Dental Caries in ChildrenNCT03886727
Effectiveness of Rubber Dam Isolation Versus Cotton Roll Isolation on Bonded Fissure Sealant Retention
A study testing Rubber Dam Set and Dental Cotton Roll in people with Dental Caries in Children and Dental Caries on Pit and Fissure Surface, run by Zafer Cavit Cehreli, DDS, PhD at 1 site in United States.
Trial summary
The purpose of this study is to evaluate and compare the clinical retention of bonded fissure sealants placed under rubber dam isolation and cotton roll isolation. 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 in Children, Dental Caries on Pit and Fissure Surface, Dental Leakage
- What is being tested?
- Rubber Dam Set and Dental Cotton Roll
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2020to 1 Jun 2021
- 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 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Teeth having a clinical indication of sealing with bonded resin pit and fissure sealants
- Patients with four fully-erupted permanent molars, with unstained, caries-free and unsealed pit and fissures
Who cannot join
- Patients having incipient carious lesions, fewer erupted molars or teeth without pits on buccal/palatal surfaces.
- Patients with systemic diseases.
Trial locations and contacts
1 site in 1 country.
United States1 site
LSU School of Dentistry, Department of Pediatric Dentistry
New Orleans, Louisiana, 70119
Sean M Sebourn, DDS, 504-941-8199, ssebou@lsuhsc.edu
Suzanne Fournier, DDS, 504-430-4300, sfour1@lsuhsc.edu
About this study
Official title: Clinical Retention of Bonded Resin Sealants Placed With Rubber Dam Versus Cotton Roll Isolation
The purpose of this study is to evaluate and compare the clinical retention of bonded fissure sealants placed under rubber dam isolation and cotton roll isolation.
- Being tested
- Rubber Dam Set, Dental Cotton Roll
- Medical subject headings
- Dental Leakage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rubber Dam SetDevice
Rubber dam set is the generic name of an isolation device that consists of a rubber sheet that isolates the tooth from saliva, a clamp to hold the rubber sheet on the tooth to be isolated, and a metal frame to keep the rubber sheet in a stretched position during dental procedures.
Dental Cotton RollDevice
Cotton roll is the generic name of a disposable isolation device made of cotton in a cylindrical form. Cotton rolls are used to isolate the teeth from saliva, by being placed in the cheek and tongue during placement of sealants or filings.
| Study group | Role | What they receive |
|---|---|---|
| Rubber Dam | Active comparator | Isolation of single tooth using rubber dam Receives: Device: Rubber Dam Set |
| Cotton Roll | Active comparator | Isolation of quadrant using cotton rolls Receives: Device: Dental Cotton Roll |
What is being measured
The primary outcome is the main question the study is designed to answer.
The US Public Health Service criteria for retention of sealants
Alpha: No Loss of sealant, Bravo: Partial Loss of Sealant, Charlie: Total loss of sealant
Measured: 12 months
Secondary outcomes (1)
The US Public Health Service criteria for secondary caries on sealants
Alpha: Charlie: There is no clinical diagnosis of caries. Charlie: There is clinical diagnosis of caries
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study start1 Feb 2020 (estimated)
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Caries in ChildrenStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zafer Cavit Cehreli, DDS, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zafer Cavit Cehreli, DDS, PhD, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03886727
- Sponsor's protocol ID
- RDI vs cotton roll
- Status last verified
- Nov 2019
- First submitted
- 21 Feb 2019
- Last updated
- 5 Nov 2019
- Results posted
- 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 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Retention of Bonded Resin Sealants Placed With Rubber Dam Versus Cotton Roll Isolation
- ClinicalTrials.gov ID
- NCT03886727
- Acronym / sponsor ID
- RDI vs cotton roll
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Zafer Cavit Cehreli, DDS, PhDUniversity, hospital or other
- Study start
- 1 Feb 2020 (estimated)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 22 Mar 2019 (actual)
- 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 is to evaluate and compare the clinical retention of bonded fissure sealants placed under rubber dam isolation and cotton roll isolation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rubber Dam | Active comparator | Device: Rubber Dam SetIsolation of single tooth using rubber dam |
| Cotton Roll | Active comparator | Device: Dental Cotton RollIsolation of quadrant using cotton rolls |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Teeth having a clinical indication of sealing with bonded resin pit and fissure sealants
- Patients with four fully-erupted permanent molars, with unstained, caries-free and unsealed pit and fissures
Key exclusion criteria (2 listed)
- Patients having incipient carious lesions, fewer erupted molars or teeth without pits on buccal/palatal surfaces.
- Patients with systemic diseases.
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 |
|---|---|---|
| Rubber Dam SetRubber dam set is the generic name of an isolation device that consists of a rubber sheet that isolates the tooth from saliva, a clamp to hold the rubber sheet on the tooth to be isolated, and a metal frame to keep the rubber sheet in a stretched position during dental procedures. | Device | Rubber Dam |
| Dental Cotton RollCotton roll is the generic name of a disposable isolation device made of cotton in a cylindrical form. Cotton rolls are used to isolate the teeth from saliva, by being placed in the cheek and tongue during placement of sealants or filings. | Device | Cotton Roll |
Primary outcome
The US Public Health Service criteria for retention of sealants
Time frame: 12 months
Alpha: No Loss of sealant, Bravo: Partial Loss of Sealant, Charlie: Total loss of sealant
1 secondary outcome
The US Public Health Service criteria for secondary caries on sealants
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2019.
- Individual participant dataSharing planned: No
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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.
LSU School of Dentistry, Department of Pediatric Dentistry
New Orleans, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rubber Dam Set and Dental Cotton Roll in people with Dental Caries in Children and Dental Caries on Pit and Fissure Surface, run by Zafer Cavit Cehreli, DDS, PhD 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 2 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: status not confirmed, as of the sponsor's last update on 5 Nov 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The US Public Health Service criteria for retention of sealants (time frame: 12 months). 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 5 Nov 2019.