Condition category
Oral Health
Date applied
04/05/2020
Date assigned
06/05/2020
Last edited
06/05/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

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

Trial website

Contact information

Type

Public

Primary contact

Dr Nor Dayana Mohd Ali

ORCID ID

https://orcid.org/0000-0001-9342-3915

Contact details

Faculty of Dentistry
University Teknologi MARA (UiTM)
Jalan Hospital
Sungai Buloh Campus
Sungai Buloh
47000
Malaysia
+601116670700
nordayana03@gmail.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

600-IRMI 5/1/6

Study information

Scientific title

Clinical assessment of orthodontic mini-implant covers and their effect on oral health quality of life: a randomised controlled trial

Acronym

Study hypothesis

1. 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

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

Study design

Prospective single centred randomised clinical trial with three-arm parallel groups of a prospective 1:1:1 allocation ratio

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

No participant information sheet available

Condition

Oral health (orthodontic)

Intervention

The 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 type

Other

Phase

Drug names

Primary outcome measure

Pain 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 measures

1. 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 trial start date

06/12/2016

Overall trial end date

30/04/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

39 participants. 13 in each group.

Total final enrolment

39

Participant exclusion criteria

1. 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

Recruitment start date

10/11/2017

Recruitment end date

30/04/2019

Locations

Countries of recruitment

Malaysia

Trial participating centre

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

Sponsor information

Organisation

Universiti Teknologi MARA

Sponsor details

Faculty of Dentistry
Jalan Hospital
Sungai Buloh Campus
Sungai Buloh
47000
Malaysia
+60 361266555
noraina@uitm.edu.my

Sponsor type

University/education

Website

http://www.uitm.edu.my/index.php/en

Funders

Funder type

University/education

Funder name

Universiti Teknologi MARA

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The 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 statement:
The current data sharing plans for this study are unknown and will be available at a later date.

Intention to publish date

10/05/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

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