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4/02 Clinical Results for Thornton Periodontal Floss (THORNTON) and related topics

To: Dental Professionals, Patients, and other interested parties
From: Chairman Thomas Thornton

We have been receiving many favorable reports from dental professionals in the United States and abroad on the effectiveness of our Thornton Periodontal Floss ( hereinafter referred to as THORNTON. These dental professionals including Dentists, Hygienists, Periodontists, and others requested that we sponsor a clinical study to test and quantify the efficacy of THORNTON. We started work on such a study 18 months ago.

We were fortunate to have two Harvard trained clinical investigators manage the study at Columbia University , School of Dental and Oral Surgery, Division of Oral Biology.

Objective of Study
The primary purpose of this study was to evaluate the ability of Thornton Periodontal Floss (THORNTON) to remove interproximal plaque and improve gingival health.


Results

In a five week test period THORNTON was shown to significantly reduce gingival (gum) inflammation.

Gingival Index

Figure 1: Gingival Index

We at Thornton International notice the curve is trending lower with time which suggests even lower inflammation levels can be acheived with regular usage. To test this possibility we are sponsoring another study in Europe starting later this year. Results will be available in approximately two years. The Gingival Index above used Silness-Loe methodolgy which is considered to be "gold standard" in this field of study. We are also pleased to announce the The American Dental Association has allowed us to add the following statement to our 3in1 Floss. "Thornton 3in1 Floss is Accepted as an effective cleansing device which reduces gingivitis as part of a program for good oral hygiene to supplement the regular professional care required of oral health". Council on Scientific Affairs, ADA.

Plaque Index

Figure 2: Plaque Index

THORNTON demonstrated a significant decrease in plaque index over the five week study.

Gingival Crevicular Fluid Volume

Figure 3: Gingival Crevicular Fluid Volume

No significant change in GCF volume occurred over the study period. GCF volume did not correlate with clinical gingival inflammation as measured by the gingival index. The sampling methodology used, the limited scale of the Periotron, and the wide intersubject variations may have accounted for the findings.

Study Design

This is a single group split mouth longitudinal study design enrolling 29 systemically healthy adult subjects with minimal periodontal disease. All subjects had their maxillary Canines, first and second pre-molars and first maxillary molar teeth. All sites had probing depths of 5mm or less. Subjects received a thorough scaling root planing within two weeks prior to their entry into the study. At the baseline visit, all subjects were instructed on the use of Thornton Periodontal Floss. Each subject was their own control with one side of the maxilla using the Thornton Periodontal Floss. Each subject used Thornton Periodontal Floss once a day. The side using Thornton Periodontal Floss was determined randomly.

The subject's method and frequency of toothbrushing was not altered. Each patient was examined at baseline, one week, two weeks, three weeks, four weeks and five weeks. The examiner was blinded as to which side was Thornton Periodontal Floss. The examination consisted of: a) a measurement of gingival crevicular fluid (GCF) volume in a thirty second sample; b) a determination of gingival index (GI) (Silness-Loe); and c) plaque index (PI) (modified Quigley-Hein). Determinations were made at each of the following tooth surfaces on the maxilla: Mesial surface of the maxillary first molar, mesial and distal buccal aspect of the above tooth surfaces by a methylcellulose filter paper strip. Volume was determined on a calibrated Periotron 8000. For each time period, GCF volume, GI and PI from each site were averaged for each subject.

Summary
Thornton Periodontal Floss (THORNTON) was effective in removing dental plaque and improving gingival health in the interproximal areas.

 
THORNTON INTERNATIONAL INC.
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