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APPENDIX B. 5 PANEL ON DRUGS USED IN DENTISTRY a. Statement on the Use of Corticosteroids A good review article on the subject of corticosteroids in dentistry has been provided by Hendershot (3). He states: .. Corticosteroids are put to many uses in the treatment of disease; however, the only use which they appear to have in dentistry is in the control of inflammation. Thus, they have been used to reduce post-surgical swelling and to treat inflammatory conditions of the dental pulp, the periapical tissues, the oral mucous membranes and the temporomandibular joint. Unfortunately, however, there is a relative paucity of information on their uses in dentistry compared to the vast body of knowledge of their uses in med- icine." While several articles have reviewed the potential uses of corticosteroids in dentistry (1,4,11) it is germane to remember that the Panel must pro- vide opinions only with regard to those specific claims made by the companies marketing the products under consideration. Accordingly, some uses of the preparations which may require consideration in the future are not a matter of concern at the present time. Most of the preparations under consideration make a specific claim re- lated to dentistry, such as: "Conditions requiring dental surgery." This is followed by the instruction that in dental surgery the drug should be started several hours before the operation and continued for no more than two or three days postoperatively. It is difficult to decide what is meant by ''conditions requiring oral surgery." Review of the literature, however, revealed nine publications in which various corticosteroids were used in conjunction with surgical procedures: Miller (Strean) Hydrocortisone 11 Ross Hydrocortisone 8 Stewart Hydrocortisone 19 Spilka Prednisone 9 Freedman Prednisolone 2 Mead Triamcinolone 6 Ware Dexamethasone 12 Linenberg Dexamethasone 5 Nathanson Betamethasone 7 While the design of some of these studies leaves something to be desired, collectively they permit the conclusion that postoperative edema is · diminished in those patients who have had the benefit of parenteral corticosteroid therapy. The point has been made that these derivatives of cortisone differ mainly in their milligram potency; otherwise, their primary clinical 185
effects are similar. Once it has been shown that any given preparation is a systemically active corticosteroid, then it is logical to assume that it will share with all others a similar effect on oral tissues. The only point which remains, therefore, is to establish whether or not any corticosteroid, when administered systemically, provides benefit in the treatment of oral disease. In making a judgment on any given prep- aration, the evidence related to all others must be considered. This rationale has been the basis for the evaluations which follow. In the case of each preparation, an effort was made to identify publications which establish the drug as a systemically active steroid. In the pres- ence of such references, it then seemed appropriate to draw a conclusion relative to the usefulness of the drug in treating oral mucous membrane diseases. Such a conclusion reflects an awareness that oral diseases do respond to systemic corticosteroid treatment, even though evidence for this was not obtained on the basis of the drug in question. DOCUMENTATION: 1. Douglas, B.L., and H. Kresburg. Cortisone in dentistry. Oral Surg. 9:978-984, 1956. 2. Freedman, S.D. Combination of prednisolone and vitamin therapy in the control of postoperative edema. J. Oral Surg. 18:332-335, 1960. 3. Hendershot, L.C. The use of adrenocorticosteroid hormones in dentistry. Dent. Clinics of North Amer. 503-512, 1963. 4. Kiryati, A.A. The present status of the adrenal cortical hormones as therapeutic agents in oral conditions. Dent. Clinics of North Amer. 217-229, 1958. 5. Linenberg, W.B. The clinical evaluation of dexamethasone in oral surgery. Oral Surg. 20:6-28, 1965. 6. Mead, S.V. Triamcinolone given orally to control postoperative reactions to oral surgery. J. Oral Surg. 22:484-487, 1964. 7. Nathanson, N.R., and D.M. Seifert. Betamethasone in dentistry; a clinical report. Oral Surg. 18:715-721, 1964. 8 Ross, R., and C.P. White. Evaluation of hydrocortisone in prevention of postoperative complications after oral surgery: a preliminary report. J. Oral Surg. 16:220-226, 1958. 9. Spilka, C.J. The place of corticosteroids and antihistamines in oral surgery. Oral Surg. 14:1034-1042, 1961. 10. Stewart, G.G. The antihistamines and corticosteroids in the reduction of postoperative sequelae following endodontic surgery. Oral ·surg. 9:216-220, 1965. 11. Strean, L.P. Cortisone in dentistry. Dental Items of Interest Pub. Co., Brooklyn, 1957, p. 178. 12. Strean, L.P., and C.P. Horton. Hydrocortisone in dental practice. Dental Digest 59:8-16, 1953. 13. Ware, W.H., J.C. Campbell, and R.C. Taylor. Effect of a steroid on postoperative swelling and trismus. Dent. Progress 3:116-120, 1963. 186
b. Statement on the Use of Mouthwashes The American Dental Association's Council on Dental Therapeutics has classified all medicated mouthwashes in Group D continuously for 17 years.1~2 Classification in Group D means that the products do not meet the accept- ance standards outlined by the Council on Dental Therapeutics. The stand- ards include requirements such as the avoidance of misleading names, the presentation of evidence for usefulness and safety ("objective data from clinical and laboratory studies") and the use of clear and accurate label- ing and ·a dvertising. The Council "does not presently recognize any sub- stantial contribution to the oral health in the unsupervised use of medi- cated mouthwashes by the general public. The need for a truly therapeutic mouthwash and the degree of its usefulness must be ascertained by a dentist or physician. Claims that medicinal agents may be used in the home to re- lieve pain or other symptoms of oral disease are contrary to the public interest, since such use may delay patients from seeking professional care for the underlying disease." l Many medicated mouthwashes claim efficacy because the active ingre- dients reduce the concentration of total oral bacteria. The advantage of a simple reduction in numbers of oral bacteria is dubious "in view of the fact that under normal conditions the oral cavity harbors a prolific and variegated flora which exerts no apparent harmful effect on the gen- eral health of the individual â¢â¢â¢â¢ " 3 Also, undesirable effects, such as upsetting normal oral flora, are inherent in the prolonged use of a germicidal mouthwash which has specific antibacterial activity as opposed to broad antibacterial activity. There is no convincing evidence that any medicated mouthwash, used as a part of a daily hygiene regimen, has therapeutic advantage over a physiologic saline solution or even water. Furthermore, if mouthwashes were shown to be effective germicides, no documented evidence has been supplied to indicate that specific oral infectious diseases have been affected by use of the mouthwash. We agree that the need for a medicated mouthwash should and must be ascertained by a dentist or physician. Regardless of whether the pro- ducts are efficacious as germicides in the mouth, the desirability of permitting these products to be sold directly to the public is questionable. Thus, a mouthwash should not be relied upon to decrease or mask per- sistent mouth odors, rather, the cause of the persistent odor should be fully investigated by a practitioner. Claims that mouthwashes overcome mouth odors should be viewed with considerable reserve, for breath odors may result from any combination of local and systemic diseases or mal- functions. 187
The Panel on Drugs Used in Dentistry, therefore, believes that "over the counter" mouthwashes should be required to delete therapeutic claims for breath odor, relief of throat pain, and therapeutic reduction of oral bacteria. Mouthwashes should be allowed on the market only as pleasantly flavored solutions but without advertising as to therapeutic value. DOCUMENTATION: 1. American Dental Association. Dentifrices and mouthwashes, p. 217. In Accepted Dental Remedies-1967. (32nd ed.) Chicago: American Dental Association, 1966. 2. Council on Dental Therapeutics. Council announces classification of additional products. J. Amer. Dent. Assoc. 41:501-502, 1950. (Report) 3. Council on Dental Therapeutics. Council reports on detergents con- taining hexachlorophene. J. Amer. Dent. Assoc. 43:604-606, 1951. 4. Doty, J.R. Mouthwashes: the dental viewpoint. Today's Health 40: 6-7, 1962. 5. Ostrolenk, M., and W. Weiss. The effect of mouthwashes on the oral flora. J. Amer. Pharm. Assoc. (Scientific Edition) 48:219-221, 1959. 188
