Clinical Evaluation of the Efficacy and Safety of an Ultrasonic Toothbrush System in an Elderly Patient Population

Transcription

1 Clinical Evaluation of the Efficacy and Safety of an Ultrasonic Toothbrush System in an Elderly Patient Population By C.C. Whitmyer/G.T. Terezhalmy/D.L. Miller/M.E. Hujer Impaired manual dexterity in elders can compromise the ability to remove dental plaque adequately with a manual toothbrush. Abstract: Twelve dentulous patients, age 65 or older, with no medical or pharmacologic predisposition to gingival hyperplasia were enrolled in a controlled clinical trial to evaluate the effect of the unaided use of an ultrasonic toothbrush on supragingival plaque and gingival bleeding. Subjects used the ultrasonic toothbrush in lieu of their conventional toothbrushes for a 30-day period. Clinical measurements of the plaque index and bleeding index were made at baseline and at 15 and 30 days. At the end of the 30-day test period, the use of the ultrasonic toothbrush resulted in significant reductions in plaque score, proportion of high plaque surfaces, and bleeding index. The reduction of the bleeding index indicates significant improvement in oral health. In this study, the use of an ultrasonic tooth- brush effectively improved oral hy- giene and health in a population that often exhibits decreased manual dex- terity. Strategies for oral health care assessment and education for guid- ance of effective interventions are in- cluded in checklist form; level of care classification, cost in both time in- volved and equipment, and purchase instructions also are discussed. Further study is warranted to evaluate this instrument for cognitively impaired elders, who often rely on caregivers for oral hygiene procedures. (Geriatr Nurs 1998;19:29-33.) Geriatric Nursing Volume 19, Number 1 29

2 ental decay and gingival bleeding are excellent diagnostic indicators of oral health and hygiene. The most recent national survey conducted by the National Institute of Dental Research (NIDR ) concluded that elderly patients, age 65 and older, share a disproportional percentage of the oral disease burden (dental caries, gingival bleeding, periodontal disease, tooth loss) among United States adults. 1 Senior citizens were found to have a mean of 1.46 decayed root surfaces versus 0.40 for employed adults (age 18 to 64). In addition, senior citizens displayed roughly twice the number of sites with gingival bleeding (Table 1). Oral disease as a result of improper oral hygiene has been linked to systemic dissemination of oral infection in individuals age 50 and older. 2 Although the rate and location of plaque formation varies among individuals and is a result of influences of diet, age, salivary factors, anatomic considerations, systemic diseases, and other host modifiers, the importance of bacteria in dental plaque and its role in the cause of dental caries and periodontal disease is well-established in the literature. Patients can remain relatively plaque-flee if they follow proper home care procedures, and plaque control can arrest and prevent dental caries and periodontal disease. However, elderly patient populations have demonstrated diminished manual agility, which limits their ability to carry out effective plaque removal on a daily basis with a conventional toothbrush and dental floss. 3 Consequently, the ideal toothbrush design should be innovative enough to increase effectiveness in individuals with average to below-average manual dexterity and cognitive ability to comply with prescribed hygiene practices. Since the earliest recorded evidence of the natural bristle toothbrush as a plaque fighter? the evolution of toothbrushes has led to the development of three distinct technologies: manual brushes, electromechanical brushes, and ultrasonic brushes (Table 2). Axelsson and Lindhe 5 concluded that patients can remain relatively plaque-free if they follow proper home care procedures. However, given average dexterity, no specific manual toothbrush design has been shown to be superior for plaque removal. 6,7 The new electromechanical brushes use modest variations of a rotary or oscillating motion 8 at a "sonic" speed. Some are faster than others, and the most aggressively oscillating brush vibrates at 520 strokes per second. In both short-term and long-term studies, electromechanical brushes prove more effective than conventional brushes in reducing plaque and gingivitis in all age groups. 9-n The ultrasonic brushes seem to be more effective. The ultrasonic toothbrush combines a manual toothbrush and a piezoelectric ultrasonic emitter (transducer) embedded in the brush head (Figure 1). The ultrasonic emitter is driven by a power supply located in the handle, operating at 1.6 MHz. Toothpaste is used to couple the ultrasonic waves to the teeth and soft tissues. Studies evaluating the efficacy and safety of an ultrasonic toothbrush versus a conventional toothbrush concluded that the ultrasonic toothbrush was significantly more effective in removing plaque and reducing gingivitis and gingival bleeding, and it is a safe and effective adjunct to professional dental care to maintain oral healthy, TM This clinical study was designed to determine whether the unaided use of an ultrasonic toothbrush was superior to a manual toothbrush in removing supragingival plaque and reducing gingival bleeding in elderly outpatients. TABLE 1. THE ORAL DISEASE BURDEN OF WORKING ADULTS AND SENIORS Percent of edentulous patients Mean number of teeth Mean number of decayed coronal surfaces Mean number of decayed ': root surfaces Mean number of gingival bleeding sites Working Seniors adults [18- (>6_5 yrs old) 64 yrs old) ,83 National Institute of Dental Research--Oral Health of the United States Adults, The national survey of oral health in U.S. employed and ~en/ors." Bethesda (MD): U.S. Department of Health and Human Services; DHHS publication number (NIH) TABLE 2. TOOTHBRUSH TYPES, Type Motion type Motion controlled by Motion powered by Manual Manual User Electromechanical Sideways vibrating brush head Vertically vibrating brush head Rotating tufts Rotating brush head Ultrasonic Manual, ultrasonically vibrating User. machine brush bristles User Electric motor with circular to linear converter or electric magnet with pivoted linear linkage Electric motor generating harmonic vibrations Electric motor with gears and linkage Electdc motor circular motion User, adjunct ultrasound generated by piezoelectric crystal 30 Geriatric Nursing Volume 19, Number 1

3 T A B L E 3. T H E P L A Q U E INDEX 0 = No plaque 1 = Separate flecks of plaque at the gum line of the tooth 2 = A thin, continuous band of plaque (up to 1 ram) at the cervical margin of the tooth 3 = A band of plaque wider than 1 mm but covering less than one third of the crown of the tooth 4 = Plaque covering at least one third but less than twothirds of the crown of the tooth 5 = Plaque covering two-thirds or more of the crown Ramfjord SR Indices of prevalence and incidence of periodontal disease, J Periodontal 1959;30:51-9. T A B L E 4. T H E B L E E D I N G INDEX Step 1. Insert a commercially available wooden gingival stimulating device between two teeth from the facial, depressing the papilla 1 mm to 2 mm. Step 2. Following a horizontal path of insertion. =nsert and remove the device four times. Step 3. Observe the presence (score 1) or absence (score 0) of bleeding within 15 seconds of the orocedure. Caton JG, Poison AM. The interdental bleeding index: a simplitied procedure for monltorfrn gingival health, Compend Cent Educ Dent 1985;88(2): FIGURE 1. Ultrasonic toothbrush system comprises manual toothbrush and piezoelectric ultrasonic emitter (transducer) embedded in brush head. Ultrasonic emitter is driven by power supply located in handle, operating at 1.6 MHz. Transducer contracts and expands volumetrically in tune with impulses provided by power supply, converting electric energy into ultrasonic waves. Ultrasonic waves are transmitted from transducer to brush head and bristles. Bristle vibration amplitude is microscopic and does not provide any tactile feedback to user. Dentifrice is used to couple ultrasonic waves to teeth and soft tissues. System is fully automated with all solid-state electronics. It turns off automatically when preset dosage is achieved. Ultrasonic brush head is tapered anteriorly (12 mm x 30 mm to 10 mm x 30 mm) for easy access. Brush has long handle (8.5") with large diameter (7/8") to ensure firm grip. Standard bristles are ultrasoft, multitufted, straight trimmed, polished with rounded ends, and made of 5 mil (0.13 mm) nylon monofilament. MATERIAL AND METHODS Twelve subjects, age 65 or older, were recruited for this study. All subjects were using a variety of conventional toothbrushes before enrollment in the study. On each examination day, the subjects reported having not brushed their teeth for 12 to 14 hours to evaluate overnight plaque formation. A safety assessment was made at each followup visit to evaluate potential trauma from the ultrasonic emitter. Areas examined were the tongue, hard and soft palate, gingiva, mucobuccal folds, buccal mucosa, sublingual areas, and the teeth. Patients brushed with a conventional toothbrush at baseline and with an ultrasonic toothbrush on day 15 and day 30 for precisely 3 minutes. G e r i a t r i c N u r s i n g V o l u m e 19, N u m b e r I The plaque index (Table 3) was measured before and after brushing at all three visits. 15 The bleeding index (Table 4) was measured once, before brushing, at each visit. 16To obtain a single index value (plaque index, bleeding index) per patient, an average index was obtained by dividing the total score by the number of tooth surfaces examined. The percentage of high plaque surfaces (tooth surfaces representing the highest concentrations of plaque) was calculated as described in a study by Turesky et al. 17 RESULTS The results are based on 12 outpatient subjects with a mean age of 73 years and an age range of 69 to 78 years. The unaided use of a conventional toothbrush by elderly patients resulted in 29% plaque removal and a 38% reduction in the proportion of high plaque surfaces after overnight plaque formation. The ultrasonic toothbrush removed, on average, 44% of the plaque, resulting in a 53% reduction in the proportion of high plaque surfaces. DISCUSSION It is universally accepted that a direct correlation exists between plaque accumulation and gingival inflammation. Subgingival bacteria can induce one or more aspects of periodontal diseases, including inflammation and vasculitis, and manifest clinically as gingival bleeding, pocket formation (apical migration of the functional epithelium 31

4 FIGURE 2. Oral health assessment TABLE 5. INSTRUCTIONS TO THE PATIENT The ultrasonic toothbrush is an instrument that enables you to use high-frequency ultrasound waves to reduce plaque formation and gum inflammation. You will neither see movement nor hear sound. A new application of ultrasonography in dentistry was made available to the general public in December 1992 after receiwng approval from the Food and Drug Administration to market the instrument in the United States. You are getting the ultrasonic treatment while you are brushing your teeth tn a normal way. To reduce inflammation, it is critical that the gums and the gingival pockets between the gum and your teeth are reached by the ultrasound waves. The bristles should be Dositioned over the junction of the gums and teeth. You must use the ultrasonic toothbrush for the full 3 minutes twice a day for the beneficial effects of the ultrasound. When you remove the unit from its base. the red light will come on, indicating the ultrasonic toothbrush is on. Wet the bristles, apply the toothpaste quickly, and begin urushing immediately. Continue brushing until the red light goes off, indicating the end of the ultrasonic cycle. Remember, this unit works in silence. No noise or movement will be perceived hence the term ultrasound. 1. How often does the elder routinely visit a dentist? bi-aunually annually emergencies only never unknown Does the elder have: own teeth partial denture no teeth How often does the eider usually brush teeth? crowns once daily twice daily three times daily never 4. Are there any pre-existing oral conditions: None xerostomia (dry mouth) oral cancer other adverse conditions 5. What risk factors for periodontal disease are present? none reduced manual dexterity multiple diagnoses (more than 3) sensory impairment no family support restricted transportation limited rmances lack of motivation dentures uppers lowers occasionally denn car~ impaired cognition multiple medications (include all medications, both prescription and over the counter) along the root surface), alveolar bone loss, and tooth mobility Although bleeding does not differentiate between gingivitis and periodontitis, its presence provides an objective diagnostic sign that can be easily monitored and used to evaluate areas inaccessible for visual inspection. In this study, the bleeding index was statistically smaller (p < 0.001) at both day 15 and day 30 than at baseline, suggesting that the amount of plaque removed by the ultrasonic toothbrush on a daily basis was significant both clinically and statistically (p < 0.001). CLINICAL IMPLICATIONS Impaired manual dexterity in elders can compromise the ability to remove dental plaque adequately with a manual toothbrush. A study was conducted of 52 elderly patients from various settings on methods to identify deficient toothbrushing abilityj 8 The study indicated that consideration should be given to assist elderly subjects who have decreased manual dexterity by supplyingan electric or modified toothbrush. The belief that aging results in tooth loss is a myth. Although age-related changes do adversely affect the tooth enamel and supporting bone structure, pathologic conditions, such as periodontal disease, cause the harm to teeth but can be prevented29 The ultrasonic toothbrush can be effectively used in this role with this population. The device combines the ease of timing by a red light indicator with effective plaque removal action. The handle of the brush is large enough to grip safely, and the head of the device can be changed easily with simple instructions. The only restriction for use is in patients with pacemakers because of the ultrasonic transducer's ability to adversely affect pacemaker function. Institutionalization and impaired cognition in elders are additional indicators for use of the ultrasonic toothbrush. According to Niessen and Douglass, 20 some patients and staff in nursing homes have found electric toothbrushes to be effective in controlling dental plaque formation; however, the authors report that staff education in daily oral hygiene for dependent elders is lacking in institutional settings. Independent elders and the caregivers of dependent elders can be instructed on the use and benefits of the ultrasonic toothbrush for improved oral health (Table 5). Felder et a138 discuss tests for the screening of manual dexterity and cognitive ability to assess the need for assistance in oral care. The instructions then are given to the elder or the caregiver as the screening results indicate. First, verbal instructions are given in understandable language. Second, a written copy of the verbal instructions is given, as well as the written care and operating instructions included with the device. The last step of the education process includes evaluation by return demonstration with time for mutual interaction. Strategies for enhancing dental care and knowledge of risk factors for detecting and predicting periodontal disease are necessary for this population. Assessment with positive interventions and ongoing evaluation of oral health provides the basis for an individualized plan of 32 Geriatric Nursing Volume 19, Number I

5 TABLE 6. CLASSIFICATION OF ORAL CARE ABILITY WITH ULTRASONIC TOOTHBRUSH Level of care Independent Assistance needed Dependent Description Able to perform twice-daily brushing with the ultrasonic toothbrush. Able to change toothbrush heads. No restrictions. Requires help with any part of twice-daily brushing routine. Requires help to change toothbrush head. Unable to perform any part of the twicedaily brushing process, Unable to change toothbrush head. care. Figure 2 provides a baseline assessment checklist for an accurate assessment of risk factors, including oral health habits, multiple medications, multiple diagnoses, and psychologic concerns. Table 6 describes the classification of elders by levels of care and support they need to enhance oral health. These tables serve as guidelines for establishing an effective educative-supportive process and can be modified as needed. The results of the oral health assessment plus the classification of level of care key into the individualized need of the elder and serve as a basis for enhancing oral care. For example, elderly people optimally should seek dental checkups biannually, have their own teeth, and brush twice a day to minimize risk factors of periodontal disease. The assessment and classification level will take the oral health care professional 5 minutes to complete and can be updated at subsequent visits. If assistance is needed with brushing, 6 minutes total each day (3 minutes per brushing) is required. The elder should be informed that neither Medicare nor any health insurance reimburses for the unit. The cost to the elder includes $100 for the ultrasonic toothbrush and $15 for three replacement brushes (1 year's supply). The unit and brushes are available through the mail and at drugstores. An educational protocol (Table 7) for routine oral hygiene with the ultrasonic toothbrush will improve daily brushing habits, decrease supragingival plaque formation, and reduce gingival bleeding. Development of this protocol must include a routine of brushing twice daily. Documenting the education with the ultrasonic toothbrush and periodic dental examinations will improve oral health for both independent and dependent elderly people. REFERENCES 1. National Institute of Dental Research--Oral Health of the United States Adults. The national survey of oral health in U.S. employed and seniors: Bethesda (MD): U.S. Department of Health and Human Services; DHHS publication number (NIH) Navazesh M' Mulligan R' Systemic disseminati n as a result f ral infecti n in individuals 50 years of age and older. Special Care in Dentistry 1995;15: Blahut E A clinical trial of the Interplak-powered toothbrush in a geriatric population. Compend Contin Educ Dent 1993;14(suppl 16):s Li Y, Zhang B, Christen A. The historical development of dentistry in China. Bull Hist Dent 1987;35:21-8, TABLE 7. EDUCATIONAL PROTOCOL FOR ROUTINE ORAL HYGIENE 1. Evaluate the elder's ability. (Table 6} 2. Evaluate the elder's oral health risks. (Figure 2) 3. Initially classify each elder's overall oral health risk on the basis of the information gained in Figure 2 and Table Verbally review toothbrush use instructions in layman's terms. 5. Review toothbrush use with written instructions.* 6. Evaluate by returning to demonstrate with time for mutual interaction. 7. Assist with toothbrushing as necessary. 8. Encourage/arrange biannual dental evaluations. 9. Periodically review brushing instructions and reclassification of ability and oral health risks. (information obtained at biannual dental evaluations will assist in reclassification.) *Instructional aids on proper toothbrushing and other oral hygiene techniques are available from the American Dental Association ( ). 5. Axelsson E Lindhe J. Efficacy of mouth rinses in inhibiting dental plaque and gingivitis in man. J Clin Periodontol 1987;14: Park KK, Matis BA, Christen AG. Choosing an effective toothbrush. Clin Prev Dent 1985;7: Reardon RC, Cronin M, Balbo F. Four clinical studies comparing the efficacy of fiat-trim and multilevel trim commercial brushes. J Clin Dent 1993;4: Mandel ID. The plaque fighters: choosing a weapon. J Am Dent Assoc 1993;124: Youngblood JJ, Killoy W, Love JW, Drisko C, Effectiveness of a new home plaque removal instrument in removing subgingival and interproximal plaque: a preliminary in vivo report. Compend Cont Educ Dent 1985;6:$ Wilson S, Levine D, Dequincy G, Killoy W. Effects of two toothbrushes on plaque, gingivitis, gingival abrasion, and recession: a 1-year longitudinal study [abstract]. J Dent Res 1993;72: Yukua RA, Shaklee RL. Interproximal versus midradicular effects of a counterrotational-powered brush during supportive periodontal therapy. Compend Confin Educ Dent 1993;14(suppl 16):s580-s Love JW, Drisko CL, Killoy WJ,]'ira DE, Love JD. Clinical assessmenl of the Interplak-powered toothbrush versus a conventional brush plus floss. Compend Contin Educ Dent 1993;14(suppl 16):s Terezhalmy GT, Gagliardi VB, Rybicki LA, Kauffman MJ. Clinical evaluation of the efficacy and safety of the UltraSonex ultrasonic toothbrush: a 30-day study. Compend Contin Educ Dent 1994;15: Terezhalmy GT, Iffland H, Jelepis C, Waskowski J. Clinical evaluation of the effect of an ultrasonic toothbrush on plaque, gingivitis, and gingival bleeding: a 6-month study. J Prosthet Dent 1995;73: Ramfjord SE Indices of prevalence and incidence of periodontal disease. J Periodontal 1959;30: Caton JG, Polson AM. The interdental bleeding index: a simplified procedure for monitoring gingival health. Compend Cont Educ Dent 1985;88(2): Turesky S, Gilmore ND, Glickman I. Reduced plaque formation by the chloro-methyl analogue of vitamin C. J Periodontol 1970;41: Felder R, James K, Brown C, et al Dexterity testing as a predictor of oral care ability. J Am Geriatr Soc 1994;42: Miller CA. Nursing care of older adults: theory and practice. 2rid ed. Philadelphia: JB Lippincott; Niessen LC, Douglass CW. Preventive actions for enhancing oral health. Clin Geriatr Med 1992;8: C.C. WHITMYER, DDS, is a general practice resident in the Department of Dentistry; G.T. TEREZHALMY, DDS, MA, is the head of the Section of Oral Medicine, Department of Dentistry; and M.E. HUJER, MSN, RN, is a geriatric clinical nurse specialist in the Department of Internal Medicine: Geriatrics at The Cleveland Clinic Foundation in Cleveland, Ohio. D.L. MILLER, DO, is the medical director of the Geriatrics Institute at St. Luke's Hospital in Bethlehem, Pa. Copyright 1998 by Mosby, Inc /98/$ /1/81056 Geriatric Nursing Volume 19, Number I 33