Cessation of Thumb/ Finger Sucking Habit

NCT04075617 | Completed

• 1 other identifier: Electronic habit reminder
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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).

Conditions

Thumb/Finger Sucking Habit

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• child acceptance

  6 monthes

• parental acceptance

  6 monthes

• time for habit cessation

  6 monthes

Study Arms (2)

intervention group

EXPERIMENTAL

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

control group

ACTIVE COMPARATOR

palatal crib will be cemented after impression taking and fabrication

Other: palatal crib

Interventions

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

intervention group

palatal crib OTHER

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

control group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry

Cairo, 002, Egypt

Location

Related Publications (14)

• Adair SM. The Ace Bandage approach to digit-sucking habits. Pediatr Dent. 1999 Nov-Dec;21(7):451-3.

  PMID: 10633521 BACKGROUND

• Barber; T.K. and Luke, L. . (1985) Pediatric Dentistry.

  BACKGROUND

• 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.

  BACKGROUND

• Farsi, N. M. A. and Pedo, C. (1997) 'Najat M.A. Farsi, BDS, MS Fouad S. Salama BDS, MS, Cert Pedo, DABPD, FAAPD'.

  BACKGROUND

• 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.

  PMID: 26846264 BACKGROUND

• Hertzog MA. Considerations in determining sample size for pilot studies. Res Nurs Health. 2008 Apr;31(2):180-91. doi: 10.1002/nur.20247.

  PMID: 18183564 BACKGROUND

• 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.

  PMID: 27159552 BACKGROUND

• 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.

  PMID: 27461817 BACKGROUND

• Marwah, N. (2018) Textbook of Pediatric Dentistry. Jaypee Brothers,Medical Publishers Pvt. Limited. Available at: https://books.google.com.eg/books?id=ZK52DwAAQBAJ.

  BACKGROUND

• 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).

  BACKGROUND

• 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.

  PMID: 27615261 BACKGROUND

• 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.

  PMID: 27047881 BACKGROUND

• 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.

  PMID: 21157057 BACKGROUND

• Eltager T, Bardissy AE, Abdelgawad F. Cessation of thumb/finger sucking habit in children using electronic habit reminder versus palatal crib: a randomized clinical pilot study. BMC Oral Health. 2025 Jan 6;25(1):27. doi: 10.1186/s12903-024-05310-6.

  PMID: 39762827 DERIVED

Study Officials

• Fatma Korany, Lecturer

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Blinding isn't feasible except for the statistician.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: B.D.S, Faculty of Dentistry

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: September 3, 2019
• Study Start: December 1, 2019
• Primary Completion: June 15, 2022
• Study Completion: June 20, 2022
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)