ISRCTN ISRCTN93152504
DOI https://doi.org/10.1186/ISRCTN93152504
Secondary identifying numbers 600-IRMI 5/1/6
Submission date
04/05/2020
Registration date
06/05/2020
Last edited
06/05/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Orthodontic mini-implants are very small (1.5 – 2 mm wide) customised titanium alloy screws which acts as an anchor point in the jaw. Mini-implants are frequently placed between the roots of teeth, but may also be sited in the roof of the mouth. They are then connected to a fixed brace to help move the teeth.
Orthodontic Mini implants is a procedure which is currently popular and commonly used to reinforce anchorage need in an orthodontic treatment. Despite it resulting in absolute anchorage, there are issues (of varying percentages) related to its usage such as pain due to insertion and impingement of the MI head to the buccal mucosa and ulceration, implantitis and failure of the MI to name a few.
Thus the aim of this study is to look further into this matter by means of RCT. The main aim of this study is to evaluate the pain score of patients who are treated with different methods.

Who can participate?
Adult orthodontic patients aged 18 - 30 years, requiring MI placement as part of anchorage reinforcement of their orthodontic treatment, and in good health.

What does the study involve?
Participants will be randomly allocated to receive orthodontic mini implants using three different methods and will be followed up for 30 days.

What are the possible benefits and risks of participating?
The use of the MI covers have shown to help reduce the pain levels in the subjects. The MI covers can be used as a method to help reduce pain and discomfort for patients, by protecting the tongue, cheek and lips from mucosal injury and trauma which could lead to ulceration.
Risks: none

Where is the study run from?
University Teknologi MARA (UiTM), Jalan Hospital Postgraduate Orthodontic Clinic (Malaysia)

When is the study starting and how long is it expected to run for?


Who is funding the study?
Universiti Teknologi MARA (Malaysia)

Who is the main contact?
Dr Nor Dayana Mohd Ali, nordayana03@gmail.com

Contact information

Dr Nor Dayana Mohd Ali
Public

Faculty of Dentistry
University Teknologi MARA (UiTM)
Jalan Hospital
Sungai Buloh Campus
Sungai Buloh
47000
Malaysia

ORCiD logoORCID ID 0000-0001-9342-3915
Phone +601116670700
Email nordayana03@gmail.com

Study information

Study designProspective single centred randomised clinical trial with three-arm parallel groups of a prospective 1:1:1 allocation ratio
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeQuality of life
Participant information sheet No participant information sheet available
Scientific titleClinical assessment of orthodontic mini-implant covers and their effect on oral health quality of life: a randomised controlled trial
Study objectives1. There will be a difference in the pain level and discomfort in all the three groups (Control, Soft Flow and Composite resin)
2. There will be a difference in the occurrence of ulceration in all the three groups (Control, Soft Flow and Composite resin)
3. There will be a difference between the subject’s Oral health-related quality of life (OHRQoL) in all the three groups with or without the MI covers (Control, Soft Flow and Composite resin)
4. There will be a difference in the cost-effectiveness between the mini implant covers used (Soft Flow and Composite resin groups)
Ethics approval(s)Approved 02/11/2017, The Research and Ethics Committee of UiTM (Universiti Teknologi MARA,
Aras 3, Bangunan Wawasan, 40450 Shah Alam, Selangor, Malaysia; +603-55442094; irmiuitm@salam.uitm.edu.my), ref: REC/294/17
Health condition(s) or problem(s) studiedOral health (orthodontic)
InterventionThe patients will be allocated randomly by stratified block randomisation. Recruited patients will be active orthodontic patients that require orthodontic mini implants (MIs) as part of their orthodontic treatment plan.
Three groups involved will be:
1. Control group
2. Soft flow group (SF)
3. Composite resin (CR) group

Only the SF and CR groups receive interventions in which the Soft flow material or the Composite resin material will be placed on the MI head after the MI insertion. The parameters observed will be the Pain score, oral health impact profile and cost-effectiveness of the MI covers as well as the MI failure. The nine different time points are: B0 (baseline- before MI insertion for Control group) and T0 (immediately after MI insertion fr SF and CR groups); T1 (1 hour after MI insertion); T12 (12 Hours after MI insertion); T24 (24 hours after MI insertion); TD2 (2 days after MI insertion); TD3 (3 days after MI insertion); TD7 (7 days after MI insertion); TD14 (14days after MI insertion) and TD30 (30 days after MI insertion).
Intervention typeOther
Primary outcome measurePain score (Numeric Rating Scale) at T0-TD30 at B0 (baseline- before MI insertion for Control group) and T0 (immediately after MI insertion fr SF and CR groups); T1 (1 hour after MI insertion); T12 (12 Hours after MI insertion); T24 (24 hours after MI insertion); TD2 (2 days after MI insertion); TD3 (3 days after MI insertion); TD7 (7 days after MI insertion); TD14 (14days after MI insertion) and TD30 (30 days after MI insertion)
Secondary outcome measures1. Oral health-related quality of life using the Modified Short Oral Health Impact profile -14 (at T0 and TD30)
2. Cost-Effectiveness of the MI covers calculated by comparing the current the cost of each material (per syringe) and the amount of MI covers that are produced by a single syringe
Overall study start date06/12/2016
Completion date30/04/2019

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants39 participants. 13 in each group.
Total final enrolment39
Key inclusion criteria1. Orthodontic patients requiring MI placement as part of anchorage reinforcement of their orthodontic treatment
2. Age 18 years up to 30 years old
3. Healthy patients with no underlying systemic diseases or illness
4. Requiring posteriorly and buccally placed MI on the maxilla or mandible (distal to the canines)
5. Healthy periodontium and good oral hygiene
Key exclusion criteria1. Pre-existing oral soft tissue conditions (such as Recurrent Apthous Stomatitis)
2. Previously failed MI or reinsertion of MI
3. On medications that may alter the oral health status
4. Underlying medical conditions such as diabetes
5. Cleft lip and palate patients
6. Smokers
7. Allergies to metals such as stainless steel or titanium
Date of first enrolment10/11/2017
Date of final enrolment30/04/2019

Locations

Countries of recruitment

  • Malaysia

Study participating centre

University Teknologi MARA (UiTM)
Postgraduate Orthodontic Clinic
Faculty of Dentistry
Jalan Hospital
Sungai Buloh Campus
Sungai Buloh
47000
Malaysia

Sponsor information

Universiti Teknologi MARA
University/education

Faculty of Dentistry
Jalan Hospital
Sungai Buloh Campus
Sungai Buloh
47000
Malaysia

Phone +60 361266555
Email noraina@uitm.edu.my
Website http://www.uitm.edu.my/index.php/en
ROR logo "ROR" https://ror.org/05n8tts92

Funders

Funder type

University/education

Universiti Teknologi MARA

No information available

Results and Publications

Intention to publish date10/05/2020
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planThe publication plan is to divide the trial in 2 parts (two publications). The first part is to report the primary findings on the pain scores and the occurrence of ulceration as well as the dislodgement of the MI covers and cost effectiveness. The second part is to report on the secondary findings which is the oral health impact profile.
IPD sharing planThe current data sharing plans for this study are unknown and will be available at a later date.

Editorial Notes

05/05/2020: Trial’s existence confirmed by The Research and Ethics Committee of UiTM.