The aim of this study is to evaluate the clinical use of the smartphone application "Ortodontika" for the compliance of orthodontic patients with Rapid Maxillary Expander (RME). Patients and parents consenting to participate in the study will sign the informed consent for their child. At the baseline (T0), a periodontal examination will be carried out by means of a probe assessing Bleeding Index, Plaque Index and Modified Gingival Index on upper first incisors, first premolars/first primary molars and first molars. A professional oral hygiene will be performed using a piezoelectric instrument and a manual scaler. A RME will be cemented with a glass ionomer cement on the maxillary first molars and will be activated by parents on clinicians' instructions. Patients will receive an oral hygiene kit containing toothpaste, soft-bristled toothbrush, single tufted brush and interdental brushes (0.6 and 0.9 mm). Orthodontic wax and 1% chlorhexidine will be given for emergencies. At this point, patients will be divided into two groups: * Control group: verbal instructions on the correct activation of the RME and on its cleaning will be given to parents at each visit, together with verbal instructions on the correct daily practices for oral hygiene; * Trial group: use of "Ortodontika" smartphone application as adjunct to verbal instructions on the correct activation of the RME to be performed by one parent, through a daily notification until T1 (end of activations); parents have to supervise daily oral hygiene of RME and the correct daily practices for oral hygiene. A notification will be sent every 2 weeks until the end of the study to remind patients to watch the videos on oral hygiene maneuverers. Patients will be visited at the end the activations (T1), after 1.5 months (T2), after 3 (T3) and 6 months (T6). At the recall, the periodontal indices will be evaluated again. At each recall, extra products will be given for home oral hygiene Patients and parents from the Control group will receive a questionnaire to evaluate awareness of orthodontic therapy (aims and phases) and knowledge of oral hygiene maneuverers. Patients and parents from the Trial group will receive an extra questionnaire about Ortodontika application. During the study, the number of emergencies will be recorded.
The aim of this study is to evaluate the clinical use of the smartphone application "Ortodontika" for the compliance of orthodontic patients with Rapid Maxillary Expander (RME). Patients and parents consenting to participate in the study will sign the informed consent for their child. At the baseline (T0), a periodontal examination will be carried out by means of a probe (UNC probe 15; Hu-Friedy, Chicago, IL, USA) assessing Bleeding Index, Plaque Index and Modified Gingival Index on upper first incisors, first premolars/first primary molars and first molars. A professional oral hygiene will be performed using a piezoelectric instrument (Multipiezo, Mectron S.p.a, Carasco, Italy) and a manual scaler (LM23, LM-Dental, Pargas, Finland). A RME will be cemented with a glass ionomer cement (3M Multi-Cure, 3M Unitek, Monrovia, CA, USA) on the maxillary first molars and will be activated by parents on clinicians' instructions. Patients will receive an oral hygiene kit containing toothpaste (GUM Junior 7+, Sunstar Deutschland GmbH, Schonau, Germany), soft-bristled toothbrush (GUM Technique PRO toothbrush), interdental brush 0.6 and 0.8 mm of diameter (GUM TRAV-LER) and a single tufted brush (GUM End-Tuft). Orthodontic wax will be given for emergencies related to RME (GUM ORTHO wax) and 1% chlorhexidine gel (Curasept Periodontal gel, Curasept S.p.A, Saronno, VA, Italy) will be given for gingival inflammation. At this point, patients will be divided into two groups: * Control group: verbal instructions on the correct activation of the RME and on its cleaning will be given to parents at each visit, together with verbal instructions on the correct daily practices for oral hygiene; * Trial group: use of "Ortodontika" smartphone application as adjunct to verbal instructions on the correct activation of the RME to be performed by one parent, through a daily notification until T1 (end of activations); parents will have to supervise daily oral hygiene of RME and the correct daily practices for oral hygiene. A notification will be sent every 2 weeks until the end of the study to remind patients to watch the videos on oral hygiene maneuverers. Patients will be visited at the end of the activations (T1), after 1.5 months (T2), after 3 (T3) and 6 months (T6). At the recall, the periodontal indices will be evaluated and a questionnaire will be given to patients. At each recall, extra products will be given for home oral hygiene. During the study, the number of emergencies will be recorded: RME decementation, patients perceiving pain related to plaque accumulation, mucosal ulcerations due to vestibular tubes, parents that do not understand how to perform RME activations, patients asking the clinician to perform RME activations chairside. A questionnaire will be given to patients and parents belonging to both groups to evaluate awareness of orthodontic therapy aims and phases, knowledge of oral hygiene maneuverers. A questionnaire about Ortodontika application usefulness will be given only to patients and parents belonging to Trial group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
40
parents will download and use Ortodontika smartphone application for all the duration of the study. It will be an aid during orthopedic treatment. During the activations, a notification will be set to remind the daily activation of RME. After the end of the activation protocol, parents will receive a notification every 2 weeks to instruct their children to proper oral hygiene maneuvers. Parents will have to show their children the videos for oral hygiene maintenance every 2 weeks until the end of the study.
verbal instructions will be given chairside to patients and parents regarding RME activation and its cleaning, together with instructions for daily oral hygiene manoeuvres.
Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia
Pavia, Lombardy, Italy
Change in Modified Gingival Index (Eppright et al., 2014)
Scoring criteria (one measurement for each tooth: upper first incisors, first premolars/first primary molars and first molars): 0\. Absence of inflammation 1. Mild inflammation (marginal or papillary unit) 2. Mild inflammation (entire marginal and papillary unit) 3. Moderate inflammation 4. Severe inflammation
Time frame: Baseline (T0), 1 month (end of activations - T1), after 1.5 months (T2), after 3 (T3) and 6 months (T6)
Change in Bleeding Index (Saxton and van der Ouderaa, 1989)
Scoring criteria (mesio-buccal, direct buccal, and disto-buccal probed gingival sulci of upper first incisors, first premolars/first primary molars and first molars): 0\. Absence of bleeding after 30 seconds 1. Bleeding observed after 30 seconds 2. Immediate bleeding
Time frame: Baseline (T0), 1 month (end of activations - T1), after 1.5 months (T2), after 3 (T3) and 6 months (T6)
Change in Plaque Index (Quigley et al. 1962)
Scoring criteria (one measurement for the buccal surface of upper first incisors, first premolars/first primary molars and first molars): 0\. No plaque 1. Discontinuous band of plaque at gingival margin 2. Up to 1-mm continuous band of plaque at gingival margin 3. Band of plaque wider than 1 mm but less than 1/3 of surface 4. Plaque covering between 1/3 and 2/3 of surface 5. Plaque covering 2/3 or more of surface
Time frame: Baseline (T0), 1 month (end of activations - T1), after 1.5 months (T2), after 3 (T3) and 6 months (T6)
Change in Number of emergencies
RME decementation, patients perceiving pain related to plaque accumulation, mucosal ulcerations due to vestibular tubes, parents that do not understand how to perform RME activations, patients asking the clinician to perform RME activations chairside will be collected.
Time frame: Baseline (T0), 1 month (end of activations - T1), after 1.5 months (T2), after 3 (T3) and 6 months (T6)
Change in Awareness questionnaire
Parents and patients from both the groups will complete a questionnaire about their awareness on RME treatment and oral hygiene maneuverers with scores from 0 (worst experience) to 10 (best experience).
Time frame: Baseline (T0), 1 month (end of activations - T1), after 1.5 months (T2), after 3 (T3) and 6 months (T6)
Change in App questionnaire
Parents and patients from Trial group will complete a questionnaire about Ortodontika application usefulness with scores from 0 (worst experience) to 10 (best experience).
Time frame: Baseline (T0), 1 month (end of activations - T1), after 1.5 months (T2), after 3 (T3) and 6 months (T6)
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