Accelerated Tooth Movement IntervalNCT02571348
Optimum Micro-osteoperforations Accelerated Tooth Movement Interval
A study testing micro-osteoperforation in people with Accelerated Tooth Movement Interval, run by University of Malaya at 1 site in Malaysia.
Trial summary
This study is intended to investigate the optimum interval between micro-osteoperforations to accelerate orthodontic tooth movement. Overall, the investigator will be comparing the rate of tooth movement between micro-osteoperforated site and non micro-osteoperforated site. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Accelerated Tooth Movement Interval
- What is being tested?
- micro-osteoperforation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteMalaysia
- Study dates
- Sep 2015to Jun 2017
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Molar Class I malocclusion, molar Class II \& III < ½ unit, requiring extraction of all four permanent first premolar and maximum anchorage control with temporary anchorage device (TAD)
- Average vertical facial proportions
- No systemic disease
- Good oral hygiene
- No history of periodontal therapy
- No current active periodontal disease
Who cannot join
- Vertical skeletal discrepancies eg high angle and low angle
- Systemic disease especially on long term use of antibiotics, phenytoin, cyclosporin, anti-inflammatory drugs, systemic corticosteroid and calcium channel blockers
- Poor oral hygiene for more than 3 visits
- Past periodontal disease
- Current periodontal disease
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Faculty of Dentistry, University of Malaya
Kuala Lumpur, Kuala Lumpur, 50603
About this study
Official title: Optimum Micro-osteoperforations Accelerated Tooth Movement Interval, Related Pain Perception and Impact to Daily Functions - A Randomized Controlled Trial
This study is intended to investigate the optimum interval between micro-osteoperforations to accelerate orthodontic tooth movement. Overall, the investigator will be comparing the rate of tooth movement between micro-osteoperforated site and non micro-osteoperforated site. Next, the investigator will be comparing the rate of orthodontic tooth movement for micro-osteperforation performed at 4, 8 and 12 weeks' intervals. In addition, the investigator will be evaluating the pain intensity and impact of pain on quality of life during different intervals of micro-osteoperforations at 4, 8 and 12 weeks. Finally, the investigator will be comparing the rate of orthodontic tooth movement between maxilla and mandible.
The significance of the outcome is to determine optimum recommended interval for micro-osteopeforation which can be used to accelerate orthodontic tooth movement. By finding out the optimum interval, the investigator can come with a recommended interval of micro-osteoperforation which can be used routinely in patients to fasten orthodontic tooth movement.
Read the detailed description
- TRIAL DESIGN This is a prospective randomized clinical trial and single centre study (Faculty of Dentistry, University of Malaya). Participants included are molar class I malocclusion, molar Class II \& III < ½ unit, requiring extraction of all four permanent first premolar and maximum anchorage control with Temporary Anchorage Device (TAD).
- SAMPLE SIZE CALCULATION Sample size calculation is based on a type 1 error frequency of 5% and the power of the statistical test set at 90% ( P = 0.9, B = 0.1 ) This is based on animal study as a guide to detect at least 50% difference in the rate of tooth movement. ( Teixeira CC et al.,2010). The sample size was calculated based on a formula described by Lisa Kuramoto from Vancouver Coastal Health Research Institute. Total participant needed with be 30 with minimum of 10 participants per group. We anticipate 20% drop-outs based on previous study. Thus, a minimum of 36 participants will be recruited.
- ETHICAL APPROVAL Approval for the conduct of this study had been obtained from Medical Ethics Committee, University of Malaya 5. RANDOMIZATION This study will be conducted by one orthodontic resident together with one orthodontic Consultant from Faculty of Dentistry, University Malaya, who is the main supervisor of this study. A simple randomization method will be employed to assign patient into experimental site and also the for the frequency interval of micro-osteoperforation.
- INTERVENTION Sequence of events during clinical trial is as follows:-
- Diagnostic record taking (Study models, Photographs, and x-ray)
- Randomization for experimental sites in maxilla and mandible \& randomization for interval of micro-osteoperforation (Group 1: 4weeks maxilla \& 8weeks mandible, Group 2: 8weeks maxilla \& 12weeks mandible, Group 3: 12 weeks maxilla \& 4 weeks mandible)
- Treatment planning with Orthodontic Consultant
- Placement of TADs bilaterally in maxilla and mandible \& Clinical calibration for inter-observer error
- Referral for extraction of 14,24,34 and 44 (Extraction must be done within 2 weeks after insertion of TADs)
- One month after extraction, Banding and Bonding of upper and lower preadjusted edgewise fixed appliances (MBT prescription 0.022"x 0.028" slot).
- Arch wire sequence for levelling and aligning are as follows:-
- Upper and lower 0.014 NiTi Arch wire
- Upper and lower 0.018 NiTi Arch wire
- Upper and lower 17 x 25 NiTi Arch wire
- Upper and lower 19 x 25 SS Arch wire
- Dead coil will be placed to maintain the extraction space of premolars
- Interval between each arch wire sequence is 6 weeks
- One month after the insertion of working arch wire, micro-osteoperforations will be performed \& Inter-obverver error measurement will be done 2 weeks after insertion of working arch wire and on the day of mirco-osteoperforations.
- Three micro-osteoperforations will be placed at the buccal aspect on the buccal cortical bone at the site of premolar extraction(experimental site only) and both canine will be retracted bilaterally with NiTi Coil Spring.
- Participants will be given questionnaire after the procedure and the questionnaire will be collected the following visit 11 From now onwards, participants will be reviewed at their respective interval. Either 4,8 or 12 weeks interval.
- This is the critical period of this study in which micro-osteoperforations will be performed and questionnaire will be given to participants.
- Data collection will be conducted for a period of 16weeks(4 months) - during canine retraction
- Conditions
- Accelerated Tooth Movement Interval
- Being tested
- micro-osteoperforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
micro-osteoperforationProcedure or surgery
micro-osteoperforation with mini implant at different interval
| Study group | Role | What they receive |
|---|---|---|
| 4 weeks and 8 weeks | Active comparator | Micro-osteoperforation will be done on either side of the maxilla at 4 weeks interval and the contralateral site will be the control. In mandible, micro-osteoperforation will be done every 8 weeks and the contralateral site will serve as the control Receives: Procedure: micro-osteoperforation |
| 8 weeks and 12 weeks | Active comparator | Micro-osteoperforation will be done on either side of the maxilla at 8 weeks interval and the contralateral site will be the control. In mandible, micro-osteoperforation will be done every 12 weeks and the contralateral site will serve as the control Receives: Procedure: micro-osteoperforation |
| 12 weeks and 4 weeks | Active comparator | Micro-osteoperforation will be done on either side of the maxilla at 12 weeks interval and the contralateral site will be the control. In mandible, micro-osteoperforation will be done every 4 weeks and the contralateral site will serve as the control Receives: Procedure: micro-osteoperforation |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of orthodontic tooth movement between micro osteoperforated site and non micro-osteoperforated site.
Measured: through study completion, an average of 2 years
Secondary outcomes (3)
Rate of orthodontic tooth movement between maxilla and mandible.
Measured: through study completion, an average of 2 years
Rate of orthodontic tooth movement when micro-osteperforation performed at 4, 8 and 12 weeks intervals.
Measured: through study completion, an average of 2 years
Pain intensity and impact of pain on patient's daily functions during different intervals of micro-osteoperforations at 4, 8 and 12 weeks using questionnaire.
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2015 (estimated)
- Study startSep 2015
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Accelerated Tooth Movement IntervalStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wey Mang Check, Principal investigator, Faculty of Dentistry, University of MalayaJennifer Geraldine Doss, Principal investigator, Faculty of Dentistry, University of MalayaSaritha Sivarajan, Principal investigator, Faculty of Dentistry, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02571348
- Sponsor's protocol ID
- DF CD1412/0089(P)
- Status last verified
- Dec 2016
- First submitted
- 5 Oct 2015
- Last updated
- 30 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Alikhani M, Khoo E, Alyami B, Raptis M, Salgueiro JM, Oliveira SM, Boskey A, Teixeira CC. Osteogenic effect of high-frequency acceleration on alveolar bone. J Dent Res. 2012 Apr;91(4):413-9. doi: 10.1177/0022034512438590. Epub 2012 Feb 14.
PubMed 22337699Teixeira CC, Khoo E, Tran J, Chartres I, Liu Y, Thant LM, Khabensky I, Gart LP, Cisneros G, Alikhani M. Cytokine expression and accelerated tooth movement. J Dent Res. 2010 Oct;89(10):1135-41. doi: 10.1177/0022034510373764. Epub 2010 Jul 16.
PubMed 20639508Krishnan V, Davidovitch Z. On a path to unfolding the biological mechanisms of orthodontic tooth movement. J Dent Res. 2009 Jul;88(7):597-608. doi: 10.1177/0022034509338914.
PubMed 19641146Krishnan V, Davidovitch Z. Cellular, molecular, and tissue-level reactions to orthodontic force. Am J Orthod Dentofacial Orthop. 2006 Apr;129(4):469.e1-32. doi: 10.1016/j.ajodo.2005.10.007.
PubMed 16627171Ren Y, Kuijpers-Jagtman AM, Maltha JC. Immunohistochemical evaluation of osteoclast recruitment during experimental tooth movement in young and adult rats. Arch Oral Biol. 2005 Dec;50(12):1032-9. doi: 10.1016/j.archoralbio.2005.04.005. Epub 2005 Jun 15.
PubMed 15963453Long H, Pyakurel U, Wang Y, Liao L, Zhou Y, Lai W. Interventions for accelerating orthodontic tooth movement: a systematic review. Angle Orthod. 2013 Jan;83(1):164-71. doi: 10.2319/031512-224.1. Epub 2012 Jun 21.
PubMed 22720793
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimum Micro-osteoperforations Accelerated Tooth Movement Interval, Related Pain Perception and Impact to Daily Functions - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02571348
- Acronym / sponsor ID
- DF CD1412/0089(P)
- Conditions
- Accelerated Tooth Movement Interval
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 8 Oct 2015 (estimated)
- 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.
This study is intended to investigate the optimum interval between micro-osteoperforations to accelerate orthodontic tooth movement. Overall, the investigator will be comparing the rate of tooth movement between micro-osteoperforated site and non micro-osteoperforated site. Next, the investigator will be comparing the rate of orthodontic tooth movement for micro-osteperforation performed at 4, 8 and 12 weeks' intervals. In addition, the investigator will be evaluating the pain intensity and impact of pain on quality of life during different intervals of micro-osteoperforations at 4, 8 and 12 weeks. Finally, the investigator will be comparing the rate of orthodontic tooth movement between maxilla and mandible.
The significance of the outcome is to determine optimum recommended interval for micro-osteopeforation which can be used to accelerate orthodontic tooth movement. By finding out the optimum interval, the investigator can come with a recommended interval of micro-osteoperforation which can be used routinely in patients to fasten orthodontic tooth movement.
Detailed description
- TRIAL DESIGN This is a prospective randomized clinical trial and single centre study (Faculty of Dentistry, University of Malaya). Participants included are molar class I malocclusion, molar Class II \& III < ½ unit, requiring extraction of all four permanent first premolar and maximum anchorage control with Temporary Anchorage Device (TAD).
- SAMPLE SIZE CALCULATION Sample size calculation is based on a type 1 error frequency of 5% and the power of the statistical test set at 90% ( P = 0.9, B = 0.1 ) This is based on animal study as a guide to detect at least 50% difference in the rate of tooth movement. ( Teixeira CC et al.,2010). The sample size was calculated based on a formula described by Lisa Kuramoto from Vancouver Coastal Health Research Institute. Total participant needed with be 30 with minimum of 10 participants per group. We anticipate 20% drop-outs based on previous study. Thus, a minimum of 36 participants will be recruited.
- ETHICAL APPROVAL Approval for the conduct of this study had been obtained from Medical Ethics Committee, University of Malaya 5. RANDOMIZATION This study will be conducted by one orthodontic resident together with one orthodontic Consultant from Faculty of Dentistry, University Malaya, who is the main supervisor of this study. A simple randomization method will be employed to assign patient into experimental site and also the for the frequency interval of micro-osteoperforation.
- INTERVENTION Sequence of events during clinical trial is as follows:-
- Diagnostic record taking (Study models, Photographs, and x-ray)
- Randomization for experimental sites in maxilla and mandible \& randomization for interval of micro-osteoperforation (Group 1: 4weeks maxilla \& 8weeks mandible, Group 2: 8weeks maxilla \& 12weeks mandible, Group 3: 12 weeks maxilla \& 4 weeks mandible)
- Treatment planning with Orthodontic Consultant
- Placement of TADs bilaterally in maxilla and mandible \& Clinical calibration for inter-observer error
- Referral for extraction of 14,24,34 and 44 (Extraction must be done within 2 weeks after insertion of TADs)
- One month after extraction, Banding and Bonding of upper and lower preadjusted edgewise fixed appliances (MBT prescription 0.022"x 0.028" slot).
- Arch wire sequence for levelling and aligning are as follows:-
- Upper and lower 0.014 NiTi Arch wire
- Upper and lower 0.018 NiTi Arch wire
- Upper and lower 17 x 25 NiTi Arch wire
- Upper and lower 19 x 25 SS Arch wire
- Dead coil will be placed to maintain the extraction space of premolars
- Interval between each arch wire sequence is 6 weeks
- One month after the insertion of working arch wire, micro-osteoperforations will be performed \& Inter-obverver error measurement will be done 2 weeks after insertion of working arch wire and on the day of mirco-osteoperforations.
- Three micro-osteoperforations will be placed at the buccal aspect on the buccal cortical bone at the site of premolar extraction(experimental site only) and both canine will be retracted bilaterally with NiTi Coil Spring.
- Participants will be given questionnaire after the procedure and the questionnaire will be collected the following visit 11 From now onwards, participants will be reviewed at their respective interval. Either 4,8 or 12 weeks interval.
- This is the critical period of this study in which micro-osteoperforations will be performed and questionnaire will be given to participants.
- Data collection will be conducted for a period of 16weeks(4 months) - during canine retraction
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 4 weeks and 8 weeks | Active comparator | Procedure: micro-osteoperforationMicro-osteoperforation will be done on either side of the maxilla at 4 weeks interval and the contralateral site will be the control. In mandible, micro-osteoperforation will be done every 8 weeks and the contralateral site will serve as the control |
| 8 weeks and 12 weeks | Active comparator | Procedure: micro-osteoperforationMicro-osteoperforation will be done on either side of the maxilla at 8 weeks interval and the contralateral site will be the control. In mandible, micro-osteoperforation will be done every 12 weeks and the contralateral site will serve as the control |
| 12 weeks and 4 weeks | Active comparator | Procedure: micro-osteoperforationMicro-osteoperforation will be done on either side of the maxilla at 12 weeks interval and the contralateral site will be the control. In mandible, micro-osteoperforation will be done every 4 weeks and the contralateral site will serve as the control |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Molar Class I malocclusion, molar Class II \& III < ½ unit, requiring extraction of all four permanent first premolar and maximum anchorage control with temporary anchorage device (TAD)
- Average vertical facial proportions
- No systemic disease
- Good oral hygiene
- No history of periodontal therapy
Key exclusion criteria (5 listed)
- Vertical skeletal discrepancies eg high angle and low angle
- Systemic disease especially on long term use of antibiotics, phenytoin, cyclosporin, anti-inflammatory drugs, systemic corticosteroid and calcium channel blockers
- Poor oral hygiene for more than 3 visits
- Past periodontal disease
- Current 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 |
|---|---|---|
| micro-osteoperforationmicro-osteoperforation with mini implant at different interval | Procedure or surgery | 12 weeks and 4 weeks, 4 weeks and 8 weeks, 8 weeks and 12 weeks |
Primary outcome
rate of orthodontic tooth movement between micro osteoperforated site and non micro-osteoperforated site.
Time frame: through study completion, an average of 2 years
3 secondary outcomes
Rate of orthodontic tooth movement between maxilla and mandible.
Time frame: through study completion, an average of 2 years
Rate of orthodontic tooth movement when micro-osteperforation performed at 4, 8 and 12 weeks intervals.
Time frame: through study completion, an average of 2 years
Pain intensity and impact of pain on patient's daily functions during different intervals of micro-osteoperforations at 4, 8 and 12 weeks using questionnaire.
Time frame: through study completion, an average of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2016.
- Results publication: PubMed 22337699Alikhani M, Khoo E, Alyami B, Raptis M, Salgueiro JM, Oliveira SM, Boskey A, Teixeira CC. Osteogenic effect of high-frequency acceleration on alveolar bone. J Dent Res. 2012 Apr;91(4):413-9. doi: 10.1177/0022034512438590. Epub 2012 Feb 14.
- Results publication: PubMed 20639508Teixeira CC, Khoo E, Tran J, Chartres I, Liu Y, Thant LM, Khabensky I, Gart LP, Cisneros G, Alikhani M. Cytokine expression and accelerated tooth movement. J Dent Res. 2010 Oct;89(10):1135-41. doi: 10.1177/0022034510373764. Epub 2010 Jul 16.
- Results publication: PubMed 19641146Krishnan V, Davidovitch Z. On a path to unfolding the biological mechanisms of orthodontic tooth movement. J Dent Res. 2009 Jul;88(7):597-608. doi: 10.1177/0022034509338914.
- Results publication: PubMed 16627171Krishnan V, Davidovitch Z. Cellular, molecular, and tissue-level reactions to orthodontic force. Am J Orthod Dentofacial Orthop. 2006 Apr;129(4):469.e1-32. doi: 10.1016/j.ajodo.2005.10.007.
- Results publication: PubMed 15963453Ren Y, Kuijpers-Jagtman AM, Maltha JC. Immunohistochemical evaluation of osteoclast recruitment during experimental tooth movement in young and adult rats. Arch Oral Biol. 2005 Dec;50(12):1032-9. doi: 10.1016/j.archoralbio.2005.04.005. Epub 2005 Jun 15.
- Results publication: PubMed 22720793Long H, Pyakurel U, Wang Y, Liao L, Zhou Y, Lai W. Interventions for accelerating orthodontic tooth movement: a systematic review. Angle Orthod. 2013 Jan;83(1):164-71. doi: 10.2319/031512-224.1. Epub 2012 Jun 21.
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.
Wey Mang Check principal investigator
Faculty of Dentistry, University of Malaya
Jennifer Geraldine Doss principal investigator
Faculty of Dentistry, University of Malaya
Saritha Sivarajan principal investigator
Faculty of Dentistry, University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing micro-osteoperforation in people with Accelerated Tooth Movement Interval, run by University of Malaya 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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 30 Dec 2016. 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?
Results are not available in the source record.
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?
rate of orthodontic tooth movement between micro osteoperforated site and non micro-osteoperforated site. (time frame: through study completion, an average of 2 years). 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 NCT02571348, which also lists 6 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 30 Dec 2016.