RetentionNCT05749991
Efficacy and Retention of Sealants Placement Using Two Isolation Systems
A study testing Dryshield and Cotton roll isolation in people with Retention and Time, run by Kuwait University at 1 site in Kuwait.
Trial summary
The trial aimed to evaluate the sealant retention, patient's preference and chair time needed during pit and fissure sealant placement under two isolation techniques [Dryshield system (DS) and cotton roll isolation (CRI)] in a university setting. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Retention, Time, Patient Preference
- What is being tested?
- Dryshield and Cotton roll isolation
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteKuwait
- Study dates
- 3 Jun 2018to 25 Feb 2020
- 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy patients with no compromising medical or physical condition
- age ranging from six to 12 years old;
- patients with at least one caries-free permanent molar in any quadrant, with normal anatomy, who qualified for pit and fissure sealant application with an International Caries Detection and Assessment System (ICDAS) score of 0-2.
- no prior sealants or restorations on the teeth under study;
- no cavitated carious lesions;
- cooperative patients (classified as 3 or 4 according to the Frankl Behavioral Rating Scale)
- legal guardian consents and approved assents to the child's participation in the study.
Who cannot join
- a history of chronic disease (e.g., epilepsy, ectodermal dysplasia, cardiac anomalies);
- inability to return for follow-ups.
- patients with molars that have partially erupted
- a permanent molar with enamel flaws or abnormal anatomy
- children who are uncooperative, with a Frankl Behaviour Rating Scale of 1 or 2;
- children who have a severe gagging reflex;
- special needs children.
- Those who do not provide appropriate assents or consents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Clinical Trial Comparing Fissure Sealant Retention Rate, Chair Time, and Patients' Preference Using Dryshield and Cotton Roll Isolation
The trial aimed to evaluate the sealant retention, patient's preference and chair time needed during pit and fissure sealant placement under two isolation techniques [Dryshield system (DS) and cotton roll isolation (CRI)] in a university setting.
Read the detailed description
In children, 80-90% of dental caries is found in the pits and fissures of the posterior permanent teeth. Pit and fissure sealants (PFS) can be used effectively to prevent dental caries. When applied correctly, dental PFS accomplish three main objectives: preventing dental caries development, hindering dental caries development in its initial phases, and inhibiting the spread of bacteria that cause dental caries. To be effective, PFS need to be applied under sufficient moisture control around the specific teeth undergoing treatment. Therefore, proper isolation of the teeth is one of the most important steps when placing sealants to ensure their retention.
Cotton roll isolation (CRI) has been widely used for sealant placement, and is the most common method among pediatric dentists. However, the placement of cotton rolls on the lateral part of the tongue or inadequate isolation during CRI has both been reported to produce gagging, tasting the contents and requiring frequent replacement of the wet cotton rolls.
A previous study demonstrated that new moisture control systems such as Isolite, produce sealant retention rates comparable to cotton roll isolation, while decreasing procedure time. DryShield (DS) has recently been introduced as an all-in-one isolation system. It is similar to the Isolite as it combines the tasks of fluid evacuation, tongue and cheek retraction, and serves as a bite block, but differs in that it is autoclavable and does not provide illumination. Its design allows it to suction and isolate half the oral cavity at a time. Therefore, it should presumably facilitate sealants placement under a more controlled environment, while reducing chair time for the dentist.
Few trials have compared the PFS chair time and patient acceptance of DS to the CRI. The goals of this study were to evaluate patients' preferences, time efficiency, and retention of PFS using DS compared to CRI in a single randomized clinical study.
- Conditions
- Retention, Time, Patient Preference
- Being tested
- Dryshield, Cotton roll isolation
- Medical subject headings
- Patient Preference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DryshieldDevice
DryShield combines the tasks of high-suction evacuator, saliva ejector, bite block, tongue shield, and oral pathway protector in one easy-to-use device.
The DryShield solution® is a patented autoclavable isolation system (MA, USA)
Cotton roll isolationDevice
Also called Cotton roll
Cotton Roll Isolation requires placing cotton rolls along the buccal mucosa, especially over the parotid glands ducts for maxillary teeth. For the mandibular teeth, the cotton rolls are placed in the buccal vestibule and the floor of the mouth (between the lower buccal mucosa and underneath and/or between the tongue). With this technique, a high-speed evacuation of saliva and water is used.
| Study group | Role | What they receive |
|---|---|---|
| DryShield Isolation | Experimental | Device: Dryshield DryShield (DS) is an all-in-one isolation system. It combines the tasks of fluid evacuation, tongue and cheek retraction, and serves as a bite block. Its design allows it to suction and isolate half the oral cavity at a time. Dryshield was used to isolate teeth that required sealant placement in the assigned participants. Receives: Device: Dryshield |
| Cotton Roll Isolation | Active comparator | Cotton Roll Isolation requires placing cotton rolls along the buccal mucosa, especially over the parotid glands ducts for maxillary teeth. For the mandibular teeth, the cotton rolls are placed in the buccal vestibule and the floor of the mouth (between the lower buccal mucosa and underneath and/or between the tongue).
Cotton roll isolation was used to isolate teeth that required sealant placement in the assigned participants.
With this technique, a high-speed evacuation of saliva and water is used. Receives: Device: Cotton roll isolation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fissure Sealant Retention at 6 months
Patients were clinically evaluated by a study supervisor as a blinded outcome assessor after 6 months of sealant placement. The evaluation was according to Simonsen's criteria: Completely retained, Partially retained, or Missing.
Measured: Change in sealant retention at 6 months
Change in Fissure Sealant Retention at 12 months
Patients were clinically evaluated by a study supervisor as a blinded outcome assessor after 12 months of sealant placement. The evaluation was according to Simonsen's criteria: Completely retained, Partially retained, or Missing.
Measured: Change in sealant retention at 12 months
Change in Fissure Sealant Retention at 18 months
assessor after 18 months of sealant placement. The evaluation was according to Simonsen's criteria: Completely retained, Partially retained, or Missing.
Measured: Change in sealant retention at 18 months
Secondary outcomes (2)
Placement time of sealants using Dryshield vs Cotton roll isolation
The placement time for sealant application was recorded with a stopwatch by the dental assistant as follows for the two techniques: the insertion of the isolation aids (DS or CRI) in the oral cavity constituted the start time, and the end time was when the isolation system was completely removed from the participant's mouth after the sealants application.
Measured: 0 Day (After the completion of initial sealant placement and removal of the isolation device)
Patient preference for Dryshield or Cotton roll isolation
A six-item interview-based questionnaire was administered to assess participants' acceptance of the isolation technique used.
Measured: 0 Day (After the completion of initial sealant placement and removal of the isolation device)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start3 Jun 2018
- Primary completion9 Feb 2020
- Study completion25 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for RetentionStudies 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
- Model description
- All eligible study participants were randomised using simple block random allocation to ensure balanced randomization for each isolation system. Each participant was given an envelope and a printed participant number. Each number identified the isolation technique used for sealant placement and the isolation application sequence to be used.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuwait University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ABRAR ALANZI, Kuwait University
- Investigators
- Abrar N Alanzi, Principal investigator, Kuwait University -Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05749991
- Sponsor's protocol ID
- VDR/EC/3344
- Status last verified
- Feb 2023
- First submitted
- 23 Jan 2023
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ahovuo-Saloranta A, Forss H, Walsh T, Nordblad A, Makela M, Worthington HV. Pit and fissure sealants for preventing dental decay in permanent teeth. Cochrane Database Syst Rev. 2017 Jul 31;7(7):CD001830. doi: 10.1002/14651858.CD001830.pub5.
PubMed 28759120Jenson L, Budenz AW, Featherstone JD, Ramos-Gomez FJ, Spolsky VW, Young DA. Clinical protocols for caries management by risk assessment. J Calif Dent Assoc. 2007 Oct;35(10):714-23.
PubMed 18044379Beauchamp J, Caufield PW, Crall JJ, Donly K, Feigal R, Gooch B, Ismail A, Kohn W, Siegal M, Simonsen R; American Dental Association Council on Scientific Affairs. Evidence-based clinical recommendations for the use of pit-and-fissure sealants: a report of the American Dental Association Council on Scientific Affairs. J Am Dent Assoc. 2008 Mar;139(3):257-68. doi: 10.14219/jada.archive.2008.0155.
PubMed 18310730Straffon LH, Dennison JB, More FG. Three-year evaluation of sealant: effect of isolation on efficacy. J Am Dent Assoc. 1985 May;110(5):714-7. doi: 10.14219/jada.archive.1985.0425.
PubMed 3159777Primosch RE, Barr ES. Sealant use and placement techniques among pediatric dentists. J Am Dent Assoc. 2001 Oct;132(10):1442-51; quiz 1461. doi: 10.14219/jada.archive.2001.0061.
PubMed 11680361Collette J, Wilson S, Sullivan D. A study of the Isolite system during sealant placement: efficacy and patient acceptance. Pediatr Dent. 2010 Mar-Apr;32(2):146-50.
PubMed 20483019Alhareky MS, Mermelstein D, Finkelman M, Alhumaid J, Loo C. Efficiency and patient satisfaction with the Isolite system versus rubber dam for sealant placement in pediatric patients. Pediatr Dent. 2014 Sep-Oct;36(5):400-4.
PubMed 25303507Mattar RE, Sulimany AM, Binsaleh SS, Al-Majed IM. Comparison of Fissure Sealant Chair Time and Patients' Preference Using Three Different Isolation Techniques. Children (Basel). 2021 May 25;8(6):444. doi: 10.3390/children8060444.
PubMed 34070253Mattar RE, Sulimany AM, Binsaleh SS, Hamdan HM, Al-Majed IM. Evaluation of fissure sealant retention rates using Isolite in comparison with rubber dam and cotton roll isolation techniques: A randomized clinical trial. Int J Paediatr Dent. 2023 Jan;33(1):12-19. doi: 10.1111/ipd.13008. Epub 2022 May 22.
PubMed 35543302
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Trial Comparing Fissure Sealant Retention Rate, Chair Time, and Patients' Preference Using Dryshield and Cotton Roll Isolation
- ClinicalTrials.gov ID
- NCT05749991
- Acronym / sponsor ID
- VDR/EC/3344
- Conditions
- Retention, Time, Patient Preference
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Kuwait UniversityUniversity, hospital or other
- Study start
- 3 Jun 2018 (actual)
- Primary completion
- 9 Feb 2020 (actual)
- Study completion
- 25 Feb 2020 (actual)
- First posted
- 1 Mar 2023 (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 trial aimed to evaluate the sealant retention, patient's preference and chair time needed during pit and fissure sealant placement under two isolation techniques [Dryshield system (DS) and cotton roll isolation (CRI)] in a university setting.
Detailed description
In children, 80-90% of dental caries is found in the pits and fissures of the posterior permanent teeth. Pit and fissure sealants (PFS) can be used effectively to prevent dental caries. When applied correctly, dental PFS accomplish three main objectives: preventing dental caries development, hindering dental caries development in its initial phases, and inhibiting the spread of bacteria that cause dental caries. To be effective, PFS need to be applied under sufficient moisture control around the specific teeth undergoing treatment. Therefore, proper isolation of the teeth is one of the most important steps when placing sealants to ensure their retention.
Cotton roll isolation (CRI) has been widely used for sealant placement, and is the most common method among pediatric dentists. However, the placement of cotton rolls on the lateral part of the tongue or inadequate isolation during CRI has both been reported to produce gagging, tasting the contents and requiring frequent replacement of the wet cotton rolls.
A previous study demonstrated that new moisture control systems such as Isolite, produce sealant retention rates comparable to cotton roll isolation, while decreasing procedure time. DryShield (DS) has recently been introduced as an all-in-one isolation system. It is similar to the Isolite as it combines the tasks of fluid evacuation, tongue and cheek retraction, and serves as a bite block, but differs in that it is autoclavable and does not provide illumination. Its design allows it to suction and isolate half the oral cavity at a time. Therefore, it should presumably facilitate sealants placement under a more controlled environment, while reducing chair time for the dentist.
Few trials have compared the PFS chair time and patient acceptance of DS to the CRI. The goals of this study were to evaluate patients' preferences, time efficiency, and retention of PFS using DS compared to CRI in a single randomized clinical study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- All eligible study participants were randomised using simple block random allocation to ensure balanced randomization for each isolation system. Each participant was given an envelope and a printed participant number. Each number identified the isolation technique used for sealant placement and the isolation application sequence to be used.
| Arm | Type | Receives |
|---|---|---|
| DryShield Isolation | Experimental | Device: DryshieldDevice: Dryshield DryShield (DS) is an all-in-one isolation system. It combines the tasks of fluid evacuation, tongue and cheek retraction, and serves as a bite block. Its design allows it to suction and isolate half the oral cavity at a time. Dryshield was used to isolate teeth that required sealant placement in the assigned participants. |
| Cotton Roll Isolation | Active comparator | Device: Cotton roll isolationCotton Roll Isolation requires placing cotton rolls along the buccal mucosa, especially over the parotid glands ducts for maxillary teeth. For the mandibular teeth, the cotton rolls are placed in the buccal vestibule and the floor of the mouth (between the lower buccal mucosa and underneath and/or between the tongue). Cotton roll isolation was used to isolate teeth that required sealant placement in the assigned participants. With this technique, a high-speed evacuation of saliva and water is used. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Healthy patients with no compromising medical or physical condition
- age ranging from six to 12 years old;
- patients with at least one caries-free permanent molar in any quadrant, with normal anatomy, who qualified for pit and fissure sealant application with an International Caries Detection and Assessment System (ICDAS) score of 0-2.
- no prior sealants or restorations on the teeth under study;
- no cavitated carious lesions;
Key exclusion criteria (8 listed)
- a history of chronic disease (e.g., epilepsy, ectodermal dysplasia, cardiac anomalies);
- inability to return for follow-ups.
- patients with molars that have partially erupted
- a permanent molar with enamel flaws or abnormal anatomy
- children who are uncooperative, with a Frankl Behaviour Rating Scale of 1 or 2;
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 |
|---|---|---|
| DryshieldDryShield combines the tasks of high-suction evacuator, saliva ejector, bite block, tongue shield, and oral pathway protector in one easy-to-use device. The DryShield solution® is a patented autoclavable isolation system (MA, USA) | Device | DryShield Isolation |
| Cotton roll isolationAlso: Cotton rollCotton Roll Isolation requires placing cotton rolls along the buccal mucosa, especially over the parotid glands ducts for maxillary teeth. For the mandibular teeth, the cotton rolls are placed in the buccal vestibule and the floor of the mouth (between the lower buccal mucosa and underneath and/or between the tongue). With this technique, a high-speed evacuation of saliva and water is used. | Device | Cotton Roll Isolation |
Primary outcome
Change in Fissure Sealant Retention at 6 months
Time frame: Change in sealant retention at 6 months
Patients were clinically evaluated by a study supervisor as a blinded outcome assessor after 6 months of sealant placement. The evaluation was according to Simonsen's criteria: Completely retained, Partially retained, or Missing.
Change in Fissure Sealant Retention at 12 months
Time frame: Change in sealant retention at 12 months
Patients were clinically evaluated by a study supervisor as a blinded outcome assessor after 12 months of sealant placement. The evaluation was according to Simonsen's criteria: Completely retained, Partially retained, or Missing.
Change in Fissure Sealant Retention at 18 months
Time frame: Change in sealant retention at 18 months
assessor after 18 months of sealant placement. The evaluation was according to Simonsen's criteria: Completely retained, Partially retained, or Missing.
2 secondary outcomes
Placement time of sealants using Dryshield vs Cotton roll isolation
Time frame: 0 Day (After the completion of initial sealant placement and removal of the isolation device)
Patient preference for Dryshield or Cotton roll isolation
Time frame: 0 Day (After the completion of initial sealant placement and removal of the isolation device)
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 1 Mar 2023.
- Background: PubMed 28759120Ahovuo-Saloranta A, Forss H, Walsh T, Nordblad A, Makela M, Worthington HV. Pit and fissure sealants for preventing dental decay in permanent teeth. Cochrane Database Syst Rev. 2017 Jul 31;7(7):CD001830. doi: 10.1002/14651858.CD001830.pub5.
- Background: PubMed 18044379Jenson L, Budenz AW, Featherstone JD, Ramos-Gomez FJ, Spolsky VW, Young DA. Clinical protocols for caries management by risk assessment. J Calif Dent Assoc. 2007 Oct;35(10):714-23.
- Background: PubMed 18310730Beauchamp J, Caufield PW, Crall JJ, Donly K, Feigal R, Gooch B, Ismail A, Kohn W, Siegal M, Simonsen R; American Dental Association Council on Scientific Affairs. Evidence-based clinical recommendations for the use of pit-and-fissure sealants: a report of the American Dental Association Council on Scientific Affairs. J Am Dent Assoc. 2008 Mar;139(3):257-68. doi: 10.14219/jada.archive.2008.0155.
- Background: PubMed 3159777Straffon LH, Dennison JB, More FG. Three-year evaluation of sealant: effect of isolation on efficacy. J Am Dent Assoc. 1985 May;110(5):714-7. doi: 10.14219/jada.archive.1985.0425.
- Background: PubMed 11680361Primosch RE, Barr ES. Sealant use and placement techniques among pediatric dentists. J Am Dent Assoc. 2001 Oct;132(10):1442-51; quiz 1461. doi: 10.14219/jada.archive.2001.0061.
- Results publication: PubMed 20483019Collette J, Wilson S, Sullivan D. A study of the Isolite system during sealant placement: efficacy and patient acceptance. Pediatr Dent. 2010 Mar-Apr;32(2):146-50.
- Results publication: PubMed 25303507Alhareky MS, Mermelstein D, Finkelman M, Alhumaid J, Loo C. Efficiency and patient satisfaction with the Isolite system versus rubber dam for sealant placement in pediatric patients. Pediatr Dent. 2014 Sep-Oct;36(5):400-4.
- Results publication: PubMed 34070253Mattar RE, Sulimany AM, Binsaleh SS, Al-Majed IM. Comparison of Fissure Sealant Chair Time and Patients' Preference Using Three Different Isolation Techniques. Children (Basel). 2021 May 25;8(6):444. doi: 10.3390/children8060444.
- Results publication: PubMed 35543302Mattar RE, Sulimany AM, Binsaleh SS, Hamdan HM, Al-Majed IM. Evaluation of fissure sealant retention rates using Isolite in comparison with rubber dam and cotton roll isolation techniques: A randomized clinical trial. Int J Paediatr Dent. 2023 Jan;33(1):12-19. doi: 10.1111/ipd.13008. Epub 2022 May 22.
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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.
Abrar N Alanzi principal investigator
Kuwait University -Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dryshield and Cotton roll isolation in people with Retention and Time, run by Kuwait University at 1 site in Kuwait.
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 7 inclusion and 8 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 Mar 2023. 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 Kuwait. 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?
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?
Change in Fissure Sealant Retention at 6 months (time frame: Change in sealant retention at 6 months). The study lists 3 primary outcomes in all. 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 NCT05749991, which also lists 9 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 1 Mar 2023.