Clinical trial NCT05749991: Efficacy and Retention of Sealants Placement Using Two Isolation Systems
Official title: A Randomized Controlled Clinical Trial Comparing Fissure Sealant Retention Rate, Chair Time, and Patients' Preference Using Dryshield and Cotton Roll Isolation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retention
Time
Patient Preference
Lead sponsor: Kuwait University
Sponsor class: OTHER
First posted: 2023-03-01
Enrollment: 65
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Healthy patients with no compromising medical or physical condition
2. age ranging from six to 12 years old;
3. 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.
4. no prior sealants or restorations on the teeth under study;
5. no cavitated carious lesions;
6. cooperative patients (classified as 3 or 4 according to the Frankl Behavioral Rating Scale)
7. legal guardian consents and approved assents to the child's participation in the study.

Exclusion Criteria:

1. a history of chronic disease (e.g., epilepsy, ectodermal dysplasia, cardiac anomalies);
2. inability to return for follow-ups.
3. patients with molars that have partially erupted
4. a permanent molar with enamel flaws or abnormal anatomy
5. children who are uncooperative, with a Frankl Behaviour Rating Scale of 1 or 2;
6. children who have a severe gagging reflex;
7. special needs children.
8. Those who do not provide appropriate assents or consents

Primary outcomes:
measure: Change in Fissure Sealant Retention at 6 months
timeFrame: Change in sealant retention at 6 months
measure: Change in Fissure Sealant Retention at 12 months
timeFrame: Change in sealant retention at 12 months
measure: Change in Fissure Sealant Retention at 18 months
timeFrame: Change in sealant retention at 18 months
Secondary outcomes:
measure: Placement time of sealants using Dryshield vs Cotton roll isolation
timeFrame: 0 Day (After the completion of initial sealant placement and removal of the isolation device)
measure: Patient preference for Dryshield or Cotton roll isolation
timeFrame: 0 Day (After the completion of initial sealant placement and removal of the isolation device)
Other outcomes:
Locations:
city: Kuwait
country: Kuwait
facility: Kuwait University Faculty of Dentistry Dental Clinics
Study officials:
affiliation: Kuwait University -Faculty of Dentistry
name: Abrar N Alanzi
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Jenson 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.
citation: Beauchamp 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.
citation: Straffon 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.
citation: Primosch 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.
citation: Collette 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.
citation: Alhareky 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.
citation: Mattar 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.
citation: Mattar 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.