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Current status of electric toothbrushes
Current status of electric toothbrushes
COUNCIL ON DENTAL THERAPEUTICS
Within the past several years numerous brands of electrically powered tooth brushes have been introduced for sale in the United States and actively promoted both to the dental profession and to the public. Some information from marketing agencies indicates that there have been or may be as many as 75 brands of these powered devices marketed in this coun try. The powered toothbrushes that have appeared on the market have varied widely in their operating characteristics, their construction, their cost and their potential hazard either from electrical shock or from the possibility of trauma tizing the oral tissues. One device was the subject of a seizure action by the Food and Drug Administration as a result of failure to include an adequate warning statement in the labeling.1 The competitive promotion of some of these devices has at times displayed a tendency toward exaggerated claims and unwarranted disparagement of the con ventional manual toothbrush.2 There has also been a wide variation in the charac
ter and amount of clinical testing to which the several devices have been sub jected. All of these considerations empha size the need for a continuing objective evaluation of the evidence to support the claims for improved oral hygiene that are attributed to individual devices. In an ticipation of this need, the Association’s House of Delegates has authorized the Council on Dental Therapeutics to in clude powered toothbrushes in its evalua tion program in order to provide authori tative information to the dental profession and general guidance and protection to the public. This program is designed also to encourage the responsible firms to es tablish adequate testing programs and to promote their products in a way that will contribute to the oral health of the public. Since the powered toothbrushes are marketed directly to the consumer by over-the-counter sale, it is probable that the larger number of brushes are pur chased on the basis of consumer judg ment and are used without professional instruction. These devices should there
REPORTS O F C O U N C IL S A N D BUREAUS
fore be capable of being employed with safety by the majority of persons under all general or reasonable conditions of unsupervised use. This would include per sons with wide variations in skill and discrimination and with wide differences in the state of their oral health. Special types of brushes that may involve greater potential hazard to the oral structures should be labeled and promoted in a manner designed to limit their distribu tion to recommendation or prescription by the profession. Several types of brushing motions are employed in the marketed forms of elec tric toothbrushes. The motions include: ( 1) the arcuate or up-and-down movement in a direction generally per pendicular to the long axis of the handle, (2 ) the reciprocating or back-andforth movement in the same direction as the long axis of the handle, (3) a combination of an up-anddown and a reciprocating motion, and (4) a rotating motion. Some advertisements have claimed a superiority for one type of motion or im plied a close similarity of one motion to that involved in a procedure for manual brushing as described for general use in dental health educational material issued by the American Dental Association. It may be noted that the manual procedure is not duplicated in all details by the ac tion of any of the powered brushes. It may be noted further that in the course of directing the bristles to the various sur faces of the teeth in different parts of the dental arches, the bristle surface will move in a variety of directions with re spect to the teeth. In fact, the operator may to a considerable degree purposely control the direction of the brush surface by holding the brush handle in selected positions. It is desirable in its operation that the device produce maximum cleaning of the teeth without undue abrasion of teeth or restorations and with minimal trauma to the soft tissues. In order to fulfill these
. V O LU M E 69, SEPTEMBER 1964 • 151/405
requirements to a satisfactory degree, it is essential that the motor unit develop ade quate power but that the device possess a self-limiting action on soft tissues. The latter seems more likely to be achieved primarily by a combination of appropri ate speed, appropriate bristle characteris tics and a limited magnitude of the arc or stroke of the brush head. When observed through the medium of slow-motion pho tography or by direct visualization with a stroboscope, it is noted that under a constant pressure the tips of the bristles travel more freely on a hard surface as of the teeth than on a softer surface such as the gingival mucosa. Thus in some devices at a given pressure the bristle tips may exhibit a definite excursion on the teeth surfaces whereas the tips contacting the soft tissues may appear stationary or in a slight vibratory motion. A variety of laboratory and clinical tests may be re quired in the development of a powered brush in order to insure a design that will provide suitable operating characteristics. The Council, however, will place special emphasis on the results of clinical inves tigations since it is concerned primarily with the performance of the marketed de vice under the various conditions of use. Judgment will be based upon both quality and quantity of evidence. The studies should include objective comparative ob servations on a large number of subjects or patients who range widely in age, manipulative skill, knowledge of brushing procedures, oral health status and in other pertinent factors. Very special care is re quired in clinical trials designed to deline ate the role of these devices as physio therapeutic agents for the treatment of preexisting oral diseases. Toothbrushing may often be employed primarily for cosmetic purposes but there is a general recognition by the dental pro fession of the important contribution which the cleaning action of proper toothbrushing makes to oral hygiene. This con cept is supported by general clinical ob servations and by specific study.3 It has also been reported recently that . . the
152/406 • THE J O U R N A L OF THE A M E R IC A N DENTAL A S S O C IA T IO N
correlation of increasing oral uncleanli ness and age with the increasing preva lence and severity of periodontitis is clearly and overwhelmingly predomi nant.” 4 In contrast to the general recognition of its value for cleaning and associated benefits, the further values attributed to the toothbrush as a physiotherapeutic de vice are still the subject of controversy. Until there is evidence available to resolve this controversy, it is the opinion of the Council that promotional claims for toothbrushes (either manual or powered) should be limited to those of a cosmetic nature and to those associated with oral cleanliness as an aid in the prevention of some forms of periodontal disease. This should not be interpreted to preclude the possibility that further benefits may be demonstrated by carefully designed and executed clinical trials. It is the further opinion of the Council that, in any case, consumer advertising should not include claims relating to the treatment of exist ing oral disease because of the potential for harm if the device were used for this purpose without professional supervision. It is recognized that a conventional toothbrush in the hands of an individual who is reasonably adept and informed in its use can be employed with sufficient diligence to produce an adequate cleans ing effect. It is further recognized, how ever, that there are many physically hand icapped individuals and others who are not skillful in the use of a manual brush. If a powered brush can be shown to be a superior cleansing device when used by these persons, it will be regarded as hav
ing a potential usefulness beyond that of the conventional brush. In its présent evaluation of powered toothbrushes, the Council on Dental Therapeutics will apply the pertinent sec tions of the General Provisions for the Acceptance of Products as well as the following additional standards: (1) As evidence of technical safety, the device must have been submitted to examination by and meet the require ments of an appropriate testing laboratory such as listing by Underwriters’ Labora tories, Inc. This requirement may be waived for devices operating from nonrechargeable batteries of low voltage. (2) Adequate evidence must be avail able from clinical investigations to show that unsupervised use of the device will not be harmful to oral hard or soft tissues or restorations. (3) Adequate evidence must be pro vided from clinical tests to show that the device can be readily employed under unsupervised conditions by the larger seg ment of the public to provide a high de gree of oral cleanliness. (4) Claims for the device in labeling and in advertising to the public shall be limited to those related to oral cleanliness and the advertising shall avoid unwar ranted disparagement of the conventional toothbrush. I. Food and Drug Administration. News release, May 14, 1962. ' 2. Council on Dental Therapeutics. Manual brushes not obsolete. JA D A 68:279 Feb. 1964. 3. Hine, M. K. Use of the toothbrush in the treat ment of periodontitis. JA D A 41:158 Aug. 1950. 4. Scherp, Henry W. Current concepts in periodontal disease research: epidemiological contributions. JADA 68:667 May 1964.
COUNCIL ON DENTAL THERAPEUTICS
Within the past several years numerous brands of electrically powered tooth brushes have been introduced for sale in the United States and actively promoted both to the dental profession and to the public. Some information from marketing agencies indicates that there have been or may be as many as 75 brands of these powered devices marketed in this coun try. The powered toothbrushes that have appeared on the market have varied widely in their operating characteristics, their construction, their cost and their potential hazard either from electrical shock or from the possibility of trauma tizing the oral tissues. One device was the subject of a seizure action by the Food and Drug Administration as a result of failure to include an adequate warning statement in the labeling.1 The competitive promotion of some of these devices has at times displayed a tendency toward exaggerated claims and unwarranted disparagement of the con ventional manual toothbrush.2 There has also been a wide variation in the charac
ter and amount of clinical testing to which the several devices have been sub jected. All of these considerations empha size the need for a continuing objective evaluation of the evidence to support the claims for improved oral hygiene that are attributed to individual devices. In an ticipation of this need, the Association’s House of Delegates has authorized the Council on Dental Therapeutics to in clude powered toothbrushes in its evalua tion program in order to provide authori tative information to the dental profession and general guidance and protection to the public. This program is designed also to encourage the responsible firms to es tablish adequate testing programs and to promote their products in a way that will contribute to the oral health of the public. Since the powered toothbrushes are marketed directly to the consumer by over-the-counter sale, it is probable that the larger number of brushes are pur chased on the basis of consumer judg ment and are used without professional instruction. These devices should there
REPORTS O F C O U N C IL S A N D BUREAUS
fore be capable of being employed with safety by the majority of persons under all general or reasonable conditions of unsupervised use. This would include per sons with wide variations in skill and discrimination and with wide differences in the state of their oral health. Special types of brushes that may involve greater potential hazard to the oral structures should be labeled and promoted in a manner designed to limit their distribu tion to recommendation or prescription by the profession. Several types of brushing motions are employed in the marketed forms of elec tric toothbrushes. The motions include: ( 1) the arcuate or up-and-down movement in a direction generally per pendicular to the long axis of the handle, (2 ) the reciprocating or back-andforth movement in the same direction as the long axis of the handle, (3) a combination of an up-anddown and a reciprocating motion, and (4) a rotating motion. Some advertisements have claimed a superiority for one type of motion or im plied a close similarity of one motion to that involved in a procedure for manual brushing as described for general use in dental health educational material issued by the American Dental Association. It may be noted that the manual procedure is not duplicated in all details by the ac tion of any of the powered brushes. It may be noted further that in the course of directing the bristles to the various sur faces of the teeth in different parts of the dental arches, the bristle surface will move in a variety of directions with re spect to the teeth. In fact, the operator may to a considerable degree purposely control the direction of the brush surface by holding the brush handle in selected positions. It is desirable in its operation that the device produce maximum cleaning of the teeth without undue abrasion of teeth or restorations and with minimal trauma to the soft tissues. In order to fulfill these
. V O LU M E 69, SEPTEMBER 1964 • 151/405
requirements to a satisfactory degree, it is essential that the motor unit develop ade quate power but that the device possess a self-limiting action on soft tissues. The latter seems more likely to be achieved primarily by a combination of appropri ate speed, appropriate bristle characteris tics and a limited magnitude of the arc or stroke of the brush head. When observed through the medium of slow-motion pho tography or by direct visualization with a stroboscope, it is noted that under a constant pressure the tips of the bristles travel more freely on a hard surface as of the teeth than on a softer surface such as the gingival mucosa. Thus in some devices at a given pressure the bristle tips may exhibit a definite excursion on the teeth surfaces whereas the tips contacting the soft tissues may appear stationary or in a slight vibratory motion. A variety of laboratory and clinical tests may be re quired in the development of a powered brush in order to insure a design that will provide suitable operating characteristics. The Council, however, will place special emphasis on the results of clinical inves tigations since it is concerned primarily with the performance of the marketed de vice under the various conditions of use. Judgment will be based upon both quality and quantity of evidence. The studies should include objective comparative ob servations on a large number of subjects or patients who range widely in age, manipulative skill, knowledge of brushing procedures, oral health status and in other pertinent factors. Very special care is re quired in clinical trials designed to deline ate the role of these devices as physio therapeutic agents for the treatment of preexisting oral diseases. Toothbrushing may often be employed primarily for cosmetic purposes but there is a general recognition by the dental pro fession of the important contribution which the cleaning action of proper toothbrushing makes to oral hygiene. This con cept is supported by general clinical ob servations and by specific study.3 It has also been reported recently that . . the
152/406 • THE J O U R N A L OF THE A M E R IC A N DENTAL A S S O C IA T IO N
correlation of increasing oral uncleanli ness and age with the increasing preva lence and severity of periodontitis is clearly and overwhelmingly predomi nant.” 4 In contrast to the general recognition of its value for cleaning and associated benefits, the further values attributed to the toothbrush as a physiotherapeutic de vice are still the subject of controversy. Until there is evidence available to resolve this controversy, it is the opinion of the Council that promotional claims for toothbrushes (either manual or powered) should be limited to those of a cosmetic nature and to those associated with oral cleanliness as an aid in the prevention of some forms of periodontal disease. This should not be interpreted to preclude the possibility that further benefits may be demonstrated by carefully designed and executed clinical trials. It is the further opinion of the Council that, in any case, consumer advertising should not include claims relating to the treatment of exist ing oral disease because of the potential for harm if the device were used for this purpose without professional supervision. It is recognized that a conventional toothbrush in the hands of an individual who is reasonably adept and informed in its use can be employed with sufficient diligence to produce an adequate cleans ing effect. It is further recognized, how ever, that there are many physically hand icapped individuals and others who are not skillful in the use of a manual brush. If a powered brush can be shown to be a superior cleansing device when used by these persons, it will be regarded as hav
ing a potential usefulness beyond that of the conventional brush. In its présent evaluation of powered toothbrushes, the Council on Dental Therapeutics will apply the pertinent sec tions of the General Provisions for the Acceptance of Products as well as the following additional standards: (1) As evidence of technical safety, the device must have been submitted to examination by and meet the require ments of an appropriate testing laboratory such as listing by Underwriters’ Labora tories, Inc. This requirement may be waived for devices operating from nonrechargeable batteries of low voltage. (2) Adequate evidence must be avail able from clinical investigations to show that unsupervised use of the device will not be harmful to oral hard or soft tissues or restorations. (3) Adequate evidence must be pro vided from clinical tests to show that the device can be readily employed under unsupervised conditions by the larger seg ment of the public to provide a high de gree of oral cleanliness. (4) Claims for the device in labeling and in advertising to the public shall be limited to those related to oral cleanliness and the advertising shall avoid unwar ranted disparagement of the conventional toothbrush. I. Food and Drug Administration. News release, May 14, 1962. ' 2. Council on Dental Therapeutics. Manual brushes not obsolete. JA D A 68:279 Feb. 1964. 3. Hine, M. K. Use of the toothbrush in the treat ment of periodontitis. JA D A 41:158 Aug. 1950. 4. Scherp, Henry W. Current concepts in periodontal disease research: epidemiological contributions. JADA 68:667 May 1964.