Malocclusion Class IINCT07761494
Risk Factors Favourable to Promote Intra- and Postsurgical Complications Accompanying Microscrew Insertion for Distalisation of Maxillary Dentition
A study testing Orthodontic miniscrew insertion using self-drilling method and Orthodontic miniscrew insertion using self-tapping method in people with Malocclusion Class II, run by Wroclaw Medical University.
Trial summary
Evidence for the undeniable role of microscrews in anchorage control, as well as their other advantages, such as ease of insertion and removal techniques, have led to their routine use in orthodontics. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Malocclusion Class II
- What is being tested?
- Orthodontic miniscrew insertion using self-drilling method and Orthodontic miniscrew insertion using self-tapping method
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,008 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 14 May 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients between 20 and 40 y.o. with indication for microimplant insertion in the maxilla to reinforce anchorage during en bloc distalisation.
Who cannot join
- Smoking,
- Inadequate oral hygiene
- Chronic diseases (e.g. diabetes)
- Tooth loss
About this study
Official title: Risk Factors Favourable to Promote Intra- and Postsurgical Complications Accompanying Microscrew Insertion for Distalisation of Maxillary Dentition. Randomised Control Study
Evidence for the undeniable role of microscrews in anchorage control, as well as their other advantages, such as ease of insertion and removal techniques, have led to their routine use in orthodontics. Treatment with microscrews, despite its obvious advantages, is associated with the risk of complications, the etiology of which is multifactorial. Identifying (and subsequently controlling) as many of them as possible through research constitutes an ongoing challenge for scientists. This pursuit defined the purpose of the present study: to determine whether a type of TISAD insertion technique - self-drilling or self-tapping - as well as the patient's sex and maxillary quadrant constitute predisposing factors for the occurrence of certain complications.
- Conditions
- Malocclusion Class II
- Being tested
- Orthodontic miniscrew insertion using self-drilling method, Orthodontic miniscrew insertion using self-tapping method
- Keywords
- skeletal anchorage, microscrews, orthodontic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthodontic miniscrew insertion using self-drilling methodProcedure or surgery
Patients received 2 miniscrews using self-drilling method. The same orthodontist (M.S.) performed all the insertion procedures. Miniscrews were always placed at the junction of the attached mucosa and alveolar gingiva, between teeth 15 and 16, and between teeth 25 and 26, in accordance with the Wrocław protocol guidelines. The investigated complications were:
- peri-implantitis development ;
- the patient's report of pain lasting longer than 48 hours after miniscrew insertion.
- occurence of rooth perforation diagnosed in CBCT performed after procedure
- occurence of microimplant fracture during procedure
- microimplant failure recorded during subsequent follow-up visits.
Orthodontic miniscrew insertion using self-tapping methodProcedure or surgery
Patients received 2 miniscrews using self-tapping method. The same orthodontist (M.S.) performed all the insertion procedures. Miniscrews were always placed at the junction of the attached mucosa and alveolar gingiva, between teeth 15 and 16, and between teeth 25 and 26, in accordance with the Wrocław protocol guidelines. The investigated factors were:
- peri-implantitis development ;
- the patient's report of pain lasting longer than 48 hours after miniscrew -insertion.
- occurence of rooth perforation diagnosed in CBCT performed after procedure
- occurence of microimplant fracture during procedure microimplant failure recorded during subsequent follow-up visits.
| Study group | Role | What they receive |
|---|---|---|
| Insertion with self-drilling technique | Experimental | Each patient received two microimplants both using self- drilling method. In accordance with the principles of a randomized controlled trial, the choice between the self-drilling and self-tapping techniques was alternated between patients by a flip of a coin performed by a dental assistant. Receives: Procedure: Orthodontic miniscrew insertion using self-drilling method |
| Insertion with self-tapping technique | Experimental | Each patient received two microimplants both using self-tapping method. In accordance with the principles of a randomized controlled trial, the choice between the self-drilling and self-tapping techniques was alternated between patients by a flip of a coin performed by a dental assistant. Receives: Procedure: Orthodontic miniscrew insertion using self-tapping method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing the presence of peri-implantitis
Hypertrophy of the gingiva and/or redness and/or tendency to bleed was noted as the inflammation presence.
Measured: The occurrence of inflammation was recorded during subsequent follow-up visits (first 2 weeks after implantation and then every 6 weeks, until the distalization was completed, assessed up to 12 months).
Assessing the presence of pain lasting longer than 48 hours after implantation.
Two weeks after the miniscrew implantation patients were surveyed upon pain incidence lasting longer than 48 hours.
Measured: 2 weeks after implantation
Assessing the presence of root perforation
Root perforation was diagnosed in CBCT performed after the procedure.
Measured: Immediately after implantation
Assesing the presence of microimplant fracture
Microimplant fracture was diagnosed during implantation, reported by the clinician.
Measured: During implantation
Assessing the stability of miniscrews
The mobility of the miniscrews was checked clinically with cotton tweezers at each visit. Miniscrews that could not sustain orthodontic force and required replacement because of mobility were considered failures.
Measured: During subsequent follow-up visits, until the distalization was completed, assessed up to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start1 Jan 2015
- Primary completion31 Mar 2024
- Study completion14 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malocclusion Class IIStudies 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
- 1,008 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wroclaw Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07761494
- Sponsor's protocol ID
- SUBZ.B190.24.005
- Status last verified
- Jun 2024
- First submitted
- 21 Jul 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors Favourable to Promote Intra- and Postsurgical Complications Accompanying Microscrew Insertion for Distalisation of Maxillary Dentition. Randomised Control Study
- ClinicalTrials.gov ID
- NCT07761494
- Acronym / sponsor ID
- SUBZ.B190.24.005
- Conditions
- Malocclusion Class II
- Keywords
- skeletal anchorage, microscrews, orthodontic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,008 participants (actual)
- Lead sponsor
- Wroclaw Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 14 May 2024 (actual)
- First posted
- 12 Aug 2026 (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.
Evidence for the undeniable role of microscrews in anchorage control, as well as their other advantages, such as ease of insertion and removal techniques, have led to their routine use in orthodontics. Treatment with microscrews, despite its obvious advantages, is associated with the risk of complications, the etiology of which is multifactorial. Identifying (and subsequently controlling) as many of them as possible through research constitutes an ongoing challenge for scientists. This pursuit defined the purpose of the present study: to determine whether a type of TISAD insertion technique - self-drilling or self-tapping - as well as the patient's sex and maxillary quadrant constitute predisposing factors for the occurrence of certain complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insertion with self-drilling technique | Experimental | Procedure: Orthodontic miniscrew insertion using self-drilling methodEach patient received two microimplants both using self- drilling method. In accordance with the principles of a randomized controlled trial, the choice between the self-drilling and self-tapping techniques was alternated between patients by a flip of a coin performed by a dental assistant. |
| Insertion with self-tapping technique | Experimental | Procedure: Orthodontic miniscrew insertion using self-tapping methodEach patient received two microimplants both using self-tapping method. In accordance with the principles of a randomized controlled trial, the choice between the self-drilling and self-tapping techniques was alternated between patients by a flip of a coin performed by a dental assistant. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients between 20 and 40 y.o. with indication for microimplant insertion in the maxilla to reinforce anchorage during en bloc distalisation.
Key exclusion criteria (4 listed)
- Smoking,
- Inadequate oral hygiene
- Chronic diseases (e.g. diabetes)
- Tooth 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 |
|---|---|---|
| Orthodontic miniscrew insertion using self-drilling methodPatients received 2 miniscrews using self-drilling method. The same orthodontist (M.S.) performed all the insertion procedures. Miniscrews were always placed at the junction of the attached mucosa and alveolar gingiva, between teeth 15 and 16, and between teeth 25 and 26, in accordance with the Wrocław protocol guidelines. The investigated complications were: * peri-implantitis development ; * the patient's report of pain lasting longer than 48 hours after miniscrew insertion. * occurence of rooth perforation diagnosed in CBCT performed after procedure * occurence of microimplant fracture during procedure * microimplant failure recorded during subsequent follow-up visits. | Procedure or surgery | Insertion with self-drilling technique |
| Orthodontic miniscrew insertion using self-tapping methodPatients received 2 miniscrews using self-tapping method. The same orthodontist (M.S.) performed all the insertion procedures. Miniscrews were always placed at the junction of the attached mucosa and alveolar gingiva, between teeth 15 and 16, and between teeth 25 and 26, in accordance with the Wrocław protocol guidelines. The investigated factors were: * peri-implantitis development ; * the patient's report of pain lasting longer than 48 hours after miniscrew -insertion. * occurence of rooth perforation diagnosed in CBCT performed after procedure * occurence of microimplant fracture during procedure microimplant failure recorded during subsequent follow-up visits. | Procedure or surgery | Insertion with self-tapping technique |
Primary outcome
Assessing the presence of peri-implantitis
Time frame: The occurrence of inflammation was recorded during subsequent follow-up visits (first 2 weeks after implantation and then every 6 weeks, until the distalization was completed, assessed up to 12 months).
Hypertrophy of the gingiva and/or redness and/or tendency to bleed was noted as the inflammation presence.
Assessing the presence of pain lasting longer than 48 hours after implantation.
Time frame: 2 weeks after implantation
Two weeks after the miniscrew implantation patients were surveyed upon pain incidence lasting longer than 48 hours.
Assessing the presence of root perforation
Time frame: Immediately after implantation
Root perforation was diagnosed in CBCT performed after the procedure.
Assesing the presence of microimplant fracture
Time frame: During implantation
Microimplant fracture was diagnosed during implantation, reported by the clinician.
Assessing the stability of miniscrews
Time frame: During subsequent follow-up visits, until the distalization was completed, assessed up to 12 months.
The mobility of the miniscrews was checked clinically with cotton tweezers at each visit. Miniscrews that could not sustain orthodontic force and required replacement because of mobility were considered failures.
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 12 Aug 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Orthodontic miniscrew insertion using self-drilling method and Orthodontic miniscrew insertion using self-tapping method in people with Malocclusion Class II, run by Wroclaw Medical University.
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 1 inclusion and 4 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 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Assessing the presence of peri-implantitis (time frame: The occurrence of inflammation was recorded during subsequent follow-up visits (first 2 weeks after implantation and then every 6 weeks, until the distalization was completed, assessed up to 12 months).). The study lists 5 primary outcomes in all. 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 12 Aug 2026.