Cases in Bioethics: Health Research Ethics in Southeast Asia
Keywords

consent, assent, vulnerability, dentistry, cerebral palsy, study design, randomized control trial, children, control groups

Cerebral palsy is a neurological condition defined by muscle control problems that occur either during pregnancy or right before or after birth.1 Globally, the condition affects 2 of every 1,000 births and is more common in males. Cerebral palsy is classified depending on severity of disability and the nature of motor symptoms (spastic, dyskinetic, or ataxic). Individuals with cerebral palsy are more likely to experience various oral health problems related to molar eruption, tooth alignment, dental trauma, and bruxism.2

Bruxism is a condition characterized by persistent jaw-muscle action such as teeth clenching or grinding and mandible bracing or thrusting. It appears in two separate circadian patterns: sleep bruxism and awake bruxism.3 Tooth grinding and gnashing can cause muscle hypertrophy of the lower jaw, migraines, temporomandibular dysfunction, and tooth abrasion.4,5 Research estimates that between one-fourth and two-thirds of children with cerebral palsy have bruxism.6 According to a systematic review of the research literature, a dental appliance called an occlusal splint can help mitigate the effects of bruxism.7

A research team recruited children aged 7 to 16 years diagnosed with cerebral palsy with bruxism for a study to test the effectiveness of occlusal splints on bruxism and randomized the participants into an intervention group and a control group. The intervention group was subdivided into two groups, in which one received a soft (silicone) occlusal splint and the other received a hard (acrylic) occlusal splint. The control group did not receive an occlusal splint but were encouraged by parents to be aware of and stop grinding and perform jaw exercises.

After obtaining parental permission/consent, participants were assigned to one of the three study groups and evaluated for management of dental erosion and attrition. Participants were monitored monthly, during which they also received oral hygiene education and standard oral care (including teeth cleaning and restorative treatment as necessary). The researchers observed occlusal splint wear and tear by taking photographs of the device.

Questions

  1. Should the researchers be expected to obtain not only permission from parents/guardians, but also assent from children? What, if any, additional information might be relevant to answering this question?

  2. What do you think about the choice to randomize children to the different study groups? What do the researchers need to demonstrate in order to justify random assignment to each of the three study arms? Would a different study design have been more appropriate?

  3. Do you have any other ethical concerns related to this study? How might they be resolved?

References

Gonçalves, Ginna Kércia Matos, Fabíola Grammatico Carmagnani, Maria Salete Nahás Pires Corrêa, Danilo Antonio Duarte, and Maria Teresa Botti Rodrigues Santos. “Dental Erosion in Cerebral Palsy Patients.” Journal of Dentistry for Children 75, no. 2 (May 1, 2008): 117–20.
Lobbezoo, F., J. Ahlberg, A. G. Glaros, T. Kato, K. Koyano, G. J. Lavigne, R. de Leeuw, D. Manfredini, P. Svensson, and E. Winocur. “Bruxism Defined and Graded: an International Consensus.” Journal of Oral Rehabilitation 40, no. 1 (January 1, 2013): 2–4. https://doi.org/10.1111/joor.12011.
Macedo, Cristiane R, Ademir B Silva, Marco Antonio C Machado, Humberto Saconato, and Gilmar F Prado. “Occlusal Splints for Treating Sleep Bruxism (Tooth Grinding).” Cochrane Database of Systematic Reviews, no. 4 (October 17, 2007). https://doi.org/10.1002/14651858.cd005514.pub2.
Manfredini, Daniele, and Frank Lobbezoo. “Relationship between Bruxism and Temporomandibular Disorders: a Systematic Review of Literature from 1998 to 2008.” Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology, and Endodontology 109, no. 6 (June 2010): e26–50. https://doi.org/10.1016/j.tripleo.2010.02.013.
Miamoto, Cristina Batista, Maria Letícia Ramos-Jorge, Meire Coelho Ferreira, Marise de Oliveira, Raquel Gonçalves Vieira-Andrade, and Leandro Silva Marques. “Dental Trauma in Individuals with Severe Cerebral Palsy: Prevalence and Associated Factors.” Brazilian Oral Research 25, no. 4 (August 2011): 319–23. https://doi.org/10.1590/s1806-83242011000400007.
Osler, William. The Cerebral Palsies of Children. Reprint, London: Mac Keith Press, 1987.
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