Cessation of Thumb/ Finger Sucking Habit

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

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).

Study Overview

• Status: Completed
• Conditions: Thumb/Finger Sucking Habit
• Intervention / Treatment: Device: electronic habit reminder; Other: palatal crib

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: tassneim Ahmed, B.D.S; Phone Number: 0201143453703; Email: tassnem.ahmed@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 002
    • Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention group; 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; 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
Active Comparator: control group; palatal crib will be cemented after impression taking and fabrication	Other: palatal crib; Fixed palatal crib is commonly used and recommended for treating thumb/finger sucking habit.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Fatma Korany, Lecturer, Cairo University

Publications and helpful links

General Publications

• Hertzog MA. Considerations in determining sample size for pilot studies. Res Nurs Health. 2008 Apr;31(2):180-91. doi: 10.1002/nur.20247.
• Adair SM. The Ace Bandage approach to digit-sucking habits. Pediatr Dent. 1999 Nov-Dec;21(7):451-3.
• Barber; T.K. and Luke, L. . (1985) Pediatric Dentistry.
• Dean, J. A. (2016) 'Chapter 22 - Managing the Developing Occlusion', in Dean, J. A. (ed.) McDonald and Avery's Dentistry for the Child and Adolescent (Tenth Edition). Tenth Edit. St. Louis: Mosby, pp. 415-478. doi: https://doi.org/10.1016/B978-0-323-28745-6.00022-3.
• Farsi, N. M. A. and Pedo, C. (1997) 'Najat M.A. Farsi, BDS, MS Fouad S. Salama BDS, MS, Cert Pedo, DABPD, FAAPD'.
• Feres MF, Abreu LG, Insabralde NM, de Almeida MR, Flores-Mir C. Effectiveness of open bite correction when managing deleterious oral habits in growing children and adolescents: a systematic review and meta-analysis. Eur J Orthod. 2017 Feb;39(1):31-42. doi: 10.1093/ejo/cjw005. Epub 2016 Feb 3.
• Insabralde NM, de Almeida RR, Henriques JF, Fernandes TM, Flores-Mir C, de Almeida MR. Dentoskeletal effects produced by removable palatal crib, bonded spurs, and chincup therapy in growing children with anterior open bite. Angle Orthod. 2016 Nov;86(6):969-975. doi: 10.2319/011916-49.1. Epub 2016 May 9.
• Krishnappa S, Rani MS, Aariz S. New electronic habit reminder for the management of thumb-sucking habit. J Indian Soc Pedod Prev Dent. 2016 Jul-Sep;34(3):294-7. doi: 10.4103/0970-4388.186750.
• Marwah, N. (2018) Textbook of Pediatric Dentistry. Jaypee Brothers,Medical Publishers Pvt. Limited. Available at: https://books.google.com.eg/books?id=ZK52DwAAQBAJ.
• Paul S. Casamassimo (no date) 'The Thumbgaurd Appliance: Pilot research'. Available at: https://tguard.com/wp-content/uploads/2012/03/southernsmiles.pdf (Accessed: 28 April 2019).
• Pisani L, Bonaccorso L, Fastuca R, Spena R, Lombardo L, Caprioglio A. Systematic review for orthodontic and orthopedic treatments for anterior open bite in the mixed dentition. Prog Orthod. 2016 Dec;17(1):28. doi: 10.1186/s40510-016-0142-0. Epub 2016 Sep 19.
• Severo AL, de Araujo Filho R, Puentes R, Lemos MB, Piluski PF, Lech O. OSTEOID OSTEOMA IN SCAPHOID: CASE REPORT. Rev Bras Ortop. 2015 Nov 4;47(5):656-8. doi: 10.1016/S2255-4971(15)30019-7. eCollection 2012 Sep-Oct.
• Shetty RM, Dixit U, Hegde R, Shivprakash PK. RURS' elbow guard: an innovative treatment of the thumb-sucking habit in a child with Hurler's syndrome. J Indian Soc Pedod Prev Dent. 2010 Jul-Sep;28(3):212-8. doi: 10.4103/0970-4388.73796.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Actual): June 15, 2022
• Study Completion (Actual): June 20, 2022

Study Registration Dates

• First Submitted: August 29, 2019
• First Submitted That Met QC Criteria: August 29, 2019
• First Posted (Actual): September 3, 2019

Study Record Updates

• Last Update Posted (Estimated): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Electronic habit reminder

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only characters of the children thumb/finger sucking habit will be shared and the result and problems faced during the study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No