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