Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06607536
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-17
Brief Title:
Clinical Effectiveness of the Calcium Chloride CaCl2 Surface- Treated Orthodontic Mini Implant OMI
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical Effectiveness of the Calcium Chloride CaCl2 Surface- Treated Orthodontic Mini Implant OMI in a Split-Mouth Randomised Controlled Trial RCT
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 The main questions 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 immersionDoes 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
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 immersionDoes 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:
11 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
12 Study Duration This study was carried out from January 2023 until March 2024
13 Ethical Approval Ethical approval REC092021FB56 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 study39s purpose risks benefits confidentiality measures and their right to withdraw
14 Reference Population Orthodontic patients requiring fixed appliance treatment involving extractions of at least one premolar in each quadrant with moderate to high anchorage demand
15 Source Population Registered patient attending clinics in Faculty of Dentistry UiTM who require fixed appliance with moderate to high anchorage demand
16 Sample calculation The sample size calculation was done by using G-power analysis version 3197 based on objectives and the findings of the related studies
17 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
18 Blinding Patient clinician and statistician were blinded
19 Preparation of OMI OMI will be sterilised first and immersed in hydrochloric acid at 65C 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 10M Calcium Chloride in 4C storage
110 Clinical 14mmx 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 CopiagueNY
At day 17 and month 3 after insertion OHIP-14 will be administered via google form to evaluate patient39s 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 CopiagueNY is measured after canines are in class I
111 Following removal of the OMI The OMI is assessed under the scanning electron microscop SEM
112 Statistical analysis Analysis is depending on the distribution of data
12 Study Duration This study was carried out from January 2023 until March 2024
13 Ethical Approval Ethical approval REC092021FB56 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 study39s purpose risks benefits confidentiality measures and their right to withdraw
14 Reference Population Orthodontic patients requiring fixed appliance treatment involving extractions of at least one premolar in each quadrant with moderate to high anchorage demand
15 Source Population Registered patient attending clinics in Faculty of Dentistry UiTM who require fixed appliance with moderate to high anchorage demand
16 Sample calculation The sample size calculation was done by using G-power analysis version 3197 based on objectives and the findings of the related studies
17 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
18 Blinding Patient clinician and statistician were blinded
19 Preparation of OMI OMI will be sterilised first and immersed in hydrochloric acid at 65C 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 10M Calcium Chloride in 4C storage
110 Clinical 14mmx 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 CopiagueNY
At day 17 and month 3 after insertion OHIP-14 will be administered via google form to evaluate patient39s 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 CopiagueNY is measured after canines are in class I
111 Following removal of the OMI The OMI is assessed under the scanning electron microscop SEM
112 Statistical analysis Analysis is depending on the distribution of data
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None