Cessation of Thumb/ Finger Sucking Habit

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Thumb/Finger Sucking Habit

Intervention / Treatment
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* Device: electronic habit reminder
* Other: palatal crib


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention group<br>electronic habit reminder will fabricated to treat thumb/finger sucking habit containing two parts: acrylic part specially fabricated for the child finger/thumb connected to the reminder in the shape of wrist watch. | Device: electronic habit reminder<br>* 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<br>|
| Active Comparator: control group<br>palatal crib will be cemented after impression taking and fabrication | Other: palatal crib<br>* Fixed palatal crib is commonly used and recommended for treating thumb/finger sucking habit.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cessation of thumb/finger sucking habit | 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 | 6 monthes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| child acceptance | Child acceptance is simply by asking the child if he/she comfortable/happy with the appliance. The answer is by yes/no | 6 monthes | 
| parental acceptance | 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 | 6 monthes | 
| time for habit cessation | 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 | 6 monthes |