateral molar requiring a sealant as well. Photographs may be taken of the sealants on the day of placement and at a 6-month and 12 month recalls. Retention of the sealants will be evaluated and scored by calibrated pediatric dentists.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Simple randomization will be used for assignment of the treatment groups. Randomization: Two application methods will be used in each subject in order to place sealants, one using the Isolite system and one using the cotton roll system.
| Arm | Type | Receives |
|---|---|---|
| Isolite System | Other | Device: Isolite SystemThe Isolite technique utilizes a flexible plastic dental adapter to separate the cheek and tongue prior to sealant placement. |
| Cotton Roll technique | Other | Other: Cotton Roll TechniqueA cotton roll is placed between the cheek and tongue prior to sealant placement. |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy patients: American Society of Anesthesiologists (ASA) I or II
- Good cooperation: Frank1 3 or 4
- Aged between 6-16 years old at the day of sealant placement
- Minimum of two, maximum of sixteen, matched contralateral permanent molars or premolars.
Key exclusion criteria (5 listed)
- Teeth with a history of past or current caries
- Teeth with a linical presentation of fluorosis, hypoplasia or any developmental anomalies
- Teeth with clinical or radiographic evidence of pathology
- Teeth with a history of restoration or sealant
- Patients who are poorly behaved
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 |
|---|---|---|
| Isolite System | Device | Isolite System |
| Cotton Roll Technique | Other | Cotton Roll technique |
Primary outcome
Sealant Retention Percentage at 12 Months After Treatment
Time frame: 12 months after treatment
Physical examination will be done in order to determine if there is a percentage difference in retention rate of teeth, specifically 12 months after treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
Shin study director
Director of Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isolite System and Cotton Roll Technique in people with Dental Caries on Pit and Fissure Surface, run by University of Iowa 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 4 inclusion and 5 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 1 Feb 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 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?
Yes. Results are posted in the registry (first posted 1 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Sealant Retention Percentage at 12 Months After Treatment (time frame: 12 months after treatment). 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 1 Feb 2022.