Thumb/Finger Sucking HabitNCT04075617
Cessation of Thumb/ Finger Sucking Habit
A study testing electronic habit reminder and palatal crib in people with Thumb/Finger Sucking Habit, run by Cairo University at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Thumb/Finger Sucking Habit
- What is being tested?
- electronic habit reminder and palatal crib
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2019to 20 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Children with thumb/finger sucking habit.
- After eruption of upper first permanent molar
- open bite
Who cannot join
- Patients with special health care need
- Uncooperative child
- Parents refuse the participation of their child
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Thumb/Finger Sucking Habit
- Being tested
- electronic habit reminder, palatal crib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electronic habit reminderDevice
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 cribOther
Fixed palatal crib is commonly used and recommended for treating thumb/finger sucking habit.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: electronic habit reminder |
| control group | Active comparator | palatal crib will be cemented after impression taking and fabrication Receives: Other: palatal crib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 monthes
Secondary outcomes (3)
child acceptance
Child acceptance is simply by asking the child if he/she comfortable/happy with the appliance. The answer is by yes/no
Measured: 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
Measured: 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
Measured: 6 monthes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2019
- Study start1 Dec 2019
- Primary completion15 Jun 2022
- Study completion20 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Thumb/Finger Sucking HabitStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tassneim Ahmed, Cairo University
- Investigators
- Fatma Korany, Lecturer, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04075617
- Sponsor's protocol ID
- Electronic habit reminder
- Status last verified
- Feb 2024
- First submitted
- 29 Aug 2019
- Last updated
- 7 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only characters of the children thumb/finger sucking habit will be shared and the result and problems faced during the study
Publications
Adair SM. The Ace Bandage approach to digit-sucking habits. Pediatr Dent. 1999 Nov-Dec;21(7):451-3.
PubMed 10633521Barber; 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.
PubMed 26846264Hertzog MA. Considerations in determining sample size for pilot studies. Res Nurs Health. 2008 Apr;31(2):180-91. doi: 10.1002/nur.20247.
PubMed 18183564Insabralde 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.
PubMed 27159552Krishnappa 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.
PubMed 27461817Marwah, 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.
PubMed 27615261Severo 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.
PubMed 27047881Shetty 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.
PubMed 21157057Eltager 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.
PubMed 39762827
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cessation of Thumb/Finger Sucking Habit in Children Using Electronic Habit Reminder Versus Palatal Crib.Randomized Clinical Pilot Study.
- ClinicalTrials.gov ID
- NCT04075617
- Acronym / sponsor ID
- Electronic habit reminder
- Conditions
- Thumb/Finger Sucking Habit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 20 Jun 2022 (actual)
- First posted
- 3 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Device: electronic habit reminderelectronic 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. |
| control group | Active comparator | Other: palatal cribpalatal crib will be cemented after impression taking and fabrication |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Children with thumb/finger sucking habit.
- After eruption of upper first permanent molar
- open bite
Key exclusion criteria (3 listed)
- Patients with special health care need
- Uncooperative child
- Parents refuse the participation of their child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electronic habit reminderHabit 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 | Device | intervention group |
| palatal cribFixed palatal crib is commonly used and recommended for treating thumb/finger sucking habit. | Other | control group |
Primary outcome
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
3 secondary outcomes
child acceptance
Time frame: 6 monthes
parental acceptance
Time frame: 6 monthes
time for habit cessation
Time frame: 6 monthes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Background: PubMed 10633521Adair SM. The Ace Bandage approach to digit-sucking habits. Pediatr Dent. 1999 Nov-Dec;21(7):451-3.
- BackgroundBarber; T.K. and Luke, L. . (1985) Pediatric Dentistry.
- BackgroundDean, 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.
- BackgroundFarsi, N. M. A. and Pedo, C. (1997) 'Najat M.A. Farsi, BDS, MS Fouad S. Salama BDS, MS, Cert Pedo, DABPD, FAAPD'.
- Background: PubMed 26846264Feres 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.
- Background: PubMed 18183564Hertzog MA. Considerations in determining sample size for pilot studies. Res Nurs Health. 2008 Apr;31(2):180-91. doi: 10.1002/nur.20247.
- Background: PubMed 27159552Insabralde 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.
- Background: PubMed 27461817Krishnappa 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.
- BackgroundMarwah, N. (2018) Textbook of Pediatric Dentistry. Jaypee Brothers,Medical Publishers Pvt. Limited. Available at: https://books.google.com.eg/books?id=ZK52DwAAQBAJ.
- BackgroundPaul 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: PubMed 27615261Pisani 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.
- Background: PubMed 27047881Severo 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.
- Individual participant dataSharing planned: No. Only characters of the children thumb/finger sucking habit will be shared and the result and problems faced during the study
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatma Korany, Lecturer study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electronic habit reminder and palatal crib in people with Thumb/Finger Sucking Habit, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cessation of thumb/finger sucking habit (time frame: 6 monthes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04075617, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.