Clinical trial NCT04075617: Cessation of Thumb/ Finger Sucking Habit
Official title: Cessation of Thumb/Finger Sucking Habit in Children Using Electronic Habit Reminder Versus Palatal Crib.Randomized Clinical Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thumb/Finger Sucking Habit
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-09-03
Enrollment: 22
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cessation of thumb/finger sucking habit
timeFrame: 6 monthes
Secondary outcomes:
measure: child acceptance
timeFrame: 6 monthes
measure: parental acceptance
timeFrame: 6 monthes
measure: time for habit cessation
timeFrame: 6 monthes
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry
Study officials:
affiliation: Cairo University
name: Fatma Korany, Lecturer
role: STUDY_DIRECTOR
References:
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citation: Barber; T.K. and Luke, L. . (1985) Pediatric Dentistry.
citation: 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.
citation: Farsi, N. M. A. and Pedo, C. (1997) 'Najat M.A. Farsi, BDS, MS Fouad S. Salama BDS, MS, Cert Pedo, DABPD, FAAPD'.
citation: 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.
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citation: 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.
citation: 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.
citation: Marwah, N. (2018) Textbook of Pediatric Dentistry. Jaypee Brothers,Medical Publishers Pvt. Limited. Available at: https://books.google.com.eg/books?id=ZK52DwAAQBAJ.
citation: 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).
citation: 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.
citation: 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.
citation: 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.