Efficacy and Retention of Sealants Placement Using Two Isolation Systems

Not Applicable

Completed

• Conditions: Time; Patient Preference; Retention
• Interventions: Device: Cotton roll isolation; Device: Dryshield

• Registration Number: NCT05749991
• Lead Sponsor: Kuwait University

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.

Study Timeline

• Study Start: 2018-06-03
• Primary Completion: 2020-02-09
• Study Completion: 2020-02-25
• Study First Submitted: 2023-01-23
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-19
• Last Update Submitted: 2023-02-19
• Study First Posted: 2023-03-01
• Last Update Posted: 2023-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cotton Roll Isolation	Cotton roll isolation	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.
DryShield Isolation	Dryshield	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.

Primary Outcome Measures

Name	Time	Method
Change in Fissure Sealant Retention at 6 months	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	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	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.

Secondary Outcome Measures

Name	Time	Method
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)	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.
Patient preference for Dryshield or Cotton roll isolation	0 Day (After the completion of initial sealant placement and removal of the isolation device)	A six-item interview-based questionnaire was administered to assess participants' acceptance of the isolation technique used.

Trial Locations

Locations (1)

Kuwait University Faculty of Dentistry Dental Clinics; 🇰🇼 Kuwait, Kuwait