Trials / Completed
CompletedNCT02995369
DryShield vs Cotton Roll Isolation During Sealants Placement: Efficiency and Patient Preference
DryShield vs Cotton Roll Isolation During Sealants Placement: Efficiency and Patient
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- Montefiore Medical Center · Academic / Other
- Sex
- All
- Age
- 5 Years – 14 Years
- Healthy volunteers
- Not accepted
Summary
The goals of this study are to determine if 1) placement times of pit and fissure sealants using the DryShield system differ from those when using the cotton roll isolation technique; and 2) there is a significant difference in patient preference between Dryshield and the cotton roll technique.
Detailed description
Pit and fissure caries account for 80 to 90 percent of all caries in permanent posterior teeth. Pit-and-fissure sealants can be used effectively to prevent caries. By micromechanically bonding to the teeth, they provide a physical barrier that keeps microorganisms and food particles from collecting in susceptible pits and fissures, thus preventing caries initiation and arresting caries progression. The effectiveness of sealants for caries prevention depends on long-term retention, which is largely a function of meticulousness of application: keeping the tooth surface free from saliva contamination during application and polymerization is critical. Low retention of sealants has been attributed to insufficient moisture control. 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. Although very effective, CRI can be a challenging technique especially when used in young children: the cotton rolls can be cumbersome for both the patient and the clinician. 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's 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. The goals of this study are to determine if 1) placement times of pit and fissure sealants using the DryShield system differ from those when using the cotton roll isolation technique; and 2) there is a significant difference in patient preference between DryShield and the cotton roll technique.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| OTHER | Cotton rolls | 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. |
Timeline
- Start date
- 2017-01-17
- Primary completion
- 2017-03-23
- Completion
- 2017-03-23
- First posted
- 2016-12-16
- Last updated
- 2023-01-20
- Results posted
- 2023-01-20
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02995369. Inclusion in this directory is not an endorsement.