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FINAL REPORT

Clinical Evaluation of an LED Curing Light IVOCLAR VIVADENT, INC 175 Pineview Dr. Amherst, New York 14228

Principal Investigator: Carlos Mu単oz, DDS, MSD Professor and Chair University at Buffalo School of Dental Medicine Department of Restorative Dentistry

Submitted to: George W. Tysowski, DDS, MPH Vice President of Technology Ivoclar Vivadent Inc. 175 Pineview Dr. Amherst, NY 14228

Tom Hill, DDS, MS Manager, Applied Testing Center Ivoclar Vivadent Inc. 175 Pineview Dr. Amherst, NY 14228

Submitted by: Carlos Mu単oz, DDS, MSD Professor and Chair University at Buffalo School of Dental Medicine 215 Squire Hall 3435 Main Street Buffalo, NY 14214

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I. Purpose of Clinical Trial The purpose of this clinical trial was to evaluate the in-vivo performance of an LED curing light.

The primary objective of this study was to a) evaluate the post-operative sensitivity and soft tissue response and to b) evaluate the response of the gingival tissues to the curing light.

Study Design This was a multi-center, 2 month, non-randomized clinical study. The study involved 44 subjects for a total of 106 restorations. All 106 restorations were placed using the LED curing light (Blue Phase 16i).

The duration of the study per subject was 7 days. This included information collected prior to the restoration, one day follow-up (baseline), and a 7 day post-operative evaluation.

The research study sites used in this study were: a.) The State University of New York at Buffalo, School of Dental Medicine, 3435 Main Street, Buffalo, New York 14214 and b) East Amherst Dental Family Practice, 6161 Transit Road, East Amherst, NY 14221.

II. Pre-Study Visits, Protocol and Personnel Prior to the start of the study, Dr. Andreana made a visit to the UB School of Dental Medicine to demonstrate the proper use of the LED Curing Light. The protocol was also reviewed and any questions the research team or examiners had were answered. In addition, four Blue Phase LED Curing Lights were given to the Principal Investigator for use in this study.

The Research Personnel involved in this Clinical Study were: Carlos A. Mu単oz, DDS, MSD is Professor and Chair of the Department of Restorative Dentistry at the University at Buffalo, School of Dental Medicine. In this clinical trial, Dr. Mu単oz served as the Principal Investigator. His responsibilities included administration and supervision of all study activities as well as assuring accuracy in conduction of the study protocol guidelines, training of clinical examiners, submission of

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periodical study progress notes to the Sponsor and writing the final report.

Elaine Davis, PhD is an Associate Professor of Oral Diagnostic Sciences and Associate Dean for Student Affairs at the SUNY at Buffalo School of Dental Medicine. In this clinical trial, Dr. Davis was the Biostatistician.

She was consulted after the collection of data and contributed to the statistical analysis.

Jude Fabiano, DDS is the Director of the Advanced Education in General Dentistry Program and Associate Professor for the Department of Restorative Dentistry at the University at Buffalo. He was one of the clinical examiners for this clinical trial. His duties included gathering information during the initial screening such as assessing oral tissues, sensitivity, and dental health of the subject. He was also responsible for the same evaluations at the 7 day visit as well as the taking of digital photographs.

David Rice, DDS is a Clinical instructor for the Department of Restorative Dentistry at the University at Buffalo. Dr. Rice has also has a private practice office at the East Amherst Dental Family Practice for over ten years. In this clinical trial, Dr. Rice served as a clinical examiner. His responsibilities included taking a medical and dental history, performing a gingival index before and after the restoration was placed, and the taking of digital photos pre and post operatively. Dr. Rice also used the LED light while placing composite restorations on subjects.

Carla Beneduce, RDH, BA is Research Coordinator at the University at Buffalo, School of Dental Medicine. Her responsibilities included assisting the Principal Investigator in the administration and conduction of the study, entering data on CRFs, and the collection of data and materials from the satellite site. She also collected the digital photos and arranged them by subject number. An additional responsibility was to supervise the input of data to ensure accuracy.

Tabetha Magnuszewski, is a Research Assistant/Coordinator at the University at Buffalo, School of Dental Medicine. She performed tasks such as entering data in a database, maintaining subject’s files and writing a weekly report to be presented to the Principal Investigator.

III. Health Science Institutional Review Board (HSIRB) The University at Buffalo requires that all clinical investigations (involving testing of drugs, devices, invasive medical intervention and retrospective/prospective chart review on human subjects) receive 4

approval by the Health Science Institutional Review Board (HSIRB) prior to any subject’s contact, recruitment/enrollment and study advertisement.

Therefore, the Study documentation was sent to the Health Science Institutional Review Board (HSIRB) for approval on May 23, 2005. The Study protocol, additional documentation and the Informed Consent were approved on June 1, 2004.

Amendments Subsequently, due to the addition of personnel to the research team, amendments were made to the original HSIRB documentation. The first amendment was approved on June 6, 2005 and the second amendment was approved on June 24, 2005.

Informed Consent Prior to enrolling into the Study, each potential study candidate received the Informed Consent document, which the Principal Investigator or his designee also reviewed and explained to the subject to confirm that the study procedures as well as subject’s responsibilities were fully understood. Upon signing the Informed Consent document, each subject received a signed copy of the latter.

As mandated by the New York State Law and HSIRB local requirements, the Study was conducted in accordance with the ICH Guidelines for Good Clinical Practices (GCP).

IV. Subjects Enrollment and Recruitment The study population was recruited from the Western New York Area by one of two methods. At the State University of New York School of Dental Medicine recruitment was performed by indirect recruitment methods.

Approximately, 35% of responses came from school patients. At the East Amherst Dental Family Practice, recruitment occurred from their current patient population. Approximately 65 % of subjects were recruited in this way.

The first subject was enrolled on June 9, 2005 and the last subject was enrolled on July 20, 2005. During this period of time, 46 subjects were screened. Upon signing the Informed Consent, each subject was assigned a screening number starting from S0001 up to S0016 and from S0050 up to S0079.

Of these 46 subjects, 2 subjects were screening failures. Subject 0006 had an amalgam restoration placed instead of the originally planned composite.

Subject 0009 did not have any restorations placed at the screening visit and the subject was excluded from the from the study.

The remaining 44 subjects were scheduled for the 24 hour baseline data and 7 days post op visit. (Table1).

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Table 1. Subjects Enrollment by Gender

Screened

Screening Failures

Males

17

1

Females

29

1

Total

46

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As seen in Table 2, 100% of the subjects scheduled for completion, did successfully complete the study.

Table 2. Subject Completion by Gender

Successfully Screened

Completed

Males

16

16 (100%)

Females

28

28 (100%)

Total

44

44 (100%)

The age of each subject ranged from the youngest, 18 years of age, to the oldest, 81 years of age. The mean age of subjects from the study was 48.09 years of age. (Table 3)

Table 3. Subject Population by Age

Male Female

Oldest

Youngest

62

22

81 Mean Age 48.1 years old

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The restorations placed by the Blue Phase 16i LED Curing Light were categorized using Black’s classification for dental caries. Restorations that could be categorized further are also listed. (Table 4) 6

Table 4. Restorations Arranged by Procedure

Restoration Type Class I Class II Class III Class IV Class V Onlay (Appeal) Onlay (Concept) Splint Crown(s) (Appeal) 他 Crown Veneers Inlays Sealants

# Restorations Placed 13 24 4 4 16 1 10 3 4 3 24 0 0

Percentage of Restorations Placed (%) 12.3 22.6 3.8 3.8 15.1 1.0 9.4 2.8 3.8 2.8 22.6 0 0

Total Restorations Placed 106

V.

100.0%

Evaluation Methods and Results Gingival Index The gingiva surrounding each restored tooth was examined and scored using the Loe and Silness Gingival Index (GI). This measurement was taken from the Mesial, Buccal, Distal and Lingual aspect of each tooth.

The gingival index was recorded prior to the restoration being placed and again at the 7 day post-operative visit.

The results from the pre-operative gingival index are shown in Table 5.

Table 5. Gingival Index results at the Screening visit (%).

No Slight Moderate Severe Inflammation Inflammation Inflammation Inflammation Mesial Buccal Distal Lingual Total Surfaces

60 67 60 67

(56.6) (63.2) (56.6) (63.2)

254 (59.9%)

40 35 39 35

(37.7) (33.0) (36.8) (33.1)

149 (35.1%)

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4 2 5 2

(3.8) (1.9) (4.7) (1.9)

13 (3.1%)

2 2 2 2

(1.9) (1.9) (1.9) (1.9)

8 (1.9%)

The results from the gingival index taken at the 7 day visit are listed below in Table 6.

Table 6. Gingival Index Results at the 7 day visit (%).

Surface Mesial Buccal Distal Lingual Total Surfaces

No Slight Moderate Severe Inflammation Inflammation Inflammation Inflammation 84 (79.2) 21 (19.8) 1 (.9) 0 91 (85.9) 14 (13.2) 1 (.9) 0 84 (79.2) 21 (19.8) 1 (.9) 0 93 (87.7) 12 (11.3) 1 (.9) 0 352 (83.0%)

68(16.0%)

4 (0.9%)

0

The results from the Gingival Indices were compared by both tooth surface and by restoration. The results are seen in tables 7a and 7b.

Table 7a. Comparison of Gingival Index by Surface.

Surface Mesial Buccal Distal Lingual

No Change 75 73 73 71

Improved GI 28 28 30 30

Increased GI 3 5 3 5

Total

292 (68.9%)

116 (27.4%)

16 (3.8%)

Results clearly indicate that there was an improvement in the gingival index at the 7 day evaluation. There were 8 surfaces with severer inflammation at the gingival margin and after 7 days there were none.

Table 7b. Comparison of Gingival Index by Restoration.

Number of Restorations Percentage

No change

Improved GI

Increased GI

63 59.4%

38 35.9%

5 4.7%

Tooth Sensitivity Tooth sensitivity was measured using the Visual Analog Scale and/or subject interview. This was ascertained at the screening visit, 24 hour baseline, and at the 7 day follow-up visit. The sensitivity was scored from 0, no sensitivity, to 10, severe sensitivity. Sensitivity reported ranged from no sensitivity (0) to a sensitivity level of 6. No subjects reported sensitivity above 6 at any of the evaluations. (Table 8) 8

Table 8. Number of Restorations and Percent (%) Sensitivity Reported (screening, baseline, and 7 day follow-up).

Screening 24 hour (baseline) 7 day follow up

Sensitivity 0

Sensitivity 1

Sensitivity 2

Sensitivity 3

Sensitivity 4

Sensitivity 5

Sensitivity 6

87 (82.1) 103 (97.2) 104 (97.2)

1 (0.9) 3 (2.8) 1 (0.9)

6 (56.6) 0

11 (10.4) 0

0

0

0

0

1 (0.9) 0

1 (0.9)

0

0

0

0

The sensitivity was compared between visits and analyzed to determine a change, a decrease or an increase in sensitivity. (Table 9) Table 9. Comparison of Sensitivity (compared to screening data).

No Change 24 hour baseline 7 day follow-up

Decrease in Sensitivity 19 (17.9) 19 (17.9)

86 (81.1) 86 (81.1)

Increase in Sensitivity 1 (0.9) 1 (0.9)

Table 10 shows the comparison of restorations using both the data from the Gingival Index and the Visual Analog Scale and/or interviews. No data was collected that showed an increase in sensitivity and with no change in GI. Table 10. Comparison of GI and Sensitivity (compared to the screening data).

7 day followup % of Restorations

No Change

Improved Sensitivity No Change in GI

Improved Sensitivity Increase in GI

Increase in Sensitivity Improved GI

No Change in Sensitivity Improved GI

No Change in Sensitivity Increased GI

Improved changes in Sensitivity and GI

49

15

1

1

34

4

2

46.2

14.2

0.9

0.9

32.1

3.8

1.9

Digital Photographs Digital photographs were taken on subjects at the screening visit and at the 7 day follow up visit.

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The following are the photographs that were taken on subjects during this study. Examples of digital images are shown below. A large collection of images is attached to this report in a CD Subject: 0002

Pre placement

Post placement

Subject: 0008

Pre Placement

Post Placement

Subject: 0011

Pre Placement

7 day Follow-up

Pre Placement Dr. Rice

7 day Follow-up Dr. Rice 10

7 day Follow-up

VI. Adverse Reactions No adverse experiences were reported in this study VII.- Early Terminations No subjects were terminated from the study.

VIII.- Conclusions Within the limitations of this study, it is concluded that the use of the LED Blue Phase 16i is safe to use clinically at the indicated exposures times (5 and 10 seconds).

Jude Fabiano, DDS Clinical Instruction, Restorative Dentistry State University of New York at Buffalo

Date

David Rice, DDS Clinical Instruction, Restorative Dentistry State University of New York at Buffalo

Date

Tabetha Magnuszewski Clinical Research Coordinator, Restorative Department State University of New York at Buffalo

Date

Carlos Munoz, DDS, MSD Chair, Restorative Department State University of New York at Buffalo

Date

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