Basic ScienceNCT06607536
Clinical Effectiveness of the Calcium Chloride (CaCl2) Surface- Treated Orthodontic Mini Implant (OMI)
A study testing calcium chloride surface treatment in mini implant and Acid Etched in people with Basic Science and Orthodontic Appliance Complication, run by Universiti Teknologi Mara at 1 site in Malaysia.
Trial summary
The goal of this split mouth, randomised control study was to compare the clinical effectiveness of surface treated Calcium Chloride orthodontic mini implant in orthodontic patients. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Basic Science, Orthodontic Appliance Complication, Malocclusion
- What is being tested?
- calcium chloride surface treatment in mini implant and Acid Etched
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteMalaysia
- Study dates
- 9 Jan 2023to 29 Mar 2024
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age range between 18 and 40 years
- Good oral hygiene1
- Patients prescribed with fixed appliance who require extraction of at least one premolar at each quadrant.
- Moderate anchorage demand criteria
- Class II/1 incisor relationship
Who cannot join
- History of previous orthodontic treatment
- Patient who requires combination of orthodontic and orthognathic surgery
- Medically compromised2 or patients who is taking any medication that interferes with bone metabolism.
- Presence of craniofacial syndromes or clefts
- Active periodontal disease
- Poor oral hygiene prior to orthodontic treatment
- Smoking3
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
University Technology Mara Malaysia
Sungai Buloh, Selangor, 47000
About this study
Official title: Clinical Effectiveness of the Calcium Chloride (CaCl2) Surface- Treated Orthodontic Mini Implant (OMI) in a Split-Mouth Randomised Controlled Trial (RCT)
The goal of this split mouth, randomised control study was to compare the clinical effectiveness of surface treated Calcium Chloride orthodontic mini implant in orthodontic patients. The main question[s] it aimed to answer were:
Does the clinical effectiveness based on overall stability in maximum insertion torque and maximum removal torque measurement vary between untreated surface OMI, treated surface OMI with acid etching only and treated surface OMI with acid etching and calcium chloride immersion?, Does the surface roughness of OMI surface post removal vary between untreated surface OMI, treated surface OMI with acid etching only and treated-surface MI with acid etching and calcium chloride immersion? Does the success rate vary between untreated surface OMI, treated surface OMI with acid etching only and treated surface OMI with acid etching and calcium chloride immersion?Does the oral health quality of life and pain vary between untreated surface OMI, treated surface OMI with acid etching only and treated surface OMI with acid etching and calcium chloride immersion? Participants who is eligible for the study , orthodontic patient requiring moderate to high anchorage will be allocated to 2 groups (Group 1 : calcium chloride and control, Group 2 : acid etch, and control) to be used during the orthodontic treatment. The intervention is calcium chloride; the Calcium Chloride, positive control is the acid-etched and control is the machined group OMI. Comparison of the maximum insertion and removal torque, oral health quality of life, success rate and the surface roughness between the different groups of OMI.
Read the detailed description
1.1 Study Design A triple-blinded, three-arm parallel-group randomized controlled trial was conducted at a single center. The trial assesses the effectiveness of an intervention through a split-mouth clinical study design.
1.2 Study Duration This study was carried out from January 2023 until March 2024.
1.3 Ethical Approval Ethical approval (REC/09/2021(FB/56) dated 17 December 2021 was obtained from the Universiti Teknologi MARA Research Ethics Committee (UiTM REC) to carry out the study at Tourmaline Postgraduate Dental Clinic, Faculty of Dentistry, UiTM. This study was conducted by following the ICH Clinical Practice Guidelines, Malaysia Good Clinical Practice Guidelines and the Declaration of Helsinki. (Appendix 1). Informed consent procedures were detailed, outlining participant recruitment methods and the process by which participants were informed about the study\'s purpose, risks, benefits, confidentiality measures, and their right to withdraw.
1.4 Reference Population Orthodontic patients requiring fixed appliance treatment involving extractions of at least one premolar in each quadrant with moderate to high anchorage demand.
1.5 Source Population Registered patient attending clinics in Faculty of Dentistry UiTM who require fixed appliance with moderate to high anchorage demand.
1.6 Sample calculation The sample size calculation was done by using G-power analysis (version 3.1.9.7) based on objectives and the findings of the related studies
1.7 Randomisation and allocation Were done in 2 stages, first stage was to allocate the patient into group 1 ( calcium chloride and control) Group 2 ( acid etch and control). Following that, patient were checked for dominant chewers, and to undergo randomisation for allocation of left and right.
Allocation were randomised by block of two for first and second stage.
1.8 Blinding Patient, clinician and statistician were blinded.
1.9 Preparation of OMI OMI will be sterilised first, and immersed in hydrochloric acid at 65°C for 20 minutes, and to be dried in oven. For acid etch, the OMI will be stored in the vacuum sealed vial. For calcium chloride, it will be immersed in 1.0M Calcium Chloride in 4°C storage.
1.10 Clinical 1.4mmx 8mm OMI was inserted between maxillary first molar and second premolar by 2 experienced and callibrated clinician (MMD and MNMS) OMI was inserted 10mm from the bracket slot and tied with metal ligature to maxillary first molar and second premolar as indirect anchorage during treatment. OMI will be removed once the canine is already in class I. Maximum insertion torque is measured by MTT03-50ZU (Mark-10, Copiague,NY.
At day 1,7 and month 3 after insertion, OHIP-14 will be administered via google form to evaluate patient\'s quality of life. At month 1, 3 and 6, the success of the OMI will be assessed. Success is defined as the ability to maintain the anchorage . Maximum removal torque ( using MTT03-50ZU (Mark-10, Copiague,NY,) is measured after canines are in class I.
1.11 Following removal of the OMI The OMI is assessed under the scanning electron microscop (SEM)
1.12 Statistical analysis Analysis is depending on the distribution of data.
- Being tested
- calcium chloride surface treatment in mini implant, Acid Etched
- Keywords
- orthodontic mini implant, surface treated, anchorage, orthodontics
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calcium chloride surface treatment in mini implantOther
0.1M of Calcium Chloride were used to immersed the orthodontic mini implant
Acid EtchedOther
Mini implant etched in Hydrochloric acid
| Study group | Role | What they receive |
|---|---|---|
| Calcium Chloride | Experimental | Mini implant immersed in the calcium chloride 0.1M solution Receives: Other: calcium chloride surface treatment in mini implant |
| Acid Etch | Active comparator | mini implant etched with hydrochloric acid Receives: Other: Acid Etched |
| machined mini implant | No intervention | non surface treated mini implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum insertion torque and removal torque
Measurement of torque during insertion and removal of the mini implant. The higher the Ncm value, the higher is the stability of the mini implant. The values are directly proportionate to the stability.
Measured: During procedure
Secondary outcomes (3)
Oral Health Quality of Life
OHIP-14 simplified questionaire were distributed to patients to assess the quality of life during treatment with Mini implant. This questionnaire was given at the end of day 1, day 7 and month 3. OHIP-14 is based on summation of score, the higher the score, the worse the quality of life was for the patient. This also assessed the pain score, on VAS scale, the higher the score, the more pain was experienced by patients.
Measured: During procedure
The surface roughness characteristics of the mini implant
The roughness assessed by Scanning electron microscopy (SEM). The shape and the distribution of bony spicules were assessed. Shapes were assessed if they were of the same shape or sizes. The distributions were assessed in terms of whether it was uniform and homegenous or scattered.
Measured: at the end of the study at 12 months
Success rate of mini implant
The success rate within 1 , 3 and 6 months. The success of mini implant is observed by characterised by, no notable mobility and ability to sustain orthodontic force during the treatment. Mobile mini implant that is movable by 3mm are considered as fail mini implant
Measured: From enrolment to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start9 Jan 2023
- Primary completion29 Mar 2024
- Study completion29 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basic ScienceStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3 arm parallel, split mouth
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Teknologi Mara
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Malaysia
- Responsible party
- Principal investigator, Suzanne Husun Reginald Iggan, Universiti Teknologi Mara
- Investigators
- MARYATI MD DASOR, Study chair, UNIVERSITY TECHNOLOGY MARA MALAYSIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06607536
- Sponsor's protocol ID
- REC/09/2021 (FB/56)
- Status last verified
- Sep 2024
- First submitted
- 17 Sep 2024
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effectiveness of the Calcium Chloride (CaCl2) Surface- Treated Orthodontic Mini Implant (OMI) in a Split-Mouth Randomised Controlled Trial (RCT)
- ClinicalTrials.gov ID
- NCT06607536
- Acronym / sponsor ID
- REC/09/2021 (FB/56)
- Keywords
- orthodontic mini implant, surface treated, anchorage, orthodontics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Universiti Teknologi MaraUniversity, hospital or other
- Collaborators
- Ministry of Health, Malaysia
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 29 Mar 2024 (actual)
- Study completion
- 29 Mar 2024 (actual)
- First posted
- 23 Sep 2024 (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 goal of this split mouth, randomised control study was to compare the clinical effectiveness of surface treated Calcium Chloride orthodontic mini implant in orthodontic patients. The main question[s] it aimed to answer were:
Does the clinical effectiveness based on overall stability in maximum insertion torque and maximum removal torque measurement vary between untreated surface OMI, treated surface OMI with acid etching only and treated surface OMI with acid etching and calcium chloride immersion?, Does the surface roughness of OMI surface post removal vary between untreated surface OMI, treated surface OMI with acid etching only and treated-surface MI with acid etching and calcium chloride immersion? Does the success rate vary between untreated surface OMI, treated surface OMI with acid etching only and treated surface OMI with acid etching and calcium chloride immersion?Does the oral health quality of life and pain vary between untreated surface OMI, treated surface OMI with acid etching only and treated surface OMI with acid etching and calcium chloride immersion? Participants who is eligible for the study , orthodontic patient requiring moderate to high anchorage will be allocated to 2 groups (Group 1 : calcium chloride and control, Group 2 : acid etch, and control) to be used during the orthodontic treatment. The intervention is calcium chloride; the Calcium Chloride, positive control is the acid-etched and control is the machined group OMI. Comparison of the maximum insertion and removal torque, oral health quality of life, success rate and the surface roughness between the different groups of OMI.
Detailed description
1.1 Study Design A triple-blinded, three-arm parallel-group randomized controlled trial was conducted at a single center. The trial assesses the effectiveness of an intervention through a split-mouth clinical study design.
1.2 Study Duration This study was carried out from January 2023 until March 2024.
1.3 Ethical Approval Ethical approval (REC/09/2021(FB/56) dated 17 December 2021 was obtained from the Universiti Teknologi MARA Research Ethics Committee (UiTM REC) to carry out the study at Tourmaline Postgraduate Dental Clinic, Faculty of Dentistry, UiTM. This study was conducted by following the ICH Clinical Practice Guidelines, Malaysia Good Clinical Practice Guidelines and the Declaration of Helsinki. (Appendix 1). Informed consent procedures were detailed, outlining participant recruitment methods and the process by which participants were informed about the study\'s purpose, risks, benefits, confidentiality measures, and their right to withdraw.
1.4 Reference Population Orthodontic patients requiring fixed appliance treatment involving extractions of at least one premolar in each quadrant with moderate to high anchorage demand.
1.5 Source Population Registered patient attending clinics in Faculty of Dentistry UiTM who require fixed appliance with moderate to high anchorage demand.
1.6 Sample calculation The sample size calculation was done by using G-power analysis (version 3.1.9.7) based on objectives and the findings of the related studies
1.7 Randomisation and allocation Were done in 2 stages, first stage was to allocate the patient into group 1 ( calcium chloride and control) Group 2 ( acid etch and control). Following that, patient were checked for dominant chewers, and to undergo randomisation for allocation of left and right.
Allocation were randomised by block of two for first and second stage.
1.8 Blinding Patient, clinician and statistician were blinded.
1.9 Preparation of OMI OMI will be sterilised first, and immersed in hydrochloric acid at 65°C for 20 minutes, and to be dried in oven. For acid etch, the OMI will be stored in the vacuum sealed vial. For calcium chloride, it will be immersed in 1.0M Calcium Chloride in 4°C storage.
1.10 Clinical 1.4mmx 8mm OMI was inserted between maxillary first molar and second premolar by 2 experienced and callibrated clinician (MMD and MNMS) OMI was inserted 10mm from the bracket slot and tied with metal ligature to maxillary first molar and second premolar as indirect anchorage during treatment. OMI will be removed once the canine is already in class I. Maximum insertion torque is measured by MTT03-50ZU (Mark-10, Copiague,NY.
At day 1,7 and month 3 after insertion, OHIP-14 will be administered via google form to evaluate patient\'s quality of life. At month 1, 3 and 6, the success of the OMI will be assessed. Success is defined as the ability to maintain the anchorage . Maximum removal torque ( using MTT03-50ZU (Mark-10, Copiague,NY,) is measured after canines are in class I.
1.11 Following removal of the OMI The OMI is assessed under the scanning electron microscop (SEM)
1.12 Statistical analysis Analysis is depending on the distribution of data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- 3 arm parallel, split mouth
| Arm | Type | Receives |
|---|---|---|
| Calcium Chloride | Experimental | Other: calcium chloride surface treatment in mini implantMini implant immersed in the calcium chloride 0.1M solution |
| Acid Etch | Active comparator | Other: Acid Etchedmini implant etched with hydrochloric acid |
| machined mini implant | No intervention | –non surface treated mini implant |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age range between 18 and 40 years
- Good oral hygiene1
- Patients prescribed with fixed appliance who require extraction of at least one premolar at each quadrant.
- Moderate anchorage demand criteria
- Class II/1 incisor relationship
Key exclusion criteria (7 listed)
- History of previous orthodontic treatment
- Patient who requires combination of orthodontic and orthognathic surgery
- Medically compromised2 or patients who is taking any medication that interferes with bone metabolism.
- Presence of craniofacial syndromes or clefts
- Active periodontal disease
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 |
|---|---|---|
| calcium chloride surface treatment in mini implant0.1M of Calcium Chloride were used to immersed the orthodontic mini implant | Other | Calcium Chloride |
| Acid EtchedMini implant etched in Hydrochloric acid | Other | Acid Etch |
Primary outcome
Maximum insertion torque and removal torque
Time frame: During procedure
Measurement of torque during insertion and removal of the mini implant. The higher the Ncm value, the higher is the stability of the mini implant. The values are directly proportionate to the stability.
3 secondary outcomes
Oral Health Quality of Life
Time frame: During procedure
The surface roughness characteristics of the mini implant
Time frame: at the end of the study at 12 months
Success rate of mini implant
Time frame: From enrolment to 6 months
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 23 Sep 2024.
Related trials for Basic Science
Active, not recruiting
Improving Student Mental Health Through a Universal Trauma-Informed Intervention
Anxiety Symptoms, Post-traumatic Stress Symptoms
Recruiting
Behavioral Economic & Staffing Strategies in the ICU
Implementation Science, Delirium
Not yet recruitingObservational study
A Community-based, Peer-led Counseling Service: A Hybrid Type 3 Effectiveness-implementation Study
Psychological Distress, Stress Psychological
Not yet recruiting
Implementing Modified Practices to Leverage Evidence for Movement, Engagement, and Nutrition Topics in Early Childcare and Education
Dietary Intakes, Physical Activity
Enrolling by invitationObservational study
Universal Type 1 Diabetes Screening in Pediatrics
Type 1 Diabetes (T1D)
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.
MARYATI MD DASOR study chair
UNIVERSITY TECHNOLOGY MARA MALAYSIA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing calcium chloride surface treatment in mini implant and Acid Etched in people with Basic Science and Orthodontic Appliance Complication, run by Universiti Teknologi Mara at 1 site in Malaysia.
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 5 inclusion and 7 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 23 Sep 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 Malaysia. 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?
Maximum insertion torque and removal torque (time frame: During procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Sep 2024.