BMC oral health · 2026
Efficacy of a teledentistry-based follow-up approach for monitoring oral health in patients with head and neck cancer after radiotherapy: a noninferiority randomized controlled trial.
СтатьяРандомизированное исследованиеEquivalence TrialНазвание и аннотация: Перевод в очереди
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Pojmonpiti Sungkrit, Witthayawarakul Wisunee, Fuangrod Todsaporn, Suntornchatchaweach Supakorn
Аннотация
OBJECTIVE: To evaluate the efficacy of a teledentistry-based follow-up approach compared with standard in-person follow-up for monitoring oral health among patients with head and neck cancer (HNC) after the completion of radiotherapy, using a noninferiority framework.
METHODS: In this two-arm, noninferiority randomized controlled trial, teledentistry was compared with standard in-person follow-up in patients with HNC after the completion of radiotherapy. The participants were randomized 1:1 and followed up at 1, 3, and 6 months. For teledentistry, a secure digital platform incorporating live video and self-photography was used. The primary outcomes were the percentage of tooth surfaces with plaque (plaque index) and bleeding on probing. The secondary outcomes were radiotherapy-related oral complications (i.e., dental caries incidence, trismus assessed via maximal mouth opening, mucositis severity, xerostomia severity, and osteoradionecrosis incidence) and patient-reported measures, including oral health-related quality of life (Oral Health Impact Profile, OHIP-14) and patient satisfaction. Noninferiority was assessed using analysis of covariance and risk difference calculations, comparing outcomes between groups based on data collected 2 weeks after the 6-month follow-up. A predefined noninferiority margin of 15%, representing the maximum clinically acceptable difference between groups, was applied with 95% confidence intervals (CI).
RESULTS: Twenty-seven participants completed the study (teledentistry group: n = 14; standard group: n = 13), with no statistically significant baseline differences. Teledentistry was noninferior to standard follow-up for the plaque index (mean difference: 1.9% points; 95% CI [- 8.6, 12.4]) and bleeding on probing (mean difference: -2.2% points; 95% CI [- 17.2, 12.8]). The incidence of osteoradionecrosis was also noninferior (risk difference: -0.15; 95% CI [- 0.35, 0.04]). Patient satisfaction was high across the groups. Outcomes related to other radiotherapy-related oral complications and oral health-related quality of life were inconclusive.
CONCLUSION: Teledentistry appears to be a feasible and noninferior follow-up modality for patients with HNC during the initial 6 months after radiotherapy.
TRIAL REGISTRATION: TCTR20221008001, registered on October 8, 2022.
METHODS: In this two-arm, noninferiority randomized controlled trial, teledentistry was compared with standard in-person follow-up in patients with HNC after the completion of radiotherapy. The participants were randomized 1:1 and followed up at 1, 3, and 6 months. For teledentistry, a secure digital platform incorporating live video and self-photography was used. The primary outcomes were the percentage of tooth surfaces with plaque (plaque index) and bleeding on probing. The secondary outcomes were radiotherapy-related oral complications (i.e., dental caries incidence, trismus assessed via maximal mouth opening, mucositis severity, xerostomia severity, and osteoradionecrosis incidence) and patient-reported measures, including oral health-related quality of life (Oral Health Impact Profile, OHIP-14) and patient satisfaction. Noninferiority was assessed using analysis of covariance and risk difference calculations, comparing outcomes between groups based on data collected 2 weeks after the 6-month follow-up. A predefined noninferiority margin of 15%, representing the maximum clinically acceptable difference between groups, was applied with 95% confidence intervals (CI).
RESULTS: Twenty-seven participants completed the study (teledentistry group: n = 14; standard group: n = 13), with no statistically significant baseline differences. Teledentistry was noninferior to standard follow-up for the plaque index (mean difference: 1.9% points; 95% CI [- 8.6, 12.4]) and bleeding on probing (mean difference: -2.2% points; 95% CI [- 17.2, 12.8]). The incidence of osteoradionecrosis was also noninferior (risk difference: -0.15; 95% CI [- 0.35, 0.04]). Patient satisfaction was high across the groups. Outcomes related to other radiotherapy-related oral complications and oral health-related quality of life were inconclusive.
CONCLUSION: Teledentistry appears to be a feasible and noninferior follow-up modality for patients with HNC during the initial 6 months after radiotherapy.
TRIAL REGISTRATION: TCTR20221008001, registered on October 8, 2022.