2005D-0240
C 8
Volume 2

Comment

Tab 1 - H. Loe, and J. Silness (1963) ‘“Periodontal Disease in Pregnancy I, Prevalence and Severity”, Acta Odont Scand. 21: 533-551. Published Material

Tab 2 - J. Caton, A. Pobon, O. Bouwsma, T. Blieden, B. Frantz, M. Espeland (1988) “Associations Between Bleeding and Visual Signs of Interdental Gingival Inflammation”, J. Periodontol, 59: 722-727. Published Material

Tab 3 - J. Caton, O. Boouwsma, A. Polson and M, Espeland (1989) “Effects of Personal Oral Hygiene and Subgingival Scaling on Bleeding Interdental Gingiva”, J. Periodontol, 60: 84-90. Published Material

Tab 4 - G. Greenstein, J. Canton, A. M. Polson (1981) “Histologic Characteristics Associakd With Bleeding After Probing and Visual Signs of Inflammation”, J, Periodontol, 52: 420-425. Published Material

Tab 5 - H.G. Carter and G.P. Barnes (1974) “The Gingival Bleeding Index”, J. Periodontol: 45: 801-5. Published Material

Tab 6 - H.R. Muhlemann, and S. Son, (1971) “Gingival Sulcus Bleeding - A Leading Symptom in Initial Gingivitis”, Helvetica Odontologica Acta, 15: 105-113. Published Material

Tab 7 - R.S. Hirsch, N.G. Clark and G.C. Townsend (1981) “The Effect of Locally Released Oxygen on the Development of Plaque and Gingivitis in Man”, J. Clin. Periodontol, 8: 21-8 Published Material

Tab 8 - T. Engelberger, A. Hefti, A. Kallenberger, K.M. Rateitschak (1983) “Correlations Among Papilla Bleeding Index, Other Clinical Indices, and Histologically Determined Inflammation of Gingival Papilla”, J. Clin. Periodontol, 10: 579-589. Published Material

Tab 9 - P.G. Cooper, J. G. Caton, A.M. Poison (1983) “Cell Populations Associated with Gingival Bleeding”, J. Periodontol, 54: 497-502. Published Material

Tab 10 - R.C. Oliver, P. Helm-Pedersen, H Loe (1969) “The Correlation Between Clinical Scoring, Exudate Measurements and Microscopic Evaluation of Inflammation in the Gingiva”‘, J. Perio Res, 4: 13-21. Published Material

Tab 11 - S. W. Meitner, H. A. Zander, H. P. Iker, A. M. Poison (1979) “‘Identification of Inflamed Gingival Surfaces”, J Clin Periodontal, 6: 93-97. Published Material

Tab 12 - A. M. Poison and J. M. Goodson (1985) “Periodontal Diagnosis, Current Status and Future Needs”, J. Periodontol, 56: 25-34. Published Material

Tab 13 - G. Greenstein (1984) “The Role of Bleeding upon Probing in the Diagnosis of Periodontal Disease”, J. Periodontol, 55: 684-688. Published Material

Tab 14 - K.S. Kornman (1987) “Nature of Periodontal Diseases: Assessment.and Diagnosis“, J. Periodontol, 22: 192-204. Published Material

Tab 15 - S.F. McClanahan, R.D. B$z& A.R. Biesbroek (2001) “Identification and consequences of Distinct
Loe-Silness Gingival Index Examiner Styles for the Clinical Assessment of Giagiuitis’“, J. Periodontol, 72: 383-392. Published Material

Tab 16 - R. G. Marks, I. Magnussop, M. Taylor, B.. Clouser, J. Manmiak, W. B. Clark (1993) “Evaluation of
Reliability and Reproducibility of Dental Indices”, J. Clin Perio, 20, 54-58. Published Material

Tab 17 - Federal Register 68(103), May 29, 2003, at page 32237.

Tab 18 - Federal Register 68(103), May 29, 2003, at page 32286.

Tab 19 - CHPA/CTFA Antigingivitis Task Group November 25, 2003 comments.to FDA Docket No. 81N-033P, C 17, pages 15-22.

Tab 20 - C.H. Charles, KM. Mosteler, L.L. Bartels, and SM. Mankodi (2004) “Comparative Antiplaque and
Antigingivitis Effectiveness of a Chlorhexidine and an Essential Oil Mouthrinse: 6-month Clinical Trial”, J. Clin. Periodonol, 31: 878-884. Published Material

Tab 21 - Letter 56, Docket 81N-0033P

Tab 22 - R.R. Lobene, T. Weatherford, N.M. Ross, R.A. Lamm, L. Menaker (1986) ‘“A Modified Gingival Index for Use in Clinical Trials”, Clin. Prev. Dent, 8: 3-6. Published Material

Tab 23 - J.E. Mazza, M.G. Newmap, and T.N. Sims (1981) “Clinical and Antimicrobial Effect of Stannous Fluoride on Periodontitis”, J. Clin. Periodoatol, 8: 203-212. Published Material

Tab 24 - J. Ainamo and I. Bay (1975) “Problems and proposals for recording gingivitis and plaque”, Int. Dent. J, 25: 229-35. Published Material

Tab 25 - J.G. Caton and A.M.Polson (1985) ‘“The. Interdental Bleeding Index: A Simplified Procedure for Monitoring Gingival Health”, Comp. Cont. Edu. Dent, 6: 88-92. Published Material

Tab 26 - B. Bakdash (1995) “Current Patterns of Oral Hygiene Product use and Practices“, Periodontology 2000, 8: 11-14. Published Material

Tab 27 - K. Fox (2005) “ADA, J&J Join in Floss Campaign" Retrieved October 25, 2005 from ADA News
http://www.ada.org/prof/resources/pubs/adanews/adanewsarticle.asp?articleid=1277 Published Material

Tab 28 - A. A. Rizzo (1967) “Rabbit Corneal Irrigation as a Model System for Studies on the Relative Toxicity of Bacterial Products Implicated in Periodontal Disease. The Toxicity of Neutralized Ammonia Solutions”, J. Periodontol, 38, 491-499. Published Material

Tab 29 - S. E. Mergenhagen (1960),“Endotoxic Properties of Oral Bacteria as Revealed by the Local Shwartzman Reaction”, J. Dent. Res, 32, 267-272. Published Material

Tab 30 - T. Hofstad (1974) “Antibodies Reacting with Lipopolysaccharides from Bacteroides, Melaninogenicus, Bacteroides fragilis, and Fusobacterium nucleatum in Serum from Normal Human Subjects”, J. Infectious Diseases, 129, 349-352. Published Material

Tab 31 - T. E. VanDyke and W. B. Kinney (1989) “Biochemical Basis for Control of Plaque-Related Oral Diseases in the Normal and Compromised Host: Periodontol Diseases”, J. Dent. Res, 68, 1588-1596. Published Material

Tab 32 - S. Schultz-Haudt, M. A. Bruce and B. G. Bibby (1954) “Bacterial Factors in Nonspecific Gingivitis”, J. Dent. Res, 33, 454-458. Published Material

Tab 33 - P. Soder and G. Frostell (1966) “‘Proteolytic Activity of Dental Plaque Material. I. Action of Dental Plaque Material on Azocoll, Casein and Gelatin”, Acta Odant Scand, 24; 501-515. Published Material

Tab 34 - J. C. Thonard, C. M. Heftlin and A. I. Steinberg (1965) “Neuraminidase Activity in Mixed Culture Supernatant Fluids of Human Oral Bacteria”, J. Bacteriology, 89, 924-925. Published Material

Tab 35 - S. S. Socransky, M, Listgarten, C. Hubersak, J. Cotmore and A. Clark (1969) “Morphological and
Biochemical Differentiation of Three Types of Small Oral Spirochetes”, J. Bacteriology, 98, 878-882. Published Material

Tab 36 - W. J. Loesche and S. S. Socransky (1964) “Bacteriodes oralis, Proposed New Species Isolated from the Oral Cavity of Man”, J. Bacteriology, 88, 1329-1337. Published Material

Tab 37 - R. E. Montgomery, R. E. Singer, L. D, Ryan, D. W. Leedy, T. W. Keough, A, J. DeStefano (1982) “Relation Between Plaque Butyrate Productions and Reversal of Gingivitis”, J. Dent. Res, 61, 260. Published Material

Tab 38 - R. E. Singer and B. A. Buckner (1980) Characterization of Toxic Extracts of In Vitro Cultured Human Plaque”, J. Perio. Res, 15, 603-614. Published Material

Tab 39 - R. E. Singer and B. A. Buckner (1981) “Butyrate and Propionate: Important Components of Toxic
Dental Plaque Extracts”, Infec. Immun, 32, 458-463. Published Material

Tab 40 - D.J. White, E.R. Cox, N. Liang, D. Macksood, L. Bacca (1995) “A New Plaque Glycolysis and Regrowth Method (PGRM) for the In Viva Determination of Antimicrobial Deutifrice/Rinse Efficacy Towards the Inhibition of Plaque Growth and Metabolism-Method Development, Validation and Initial Activity Screens”, J. Clin. Dent, 6 Spec Iss; 59-70. Published Material

Tab 41 - C.J.L. Silwood, E. Lynch; A.W.D. Claxson, M.C. Grootveld (2002) "H-1 and C-13 NMR Spectroscopic Analysis of Human Saliva”, J. Dent. Res, 81: 422-427. Published Material

Tab 42 - H. Loe, E. Theilade and S.B. Jensen (1965) “Experiment Gingivitis in Man” J. Periodontol, 36: 177-187. Published Material

Tab 43 - E. Theilade, W.H. Wright, S. B. Jensen and H. Loe (1966), “Experimental Gingivitis in Man II. A Longitudinal Clinical and Bacterialogical Investigation”, J. Periodontol Res, 1: 1-13. Published Material

Tab 44 - Procter & Gamble’s comments to the ANPRM: November 23, 2003 comments to FDA Docket No. 81N-033P, C 14 pages 56-62.

Tab 45 - P. A. Sagel, P. G. Lapujade, J. M. Miller, R. J. Sunberg (2000) “Objective Quantification.of Plaque Using Digital Image Analysis”, Assesment of Oral Health, 130-143. Published Material

Tab 46 - Federal Register 70(180) September 19, 2005, pages 54945-54946, “Draft Guidance for Industry Acne Vulgaris: Developing Drugs: for Treatment”, retrieved September 25, 2005, from http://www.fda.gov/cder/guidance/6499dft.pdf

Tab 47 - F.N. Hyman, M.E. Welch, J.R. Cheever (1997) “Regulatory Issues for Evaluation of Therapies to
Prevent or Arrest Disease Progression”, Ann. Periodontal, 2: 166-179. Published Material

Tab 48 - P.B. Imrey, N.W. Chilton, B.L. Pihlstrom, H. M. Proskin, A. Kingman, M. A. Listgarten, S. O. Zimmerman, S. G. Ciancio, M. E. Colien, R. B. D’Agostino, S. L, Fischman, J. L. Ffeiss, X. C. Gunsolley, R. L. Kent, W. S. Killoy, L. L. Laster, R. G. Marks, and A. O. Varma, (1994) “‘Recommended Revisions to American Dental Association Guidelines for Acceptance of Chemotherapeutic Products for Gingivitis Control”, J. Periodontol, 29; 299-304. Published Material