Dental Caries in Children, Dental Caries on Pit and Fissure Surface, Dental Leakage
Conditions
Brief summary
The purpose of this study is to evaluate and compare the clinical retention of bonded fissure sealants placed under rubber dam isolation and cotton roll isolation.
Interventions
DEVICERubber Dam Set
Rubber dam set is the generic name of an isolation device that consists of a rubber sheet that isolates the tooth from saliva, a clamp to hold the rubber sheet on the tooth to be isolated, and a metal frame to keep the rubber sheet in a stretched position during dental procedures.
DEVICEDental Cotton Roll
Cotton roll is the generic name of a disposable isolation device made of cotton in a cylindrical form. Cotton rolls are used to isolate the teeth from saliva, by being placed in the cheek and tongue during placement of sealants or filings.
Sponsors
Zafer Cavit Cehreli, DDS, PhD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
6 Years to 16 Years
Healthy volunteers
Yes
Inclusion criteria
* Teeth having a clinical indication of sealing with bonded resin pit and fissure sealants * Patients with four fully-erupted permanent molars, with unstained, caries-free and unsealed pit and fissures
Exclusion criteria
* Patients having incipient carious lesions, fewer erupted molars or teeth without pits on buccal/palatal surfaces. * Patients with systemic diseases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The US Public Health Service criteria for retention of sealants | 12 months | Alpha: No Loss of sealant, Bravo: Partial Loss of Sealant, Charlie: Total loss of sealant |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The US Public Health Service criteria for secondary caries on sealants | 12 months | Alpha: Charlie: There is no clinical diagnosis of caries. Charlie: There is clinical diagnosis of caries |
Countries
United States
Outcome results
None listed