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Completed

NCT Number: NCT04075617

Cessation of Thumb/ Finger Sucking Habit

The aim of this study is to assess the use of electronic habit reminder and palatal crib in the cessation of thumb/finger sucking habit.

Treatment of thumb/finger sucking by extraoral approaches are well accepted by school-age children (Adair, 1999). It was reported in a case study by Krishnappa et al that the use of an extraoral electronic habit reminder is a new method used for cessation of thumb/finger sucking habit in short time and it is more comfortable and acceptable to the child (Krishnappa et al, 2016).

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Key information

Conditions

Thumb/Finger Sucking Habit

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry

Cairo, 002, Egypt

About this study

This study will be conducted in, Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University. Diagnosis and patient selection will be at outpatient clinic in the specific days of diagnosis. Impression taking, delivery of appliances and follow up will be at post graduate clinic under supervision of the main and assistant supervisor.

Eligible patients will be randomized to form two groups, Intervention group: Treatment by using electronic habit reminder which will be constructed by taking impression for the thumb/finger using silicon impression material (putty consistency) and pouring it with dental stone. The replica of the finger is used to formulate a custom made cover for it, which consists of stainless steel wires with specific design and acrylic resin this is the first part of the reminder. The second part is in the shape of wrist watch which is connected to the first part by a wire. When the child puts his finger in his mouth the stainless steel wires touch each other and the watch produces alarming sound and counts how many times the alarm goes off. The child should wear the appliance most of the time except during eating and activities.

Control group: Treatment by using palatal crib which will be constructed by taking impression for upper arch with alginate impression material, and then will be sent to the lab for fabrication. Cementation of the appliance and then follow up.

Follow up will be at two weeks and 1, 3, 6 months.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children with thumb/finger sucking habit.
  • After eruption of upper first permanent molar
  • open bite

Exclusion criteria

  • Patients with special health care need
  • Uncooperative child
  • Parents refuse the participation of their child

Treatment and study plan

electronic habit reminder

Device

Habit reminder in the form of wrist watch with music that display as reminder is one of recent innovations for cessation of the habit in short time and the child accepts it and it's comfortable

palatal crib

Other

Fixed palatal crib is commonly used and recommended for treating thumb/finger sucking habit.

Primary outcomes

  1. Cessation of thumb/finger sucking habit

    Time frame: 6 monthes

    cessation of thumb/finger sucking habit is by asking the parent in every appointment during the follow up period if the notice that their child has stopped the habit or at least there is decrease in the duration

Secondary outcomes

  1. child acceptance

    Time frame: 6 monthes

    Child acceptance is simply by asking the child if he/she comfortable/happy with the appliance. The answer is by yes/no

  2. parental acceptance

    Time frame: 6 monthes

    Parental acceptance, there is a questionnaire will be handed to the parent at the end of the treatment period to assess if they found that the device was easy to use, instructions was helpful, the appliance helped in the cessation of the habit and if they will recommend it to others all these questions will be answered by scale (very/somewhat/neutral /minimally/not).And the parents can list if there were any problems they faced with the appliance

  3. time for habit cessation

    Time frame: 6 monthes

    Time for habit cessation is assessed by a booklet is handed to the parent at the beginning of the treatment to record the daily thumb/finger habit activity of the child

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Cessation of Thumb/Finger Sucking Habit in Children Using Electronic Habit Reminder Versus Palatal Crib.Randomized Clinical Pilot Study.

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Sep 3, 2019
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.