Efficacy and Retention of Sealants Placement Using Two Isolation Systems

NCT05749991 | Completed

• 1 other identifier: VDR/EC/3344
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Retention; Time; Patient Preference

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Change in sealant retention at 18 months

Secondary Outcomes (2)

• Placement time of sealants using Dryshield vs Cotton roll isolation

  0 Day (After the completion of initial sealant placement and removal of the isolation device)

• Patient preference for Dryshield or Cotton roll isolation

  0 Day (After the completion of initial sealant placement and removal of the isolation device)

Study Arms (2)

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.

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.

Device: Cotton roll isolation

Interventions

Dryshield DEVICE

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)

DryShield Isolation

Cotton roll isolation DEVICE

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.

Also known as: Cotton roll

Cotton Roll Isolation

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kuwait University: lead

Study Sites (1)

Kuwait University Faculty of Dentistry Dental Clinics

Kuwait City, Kuwait

Location

Related Publications (9)

• 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.

  PMID: 28759120 BACKGROUND

• 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.

  PMID: 18044379 BACKGROUND

• 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.

  PMID: 18310730 BACKGROUND

• 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.

  PMID: 3159777 BACKGROUND

• 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.

  PMID: 11680361 BACKGROUND

• 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.

  PMID: 20483019 RESULT

• 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.

  PMID: 25303507 RESULT

• 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.

  PMID: 34070253 RESULT

• 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.

  PMID: 35543302 RESULT

MeSH Terms

Conditions

Patient Preference

Condition Hierarchy (Ancestors)

Patient Satisfaction; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Abrar N Alanzi

  Kuwait University -Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The participants, care providers and the principle supervisor were not blinded since they know which isolation technique was used during the placement of sealant. But the outcome assessor was blinded and he assessed the sealants placement after 6, 12, and 18 months.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 23, 2023
• First Posted: March 1, 2023
• Study Start: June 3, 2018
• Primary Completion: February 9, 2020
• Study Completion: February 25, 2020
• Last Updated: March 1, 2023

Record last verified: 2023-02

Locations

KU (1)