A LONGITUDINAL STUDY ASSESSING THE CLINICAL PERFORMANCEOF A NEW PIT AND FISSURE SEALANT MATERIAL:EMBRACE WETBOND(TWO-YEAR REPORT, MAY 2005)

Joseph P. O’Donnell, D.M.D., M.S.
Associate Clinical Professor
Tufts University School of Dental Medicine

As stated in previous reports, a clinical study begun in May 2002 is being conducted to test the effectiveness of a new pit and fissure sealant material (Embrace Wetbond Pit and Fissure Sealant, Pulpdent Corporation, Watertown, Massachusetts USA). This study is strictly evidence-based and is being conducted within a suburban pediatric dental practice that has two office locations.

No patient has been excluded from this study due to patient behavior or other risk factors. Three board certified pediatric dentists and a fourth pediatric dentist who is progressing toward board certification are the clinicians involved in placing and evaluating the sealants. All four pediatric dentists are employing the same clinical technique in preparing the teeth and applying Embrace. This technique is described in detail in the "Methods" section of this Report.

The data reported below represents data collected over a period of almost three years, and all teeth in this report have been sealed for a minimum of two years. In total the pediatric dental practice conducting this study places approximately six thousand sealants per year. Thus, over a period of time the opportunity exists to provide meaningful information about the clinical performance of this sealant material from a very large patient population.

METHODS
Primary and permanent posterior teeth were selected for use in this study provided they were non-carious and unrestored. The teeth received a pumice prophylaxis and were rinsed and dried. The teeth were isolated with cotton rolls and/or dri-angles to prevent salivary contamination. A 38% phosphoric acid etching gel was applied to the enamel surface for 15 seconds. The teeth were then rinsed with copious water to remove all etching gel. After rinsing, the teeth were lightly dried to remove excess water but were not desiccated. The teeth did not appear frosty white as in traditional sealant techniques. Rather, the occlusal surface of the teeth remained slightly moist and appeared glossy and shiny prior to application of the sealant material.

Embrace Pit and Fissure Sealant was applied to the pits and fissures using a small applicator tip supplied by the manufacturer and attached to the syringe or by means of a small ball burnisher that was dipped into a light-protected well into which an appropriate amount of Embrace sealant had been dispensed. Embrace Pit and Fissure Sealant was spread over the occlusal surface so that all pits and fissures were covered. The sealant was then light-cured for 20 seconds using a halogen curing light (3M XL 2500 Curing Light). After curing, the teeth were checked with an explorer to ensure that all margins were sealed and that no air bubbles existed. Articulating paper was used to check occlusion and any premature contacts were adjusted.

STUDY SAMPLE
The study sample included children who presented for routine six-month preventive visits. In order to be included in this study the patients must have had at least one primary or permanent

molar sealed with Embrace Pit and Fissure Sealant for a period of at least two years. Any patient who met these criteria was included in the study regardless of age, patient cooperation or difficulty of isolation of teeth during sealant placement. During this data collection period a total of 1102 teeth were evaluated. These teeth were evaluated according to the criteria described in the Preliminary Report:

A sealant evaluation form was completed by the dental hygienist indicating the date the sealants were placed and the date of the evaluation. The pediatric dentist conducting the evaluation may not have been the operator who placed the sealant. In addition to clinical inspection and use of a sharp dental explorer, bite-wing radiographs, if taken as part of the preventive visit, were utilized to determine the presence of caries in the sealed teeth.

RESULTS
Of the 1102 teeth evaluated in this two-year study, none of the teeth evaluated had developed occlusal caries during the two-year period. 1047 remained intact with good marginal integrity. Fifty-five of the teeth evaluated had the sealant repaired or replaced at some time during the two-year period. Therefore, ninety-five percent (95%) remained in the same condition as when they were originally placed, and one hundred percent (100%) were caries-free on the sealed occlusal surfaces. This information was determined by reviewing the dental record of each patient.

DISCUSSION
These two-year results are very consistent with previous reports on the clinical success of Embrace WetBond as a pit and fissure sealant material. There are many factors that can contribute to the failure of a sealant. Among these are the child's cooperation, stage of eruption, difficulties in access and isolation of the tooth during placement of the sealant, oral hygiene habits, and presence of a diet high in sugars and hard or sticky substances. In this evidence-based, longitudinal study, none of these factors were sorted out to create a controlled sample that would strictly evaluate the ability of Embrace to remain bonded to the tooth during normal masticatory function. Instead, this study evaluated over 1100 teeth that were sealed in a typical pediatric dental practice, were subject to a wide range of stresses and factors that was out of the control of the evaluators, and, ultimately, measured success or failure in simple terms: was the sealant intact and providing protection to the tooth or did it have to be replaced?

These results indicate that Embrace WetBond Pit and Fissure Sealant is an excellent choice as a pit and fissure sealant. It is often difficult to maintain a dry field, especially when treating children, and the fact that the material works well in a slightly moist field is a great benefit to the practitioner. The ability to bond in the presence of moisture simplifies the sealant procedure and is less technique sensitive. This may be one of the reasons for the excellent results. Also, the evaluators noted that after curing the sealant the margins were virtually undetectable. This marginal seal may explain the elimination of marginal leakage that has been reported in other studies on Embrace WetBond Pit and Fissure Sealant.