A 6-months Evaluation of Patients' Compliance and Oral Hygiene During Rapid Maxillary Expander (RME) Treatment Using "Ortodontika" Smartphone Application

Summary

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.

Conditions

• Maxillary Transverse Deficiency

Interventions

DEVICE

Ortodontika app

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.

OTHER

Verbal instructions

verbal instructions will be given chairside to patients and parents regarding RME activation and its cleaning, together with instructions for daily oral hygiene manoeuvres.

Sponsors & Collaborators

• University of Pavia

  lead OTHER

Principal Investigators

• Andrea Scribante, DDS, PhD, MS · University of Pavia

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

14 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-10-01

Primary Completion

2025-01-20

Completion

2025-01-29

Countries

• Italy

Study Locations