GoPerio - impact of a personalized video and an automated two-way text-messaging system in oral hygiene motivation: study protocol for a randomized controlled trial

Valentin Garyga, Florian Pochelu, Béatrice Thivichon-Prince, Walid Aouini, Julie Santamaria, France Lambert, Delphine Maucort-Boulch, Francois Gueyffier, Kerstin Gritsch, Brigitte Grosgogeat, Valentin Garyga, Florian Pochelu, Béatrice Thivichon-Prince, Walid Aouini, Julie Santamaria, France Lambert, Delphine Maucort-Boulch, Francois Gueyffier, Kerstin Gritsch, Brigitte Grosgogeat

Abstract

Background: Oral hygiene is of paramount importance for the preservation of oral health, and for patients affected by periodontal disease establishing an effective oral hygiene routine is the first step of therapy. Several clinical frameworks have been developed to foster behavior change, such as motivational interviewing. However, two obstacles can be identified. First, patients tend to forget the advice they were given during the consultation. Second, it is hard to maintain motivation in the long term, thus leading to relapse. An innovative eHealth solution was designed with the aim to tackle both obstacles and supplement the current clinical standard of care. The primary objective is to compare the full mouth plaque scores of study groups (eHealth plus standard of care versus standard of care only) at 8 weeks of follow up. The main secondary objective is to compare the full mouth bleeding score at 8 weeks of follow up.

Methods/design: The "GoPerio" study is a multicenter, randomized, controlled trial assessing the impact of a novel eHealth concept for oral hygiene motivation (personalized video of oral hygiene routine available for the patient via a cloud server plus interactive text messages) in addition to the current standard of care (motivational interviewing plus tooth scaling and polishing). The minimum sample size required is 86 patients. Participants will be randomized (allocation ratio 1:1): test group (eHealth plus standard of care) versus control group (standard of care only). The primary outcome is oral hygiene as measured by the full mouth (six sites per tooth) plaque control record (PCR) index. The main secondary outcome is gingival inflammation as measured by the full mouth (six sites per tooth) bleeding on probing (BOP) index. Both the primary and the main secondary outcomes are evaluated by blinded and calibrated examiners at 8 weeks of follow up. The other secondary outcomes are patient satisfaction and patient behavior change and motivation.

Discussion: The study will investigate the value of an innovative eHealth approach to strengthen patient motivation for oral hygiene. If proven effective, such an approach would supplement the current clinical standard of care, resulting in improved clinical outcomes with negligible impact on productivity in a dental practice.

Trial registration: ClinicalTrials.gov, NCT03109808. Registered on 12 April 2017.

Sponsor: Hospices Civils de Lyon. BP 2251, 3 quai des Célestins, 69,229 Lyon cedex 02. Protocol version: 1.0 as of 21 September 2016.

Keywords: Dental plaque; Motivational interviewing; Oral hygiene; Patient Compliance; Patient education as topic; Periodontal diseases; Telemedicine; Text messaging; Video; eHealth.

Conflict of interest statement

Authors and investigators did not receive any funding from the industrial partners. However, all centers involved in the present research protocol received materials free of charge (electric toothbrushes, toothpastes, interdental brushes, dental floss, professional prophylaxis materials) and devices (video cameras).

The industrial partners providing materials are:

  1. Futudent/Novocam Medical Innovations Oy, Helsinki, Finland

  2. Philips Personal Health France, Suresnes, France

  3. GC Europe NV, Leuven, Belgium

  4. Ivoclar Vivadent France, Saint-Jorioz, France

  5. Pierre Fabre Oral Care, Castres, France

  6. GABA France, Colgate-Palmolive, Bois-Colombes, France

  7. Komet France SA, Paris, France

No other relationships or activities could appear to have influenced the submitted work.

The industrial partners did not have any involvement in the study design or in the analysis, collection, and interpretation of the data, or in drafting of the manuscript.

Figures

Fig. 1
Fig. 1
Flow chart. 1 PCR = plaque control record. 2 BOP = bleeding on probing. 3 DVSS = dental visit satisfaction scale
Fig. 2
Fig. 2
Schedule of enrollment, interventions, and assessments. eCRF, electronic case report form
Fig. 3
Fig. 3
Content of the study visits. 1 PCR = plaque control record. 2 BOP = bleeding on probing. MI, motivational interviewing

References

    1. Löe H. Oral hygiene in the prevention of caries and periodontal disease. Int Dent J. 2000;50:129–139. doi: 10.1111/j.1875-595X.2000.tb00553.x.
    1. Pihlstrom BL, Michalowicz BS, Johnson NW. Periodontal diseases. Lancet. 2005;366:1809–1820. doi: 10.1016/S0140-6736(05)67728-8.
    1. Löe H, Theilade E, Jensen SB. Experimental gingivitis in man. J Periodontol. 1965;36:177–187. doi: 10.1902/jop.1965.36.3.177.
    1. Meyle J, Chapple I. Molecular aspects of the pathogenesis of periodontitis. Periodontol 2000. 2015;69:7–17. doi: 10.1111/prd.12104.
    1. Bouchard P, Carra MC, Boillot A, Mora F, Rangé H. Risk factors in periodontology: a conceptual framework. J Clin Periodontol. 2017;44:125–131. doi: 10.1111/jcpe.12650.
    1. Lang NP, Schätzle MA, Löe H. Gingivitis as a risk factor in periodontal disease. J Clin Periodontol. 2009;36(SUPPL. 10):3–8. doi: 10.1111/j.1600-051X.2009.01415.x.
    1. Kocher T, Konig J, Dzierzon U, Sawaf H, Plagmann H-C. Disease progression in periodontally treated and untreated patients - a retrospective study. J Clin Periodontol. 2000;27:866–872. doi: 10.1034/j.1600-051x.2000.027011866.x.
    1. Ramseier CA. Potential impact of subject-based risk factor control on periodontitis. J Clin Periodontol. 2005;32:283–290. doi: 10.1111/j.1600-051X.2005.00798.x.
    1. Chapple ILC, Genco R. Diabetes and periodontal diseases: consensus report of the Joint EFP/AAP Workshop on Periodontitis and Systemic Diseases. J Clin Periodontol. 2013;40(SUPPL. 14):S106–S112. doi: 10.1111/jcpe.12077.
    1. Sanz M, Ceriello A, Buysschaert M, Chapple I, Demmer RT, Graziani F, et al. Scientific evidence on the links between periodontal diseases and diabetes: consensus report and guidelines of the joint workshop on periodontal diseases and diabetes by the International Diabetes Federation and the European Federation of Periodontology. J Clin Periodontol. 2017;2017:138–149. doi: 10.1111/jcpe.12808.
    1. Jordan RA, Hong HM, Lucaciu A, Zimmer S. Efficacy of straight versus angled interdental brushes on interproximal tooth cleaning: a randomized controlled trial. Int J Dent Hyg. 2014;12:152–157. doi: 10.1111/idh.12042.
    1. Chongcharoen N, Lulic M, Lang NP. Effectiveness of different interdental brushes on cleaning the interproximal surfaces of teeth and implants: a randomized controlled, double-blind cross-over study. Clin Oral Implants Res. 2012;23:635–640. doi: 10.1111/j.1600-0501.2011.02387.x.
    1. Slot DE, Dörfer CE, Van der Weijden GA. The efficacy of interdental brushes on plaque and parameters of periodontal inflammation: a systematic review. Int J Dent Hyg. 2008;6:253–264. doi: 10.1111/j.1601-5037.2008.00330.x.
    1. van der Weijden GA, Hioe KPK. A systematic review of the effectiveness of self-performed mechanical plaque removal in adults with gingivitis using a manual toothbrush. J Clin Periodontol. 2005;32:214–228. doi: 10.1111/j.1600-051X.2005.00795.x.
    1. Kressin NR, Boehmer U, Nunn ME, Spiro A. Increased preventive practices lead to greater tooth retention. J Dent Res. 2003;82:223–227. doi: 10.1177/154405910308200314.
    1. Eickholz P, Kaltschmitt J, Berbig J, Reitmeir P, Pretzl B. Tooth loss after active periodontal therapy. 1: patient-related factors for risk, prognosis, and quality of outcome. J Clin Periodontol. 2008;35:165–174. doi: 10.1111/j.1600-051X.2007.01184.x.
    1. Newton JT, Asimakopoulou K. Managing oral hygiene as a risk factor for periodontal disease: a systematic review of psychological approaches to behaviour change for improved plaque control in periodontal management. J Clin Periodontol. 2015;42:S36–S46. doi: 10.1111/jcpe.12356.
    1. Miller WR, Rollnick S. Motivational Interviewing: Helping People Change. 3rd Edition. New York: The Guilford Press; 2012.
    1. Kopp SL, Ramseier CA, Ratka-Krüger P, Woelber JP. Motivational interviewing as an adjunct to periodontal therapy—a systematic review. Front Psychol. 2017;8:279. doi: 10.3389/fpsyg.2017.00279.
    1. Stenman J, Lundgren J, Wennström JL, Ericsson JS, Abrahamsson KH. A single session of motivational interviewing as an additive means to improve adherence in periodontal infection control: a randomized controlled trial. J Clin Periodontol. 2012;39:947–954. doi: 10.1111/j.1600-051X.2012.01926.x.
    1. Gao X, Lo ECM, Kot SCC, Chan KCW. Motivational interviewing in improving oral health: a systematic review of randomized controlled trials. J Periodontol. 2014;85:426–437. doi: 10.1902/jop.2013.130205.
    1. Cascaes AM, Bielemann RM, Clark VL, Barros AJD. Effectiveness of motivational interviewing at improving oral health: a systematic review. Rev Saude Publica. 2014;48:142–153. doi: 10.1590/S0034-8910.2014048004616.
    1. Ramseier CA, Suvan JE. Behaviour change counselling for tobacco use cessation and promotion of healthy lifestyles: a systematic review. J Clin Periodontol. 2015;42:S47–S58. doi: 10.1111/jcpe.12351.
    1. Lim LP, Davies WI, Yuen KW, Ma MH. Comparison of modes of oral hygiene instruction in improving gingival health. J Clin Periodontol. 1996;23:693–697. doi: 10.1111/j.1600-051X.1996.tb00595.x.
    1. Glavind L, Zeuner E. Evaluation of a television-tape demonstration for the reinforcement of oral hygiene instruction. J Clin Periodontol. 1986;13:201–204. doi: 10.1111/j.1600-051X.1986.tb01460.x.
    1. Farooqi OA, Wehler CJ, Gibson G, Jurasic MM, Jones JA. Appropriate recall interval for periodontal maintenance: a systematic review. J Evid Based Dent Pract. 2015;15:171–181. doi: 10.1016/j.jebdp.2015.10.001.
    1. Beirne P, Clarkson JE, Worthington HV. Recall intervals for oral health in primary care patients. Cochrane Database Syst Rev. 2007;(4):CD004346.
    1. de Lima ICV, Galvão MTG, Alexandre Hde O, FET L, Araújo TL. Information and communication technologies for adherence to antiretroviral treatment in adults with HIV/AIDS. Int J Med Inform. 2016;92:54–61. doi: 10.1016/j.ijmedinf.2016.04.013.
    1. Pop-Eleches C, Thirumurthy H, Habyarimana JP, Zivin JG, Goldstein MP, de Walque D, et al. Mobile phone technologies improve adherence to antiretroviral treatment in a resource-limited setting: a randomized controlled trial of text message reminders. AIDS. 2011;25:825–834. doi: 10.1097/QAD.0b013e32834380c1.
    1. Lester RT, Ritvo P, Mills EJ, Kariri A, Karanja S, Chung MH, et al. Effects of a mobile phone short message service on antiretroviral treatment adherence in Kenya (WelTel Kenya1): a randomised trial. Lancet. 2010;376:1838–1845. doi: 10.1016/S0140-6736(10)61997-6.
    1. Montes JM, Medina E, Gomez-Beneyto M, Maurino J. A short message service (SMS)-based strategy for enhancing adherence to antipsychotic medication in schizophrenia. Psychiatry Res. 2012;200:89–95. doi: 10.1016/j.psychres.2012.07.034.
    1. Thakkar J, Kurup R, Laba T-L, Santo K, Thiagalingam A, Rodgers A, et al. Mobile telephone text messaging for medication adherence in chronic Disease. JAMA Intern Med. 2016;176:340. doi: 10.1001/jamainternmed.2015.7667.
    1. Eysenbach G. What is e-health? J Med Internet Res. 2001;3:e20. doi: 10.2196/jmir.3.2.e20.
    1. Chan A-W, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158:200. doi: 10.7326/0003-4819-158-3-201302050-00583.
    1. Calvert M, Kyte D, Mercieca-Bebber R, Slade A, Chan A-W, King MT, et al. Guidelines for inclusion of patient-reported outcomes in clinical trial protocols. JAMA. 2018;319:483. doi: 10.1001/jama.2017.21903.
    1. Godard A, Dufour T, Jeanne S. Application of self-regulation theory and motivational interview for improving oral hygiene: a randomized controlled trial. J Clin Periodontol. 2011;38:1099–1105. doi: 10.1111/j.1600-051X.2011.01782.x.
    1. Jönsson B, Öhrn K, Oscarson N, Lindberg P. The effectiveness of an individually tailored oral health educational programme on oral hygiene behaviour in patients with periodontal disease: a blinded randomized-controlled clinical trial (one-year follow-up) J Clin Periodontol. 2009;36:1025–1034. doi: 10.1111/j.1600-051X.2009.01453.x.
    1. Renz A, Ide M, Newton T, Robinson PG, Smith D. Psychological interventions to improve adherence to oral hygiene instructions in adults with periodontal diseases. Cochrane Database Syst Rev. 2007;(2):CD005097.
    1. Stewart JE, Jacobs-Schoen M, Padilla MR, Maeder LA, Wolfe GR, Hartz GW. The effect of a cognitive behavioral intervention on oral hygiene. J Clin Periodontol. 1991;18:219–222. doi: 10.1111/j.1600-051X.1991.tb00418.x.
    1. Lachin JM. Introduction to sample size determination and power analysis for clinical trials. Control Clin Trials. 1981;2:93–113. doi: 10.1016/0197-2456(81)90001-5.
    1. Tonetti MS, Eickholz P, Loos BG, Papapanou P, van der Velden U, Armitage G, et al. Principles in prevention of periodontal diseases. J Clin Periodontol. 2015;42:S5–11. doi: 10.1111/jcpe.12368.
    1. Jepsen S, Blanco J, Buchalla W, Carvalho JC, Dietrich T, Dörfer C, et al. Prevention and control of dental caries and periodontal diseases at individual and population level: consensus report of group 3 of joint EFP/ORCA workshop on the boundaries between caries and periodontal diseases. J Clin Periodontol. 2017;44:S85–S93. doi: 10.1111/jcpe.12687.
    1. Yaacob M, Worthington H, Deacon S, Deery C, Walmsley A, Robinson P, et al. Powered versus manual toothbrushing for oral health (Review). Cochrane Database Syst Rev. 2014;(6):CD002281.
    1. O’Leary TJ, Drake RB, Naylor JE. The plaque control record. J Periodontol. 1972;43:38. doi: 10.1902/jop.1972.43.1.38.
    1. Ainamo J, Bay I. Problems and proposals for recording gingivitis and plaque. Int Dent J. 1975;25:229–235.
    1. Saito A, Kikuchi M, Ueshima F, Matsumoto S, Hayakawa H, Masuda H, et al. Assessment of oral self-care in patients with periodontitis: a pilot study in a dental school clinic in Japan. BMC Oral Health. 2009;9:27. doi: 10.1186/1472-6831-9-27.
    1. Corah NL, O’Shea RM, Pace LF, Seyrek SK. Development of a patient measure of satisfaction with the dentist: the Dental Visit Satisfaction Scale. J Behav Med. 1984;7:367–373. doi: 10.1007/BF00845270.
    1. Department of Periodontology at University of Bern (Switzerland). Periodontal chart online. .
    1. Canham S, Clivio L, Cornu C, Crocombe W, De Bremaeker N, Domingues C, et al. Requirements for certification of ECRIN data centres, with explanation and elaboration of standards, Version 3.0. 2015.
    1. Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c332. doi: 10.1136/bmj.c332.
    1. Calvert M, Blazeby J, Altman DG, Revicki DA, Moher D, Brundage MD, et al. Reporting of patient-reported outcomes in randomized trials. JAMA. 2013;309:814. doi: 10.1001/jama.2013.879.
    1. Eysenbach G. CONSORT-EHEALTH: Improving and standardizing evaluation reports of WEB-BASED AND MOBILE HEALTH INTERVENTIONS. J Med Internet Res. 2011;13:e126. doi: 10.2196/jmir.1923.
    1. Soldani FA, Young L, Jones K, Walsh T, Clarkson JE. One-to-one oral hygiene advice provided in a dental setting for oral health. Cochrane Database Syst Rev. 2008.
    1. Rosalía Vicente M, Madden G. Assessing eHealth skills across Europeans. Heal Policy Technol. 2017;6:161–168. doi: 10.1016/j.hlpt.2017.04.001.
    1. Del Giudice P, Bravo G, Poletto M, De Odorico A, Conte A, Brunelli L, et al. Correlation between eHealth literacy and health literacy using the eHealth literacy scale and real-life experiences in the health sector as a proxy measure of functional health literacy: cross-sectional web-based survey. J Med Internet Res. 2018;20:e281. doi: 10.2196/jmir.9401.
    1. Anderberg P, Eivazzadeh S, Berglund JS. A novel instrument for measuring older people’s attitudes toward technology (TechPH): development and validation. J Med Internet Res. 2019;21:e13951. doi: 10.2196/13951.
    1. Kim H, Xie B. Health literacy in the eHealth era: A systematic review of the literature. Patient Educ Couns. 2017;100:1073–1082. doi: 10.1016/j.pec.2017.01.015.
    1. Scott Kruse C, Karem P, Shifflett K, Vegi L, Ravi K, Brooks M. Evaluating barriers to adopting telemedicine worldwide: a systematic review. J Telemed Telecare. 2018;24:4–12. doi: 10.1177/1357633X16674087.
    1. Wildenbos GA, Jaspers MWM, Schijven MP, Dusseljee-Peute LW. Mobile health for older adult patients: Using an aging barriers framework to classify usability problems. Int J Med Inform. 2019;124:68–77. doi: 10.1016/j.ijmedinf.2019.01.006.
    1. Pretty IA, Edgar WM, Smith PW, Higham SM. Quantification of dental plaque in the research environment. J Dent. 2005;33(3):193–207. doi: 10.1016/j.jdent.2004.10.017.
    1. Turesky S, Gilmore ND, Glickman I. Reduced plaque formation by the chloromethyl analogue of vitamin C. J Periodontol. 1970;41:41–43. doi: 10.1902/jop.1970.41.41.41.
    1. Quigley GA, Hein JW. Comparative cleansing efficiency of manual and power brushing. J Am Dent Assoc. 1962;65:26–29. doi: 10.14219/jada.archive.1962.0184.
    1. Rustogi KN, Curtis JP, Volpe AR, Kemp JH, McCool JJ, Korn LR. Refinement of the Modified Navy Plaque Index to increase plaque scoring efficiency in gumline and interproximal tooth areas. J Clin Dent. 1992;3(Suppl C):C9–12.
    1. Deinzer R, Jahns S, Harnacke D. Establishment of a new Marginal Plaque Index with high sensitivity for changes in oral hygiene. J Periodontol. 2014;85:1730–1738. doi: 10.1902/jop.2014.140285.
    1. Colliot C, Boillot A, Bouchard P. Indices parodontaux. In: Bouchard P, editor. Parodontologie et Dentisterie Implantaire - Volume 1 : Médecine Parodontale. 1st edition. Paris: Lavoisier, Médecine Sciences Publications; 2015. p. 150–4.
    1. Furuichi Y, Lindhe J, Ramberg P, Volpe AR. Patterns of de novo plaque formation in the human dentition. J Clin Periodontol. 1992;19:423–433. doi: 10.1111/j.1600-051X.1992.tb00673.x.
    1. Kumar S, Tadakamadla J, Johnson NW. Effect of toothbrushing frequency on incidence and increment of dental caries. J Dent Res. 2016;95:1–7. doi: 10.1177/0022034516655315.
    1. Eurostat . Internet use by individuals - almost 8 out of 10 internet users in the EU surfed via a mobile or smart phone in 2016. 2016.
    1. Garyga V, Seidel L, Gagnot G, Renèrs M, Lambert F. O082: Oral hygiene instructions and methods: a European survey among dental professionals - the eSIP study. J Clin Periodontol. 2018;45:35. doi: 10.1111/jcpe.81_12913.
    1. World Health Organization - Regional Office for Europe. From innovation to implementation : eHealth in the WHO European region. Copenhagen; 2016.
    1. Macdonald Emma M, Perrin Byron M, Kingsley Michael IC. Enablers and barriers to using two-way information technology in the management of adults with diabetes: A descriptive systematic review. Journal of Telemedicine and Telecare. 2017;24(5):319–340. doi: 10.1177/1357633X17699990.

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