Tooth Movement TechniquesNCT05339620
Effect of Implant Driver Facilitated Micro-osteo Perforation on the Rate of Tooth Movement.
A study testing implant driver facilitated micro-osteoperforations in people with Tooth Movement Techniques, run by Bahria University at 1 site in Pakistan.
Trial summary
we have conducted a split-mouth randomized clinical trial to study effects of implant induced micro-osteoperforations on the rate of tooth movement during canine retraction. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Tooth Movement Techniques
- What is being tested?
- implant driver facilitated micro-osteoperforations
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 sitePakistan
- Study dates
- 7 Jan 2018to 20 Mar 2022
- 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
- No healthy volunteers
- Adult
Who may be able to join
- • Male and female
- Age 18- 45 years
- Class 2 div 1
- No systemic disease
- No radiographic evidence of bone loss
- No history of periodontal therapy
Show all 12Show fewer
- No current active periodontal disease
- No smoking
- No gingivitis or untreated caries
- Probing depth < 4mm in all teeth
- Gingival index < 1mm
- Plaque index < 1mm
Who cannot join
- Long term use of antibiotics, phenytoin,cyclosporine, anti inflammatory drugs, systemic corticosteroids and calcium channel blockers.
- Poor oral hygiene for more than 2 visits.
- Extreme skeletal class 2 malocclusion, overjet > 10mm, anb> 7
- Systemic disease
- Evidence of bone loss
- Past periodontal disease
Show all 10Show fewer
- Current periodontal disease
- Smoking
- Gingivitis and caries
- Probing depth > 4mm
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Bahria University Medical and Dental College
Karachi, Sindh, 75200
About this study
Official title: Effect of Implant Driver Facilitated Micro-osteo Perforations on the Rate of Tooth Movement.
we have conducted a split-mouth randomized clinical trial to study effects of implant induced micro-osteoperforations on the rate of tooth movement during canine retraction.
Read the detailed description
The experimental group will receive implant driver facilitated microosteoperforation on one side of the mouth( according to split mouth design) decided by random allocation.
After 3 months of extraction of upper first premolar ( according to planned orthodontic treatment), 3 microosteoperforation will be done with implant in an implant driver distal to canine. Surgical procedure will be done in local anesthesia, no flap will be raised. Alginate impressions will be taken before the procedure and 28 days after canine retraction has started, to measure the difference between rate of canine retraction on both sides. Measurement was done by a digital vernier caliper,
- Conditions
- Tooth Movement Techniques
- Being tested
- implant driver facilitated micro-osteoperforations
- Keywords
- micro-osteoperforations, tooth movement, implant driver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implant driver facilitated micro-osteoperforationsProcedure or surgery
Also called micro-osteoperforations by any other means.
3 micro-osteoperforations(in a vertical pattern) are done on the randomly allocated experimental side , distal to canine under local anesthesia. the other side of the mouth is used as a control.
alginate impression is taken before the intervention .
| Study group | Role | What they receive |
|---|---|---|
| mop group | Experimental | a group of patients with a class 2 divsion 1 dental malocclusion, overjet greater than 9 mm, extraction of upper first premolars planned, and it has been 3 months post extraction and before canine retraction is commenced. Receives: Procedure: implant driver facilitated micro-osteoperforations |
| mop group ( same) | Active comparator | a group of patients with a class 2 divsion 1 dental malocclusion, overjet greater than 9 mm, extraction of upper first premolars planned, and it has been 3 months post extraction and before canine retraction is commenced. Receives: Procedure: implant driver facilitated micro-osteoperforations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing rate of canine retraction between intervention and non-intervention side.
distance from cusp tip of canine to mesio-buccal cusp tip of molar taken by digital vernier caliper.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start7 Jan 2018
- Primary completion15 Jan 2022
- Study completion20 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Tooth Movement TechniquesStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DR MARIA HABIB, Bahria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05339620
- Sponsor's protocol ID
- ERC 05/2018
- Status last verified
- Apr 2022
- First submitted
- 15 Apr 2022
- Last updated
- 21 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cheung T, Park J, Lee D, Kim C, Olson J, Javadi S, Lawson G, McCabe J, Moon W, Ting K, Hong C. Ability of mini-implant-facilitated micro-osteoperforations to accelerate tooth movement in rats. Am J Orthod Dentofacial Orthop. 2016 Dec;150(6):958-967. doi: 10.1016/j.ajodo.2016.04.030.
PubMed 27894545Ozkan TH, Arici S. The effect of different micro-osteoperforation depths on the rate of orthodontic tooth movement: A single-center, single-blind, randomized clinical trial. Korean J Orthod. 2021 May 25;51(3):157-165. doi: 10.4041/kjod.2021.51.3.157.
PubMed 33984223Aboalnaga AA, Salah Fayed MM, El-Ashmawi NA, Soliman SA. Effect of micro-osteoperforation on the rate of canine retraction: a split-mouth randomized controlled trial. Prog Orthod. 2019 Jun 3;20(1):21. doi: 10.1186/s40510-019-0274-0.
PubMed 31155698Bolat Gumus E, Kinsiz E. Effects of miniscrew-facilitated micro-osteoperforations on the rate of orthodontic tooth movement : A split-mouth, randomized controlled trial. J Orofac Orthop. 2023 Apr;84(Suppl 2):104-110. doi: 10.1007/s00056-021-00371-6. Epub 2022 Jan 13.
PubMed 35024875
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Implant Driver Facilitated Micro-osteo Perforations on the Rate of Tooth Movement.
- ClinicalTrials.gov ID
- NCT05339620
- Acronym / sponsor ID
- ERC 05/2018
- Conditions
- Tooth Movement Techniques
- Keywords
- micro-osteoperforations, tooth movement, implant driver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Bahria UniversityUniversity, hospital or other
- Study start
- 7 Jan 2018 (actual)
- Primary completion
- 15 Jan 2022 (actual)
- Study completion
- 20 Mar 2022 (actual)
- First posted
- 21 Apr 2022 (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.
we have conducted a split-mouth randomized clinical trial to study effects of implant induced micro-osteoperforations on the rate of tooth movement during canine retraction.
Detailed description
The experimental group will receive implant driver facilitated microosteoperforation on one side of the mouth( according to split mouth design) decided by random allocation.
After 3 months of extraction of upper first premolar ( according to planned orthodontic treatment), 3 microosteoperforation will be done with implant in an implant driver distal to canine. Surgical procedure will be done in local anesthesia, no flap will be raised. Alginate impressions will be taken before the procedure and 28 days after canine retraction has started, to measure the difference between rate of canine retraction on both sides. Measurement was done by a digital vernier caliper,
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mop group | Experimental | Procedure: implant driver facilitated micro-osteoperforationsa group of patients with a class 2 divsion 1 dental malocclusion, overjet greater than 9 mm, extraction of upper first premolars planned, and it has been 3 months post extraction and before canine retraction is commenced. |
| mop group ( same) | Active comparator | Procedure: implant driver facilitated micro-osteoperforationsa group of patients with a class 2 divsion 1 dental malocclusion, overjet greater than 9 mm, extraction of upper first premolars planned, and it has been 3 months post extraction and before canine retraction is commenced. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- • Male and female
Key exclusion criteria (10 listed)
- Long term use of antibiotics, phenytoin,cyclosporine, anti inflammatory drugs, systemic corticosteroids and calcium channel blockers.
- Poor oral hygiene for more than 2 visits.
- Extreme skeletal class 2 malocclusion, overjet > 10mm, anb> 7
- Systemic disease
- Evidence of bone loss
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 |
|---|---|---|
| implant driver facilitated micro-osteoperforationsAlso: micro-osteoperforations by any other means.3 micro-osteoperforations(in a vertical pattern) are done on the randomly allocated experimental side , distal to canine under local anesthesia. the other side of the mouth is used as a control. alginate impression is taken before the intervention . | Procedure or surgery | mop group, mop group ( same) |
Primary outcome
Comparing rate of canine retraction between intervention and non-intervention side.
Time frame: 28 days
distance from cusp tip of canine to mesio-buccal cusp tip of molar taken by digital vernier caliper.
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 21 Apr 2022.
- Background: PubMed 27894545Cheung T, Park J, Lee D, Kim C, Olson J, Javadi S, Lawson G, McCabe J, Moon W, Ting K, Hong C. Ability of mini-implant-facilitated micro-osteoperforations to accelerate tooth movement in rats. Am J Orthod Dentofacial Orthop. 2016 Dec;150(6):958-967. doi: 10.1016/j.ajodo.2016.04.030.
- Background: PubMed 33984223Ozkan TH, Arici S. The effect of different micro-osteoperforation depths on the rate of orthodontic tooth movement: A single-center, single-blind, randomized clinical trial. Korean J Orthod. 2021 May 25;51(3):157-165. doi: 10.4041/kjod.2021.51.3.157.
- Background: PubMed 31155698Aboalnaga AA, Salah Fayed MM, El-Ashmawi NA, Soliman SA. Effect of micro-osteoperforation on the rate of canine retraction: a split-mouth randomized controlled trial. Prog Orthod. 2019 Jun 3;20(1):21. doi: 10.1186/s40510-019-0274-0.
- Background: PubMed 35024875Bolat Gumus E, Kinsiz E. Effects of miniscrew-facilitated micro-osteoperforations on the rate of orthodontic tooth movement : A split-mouth, randomized controlled trial. J Orofac Orthop. 2023 Apr;84(Suppl 2):104-110. doi: 10.1007/s00056-021-00371-6. Epub 2022 Jan 13.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing implant driver facilitated micro-osteoperforations in people with Tooth Movement Techniques, run by Bahria University at 1 site in Pakistan.
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 12 inclusion and 10 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 21 Apr 2022. 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 Pakistan. 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?
Comparing rate of canine retraction between intervention and non-intervention side. (time frame: 28 days). 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 NCT05339620, which also lists 4 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 21 Apr 2022.