|- candidate number||26733|
|- NTR Number||NTR6206|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||20-feb-2017|
|- Secondary IDs||protocol. nr. 2016.162 The Medical Ethics Committee of VU Medical Centre of Amsterdam|
|- Public Title|| The WhiteTeeth app to promote oral hygiene|
|- Scientific Title||A Randomized Control Trail to Evaluate the Effectiveness a Smartphone Intervention - WhiteTeeth App - in improving Oral Health Behavior and Oral Hygiene in Adolescents with Fixed Orthodontic Appliances|
|- hypothesis||The primary objective of the study is to examine whether the WhiteTeeth app used by orthodontic patients aged 12 to 16 improves oral health behavior and oral hygiene. Primary outcomes of this RCT are dental plaque levels, gingival bleeding upon marginal probing, and oral health behaviors including tooth brushing behavior, the use of dental cleaning aids and fluoride mouth rinse. Secondary outcomes are changes in psychosocial factors of oral health behavior. We will test the mediating effects of psychosocial factors on changes in oral health behaviors and oral hygiene. The hypothesis is that the use of the WhiteTeeth app in the intervention group leads to better oral health behavior and oral hygiene compared to usual care (the control group). We expect that changes in the psychosocial factors are associated with the factual changes in oral health behavior.|
|- Healt Condition(s) or Problem(s) studied||Dental caries, Oral hygiene|
|- Inclusion criteria||Patients are eligible for the study if they meet the following criteria:|
- Boys and girls aged 12 to 16
- For at least 1,5 month maxillary and mandibular fixed orthodontic appliance therapy, which consists of bonding of at least premolar-to-premolar with edgewise appliances and their modifications.
- Not scheduled to remove fixed orthodontic treatment before the end of the study.
- Able to perform their own oral hygiene activities, without physical and/or mental disabilities.
- Not engaged in other oral health education or research program.
- No enamel and dentine dysplasia and/or craniofacial malformation (e.g. cleft).
- Sufficient command of the Dutch language.
- In the possession of smart-phone with the software IOS >7 or Android > 4.1.
- Patients and their parents are able or willing to give informed consent.
- Patients that have not use medication that may affect plaque accumulation, for example antibiotics and antibacterial mouth rinses.
- All patients in the study receive upper and lower fixed orthodontic treatment.
|- Exclusion criteria||See the inclusion/eligibility criteria. |
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||2-dec-2016|
|- planned closingdate||7-jul-2017|
|- Target number of participants||144|
|- Interventions||This study is a parallel randomized controlled trial with two conditions: the experimental group, which receives the WhiteTeeth app in addition to care as usual, and the control group receiving only care as usual. The WhiteTeeth app is a smartphone app which targets oral health behavior of adolescents with fixed orthodontic appliances. The ‘White-teeth’ app integrates several behavior change techniques including information on health consequences, demonstration of the desired behavior, self-monitoring, implementation intentions or planning, volitional sheets, and reminders. Participants in the intervention group receive twelve disclosing tablets (Gum® Red-Cote®) to visualize dental plaque. During the intervention period the participants will monitor their dental plaque levels by taking a selfie of their teeth, and designate the visualized plaque on the selfie.|
|- Primary outcome||The primary outcomes of the study are the presence of dental plaque (measured with a modified Silness and Loë Plaque Index), gingival bleeding (measured with the Bleeding on Marginal Probing Index), and self-reported oral health behaviors. The plaque index will be used to describe the amount of plaque on the buccal surfaces of the first premolars, canines and incisors using a mouth mirror and a probe. The buccal surface of each tooth is divided into four zones according the position of the orthodontic bracket: mesial, distal, gingival and incisal to the bracket. Each of the four sites of the buccal tooth surface is given a score from 0 (absence) to 3. For the bleeding score, three sections (mesio-vestibular, vestibular, disto-vestibular) of the vestibular surfaces of the first premolar, canines and incisors will be assessed to determine whether probing elicited marginal bleeding (score 1) or not (score 0). Data are collected at baseline, and 6 and 12 weeks follow-up. |
|- Secondary outcome||Secondary outcomes include changes in psychosocial factors of the HAPA model, such as outcome-expectancies, intention, action-self-efficacy, coping planning and action control. A self-administered digital questionnaire contains questions with both single and multiple response items concerning oral health behaviors and their psychosocial factors. Data are collected at baseline, and 6 and 12 weeks follow-up. |
|- Timepoints||Data will be collected during three orthodontic check-ups: baseline (T0), 6 weeks (T1) and 12 weeks of follow up (T2).|
|- Trial web site|
|- status||recruitement status not public|
|- CONTACT FOR PUBLIC QUERIES||MSc Janneke F.M. Scheerman|
|- CONTACT for SCIENTIFIC QUERIES||MSc Janneke F.M. Scheerman|
|- Sponsor/Initiator ||Hogeschool INHolland|
(Source(s) of Monetary or Material Support)
|- Brief summary||This study is a parallel randomized controlled trial with two conditions: the experimental group, which receives the WhiteTeeth app in addition to care as usual, and the control group receiving only care as usual. The WhiteTeeth app is a smartphone app which targets oral health behavior of adolescents with fixed orthodontic appliances. The primary outcomes are the presence of dental plaque, bleeding index and self-reported oral health behaviors. Data will be collected during three orthodontic check-ups: baseline (T0), 6 weeks (T1) and 12 weeks of follow up (T2).|
|- Main changes (audit trail)|
|- RECORD||20-feb-2017 - 2-apr-2017|