Class III MalocclusionNCT05280678
Success Rate of the Miniscrews in the Mandibular Buccal Shelf
A study testing Orthodontic miniscrew insertion in the mandibular buccal shelf in people with Class III Malocclusion, run by Wroclaw Medical University.
Trial summary
Stability of the orthodontic miniscrews placed in the mandible is still considered to bare higher risk of failure compared to other intraoral locations. The aim of our study was to determine the influence of the miniscrew size on their long-term stability, occurrence of oral mucosa inflammation and pain lasting over… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Class III Malocclusion
- What is being tested?
- Orthodontic miniscrew insertion in the mandibular buccal shelf
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Jan 2019
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- generally healthy Caucasians
- mild Class III maloclussion that required an absolute anchorage for en-masse distalization in the mandible
- hypodivergent or normal angle between the maxillary and mandibular planes
- excellent oral hygiene
Who cannot join
- Hyperdivergent angle between the maxillary and mandibular planes
- unfavorable anatomical conditions - e.g. presence of a strong frenulum potentially irritating the miniscrew head during chewing and/or facial movement
About this study
Official title: Evidence-based Selection of Orthodontic Miniscrews, Increasing Their Success Rate in the Mandibular Buccal Shelf: A Randomized, Prospective Clinical Trial
Stability of the orthodontic miniscrews placed in the mandible is still considered to bare higher risk of failure compared to other intraoral locations. The aim of our study was to determine the influence of the miniscrew size on their long-term stability, occurrence of oral mucosa inflammation and pain lasting over 48 hours after implantation.
- Conditions
- Class III Malocclusion
- Being tested
- Orthodontic miniscrew insertion in the mandibular buccal shelf
- Keywords
- miniscrew, orthodontics, skeletal anchorage
- Medical subject headings
- Malocclusion, Angle Class III
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthodontic miniscrew insertion in the mandibular buccal shelfProcedure or surgery
Each patient received miniscrews in both sizes. The same orthodontist (M.S.) performed all the insertion procedures. Miniscrews were always placed in the mandibular buccal shelf, laterally to the first and second molar interproximal area, with angulation 30 degree to the bone surface, meaning that miniscrew angulation should be approximately the same as the axial inclination of the adjacent molar. Miniscrews were loaded with orthodontic force 2 weeks after the surgery. The investigated factors were:
- long-term success rate of the miniscrews in the buccal shelf of the mandible (miniscrews were considered long-term stable if they served as an anchorage until completion of mandibular distalization, at least 9 months);
- peri-implantitis development (enlargement of the gingiva and/or redness and/or tendency to bleed);
- the patient's report of pain lasting longer than 48 hours after miniscrew insertion.
| Study group | Role | What they receive |
|---|---|---|
| SH2018-10 miniscrew side | Experimental | We designed our project as a split-mouth study, therefore each patient received both SH2018-10 and SH1514-08 miniscrews, randomly assigned to either left or right side. To do so, our nurse divided both miniscrew types into two halves and assigned symbols appropriate for blinding the intervention. Thus, two combinations of miniscrew sets aroused: 1. SH1514-08R and SH2018-10L or 2. SH1514-08L and SH2018-10R, which were placed separately in opaque packages marked consecutively from "1" to "100" and stored on the tray with dividers. One hundred cards, labeled accordingly, were placed in an envelope, from which the nurse blindly pulled the card just before the miniscrew insertion, this way assigning the set number to every patient. Thus both: the placement side and the screw size were random for clinician. Receives: Procedure: Orthodontic miniscrew insertion in the mandibular buccal shelf |
| SH1514-08 miniscrew side | Experimental | We designed our project as a split-mouth study, therefore each patient received both SH2018-10 and SH1514-08 miniscrews, randomly assigned to either left or right side. To do so, our nurse divided both miniscrew types into two halves and assigned symbols appropriate for blinding the intervention. Thus, two combinations of miniscrew sets aroused: 1. SH1514-08R and SH2018-10L or 2. SH1514-08L and SH2018-10R, which were placed separately in opaque packages marked consecutively from "1" to "100" and stored on the tray with dividers. One hundred cards, labeled accordingly, were placed in an envelope, from which the nurse blindly pulled the card just before the miniscrew insertion, this way assigning the set number to every patient. Thus both: the placement side and the screw size were random for clinician. Receives: Procedure: Orthodontic miniscrew insertion in the mandibular buccal shelf |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: The first evaluation was performed 2 weeks after miniscrew insertion and then every 4-6 weeks (at follow-up visits) throughout the duration of distalization (up to 2 years).
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 first evaluation was performed 2 weeks after miniscrew insertion and then every 4-6 weeks (at follow-up visits) throughout the duration of distalization (up to 2 years).
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: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study startJan 2016
- Primary completionJan 2019
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Class III MalocclusionStudies 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
- 200 Absoanchor® miniscrews (Dentos, South Korea) in two sizes: SH2018-10 (length 10 mm, ø 18-20 mm) and SH1514-08 (length 8 mm, ø 14-15 mm) were inserted in the mandibular buccal shelf of 100 Caucasians aged 20-50 years, diagnosed with Class III malocclusion that required en-masse distalization of the mandibular dentition. We designed our project as a split-mouth study, therefore each patient received both SH2018-10 and SH1514-08 miniscrews. The same orthodontist (M.S.) inserted the screws near the muco-gingival junction, following one surgical protocol. Miniscrews were loaded with orthodontic force (NiTi coil springs) of approximately 200 g, two weeks after the surgery. On the same visit patients were surveyed upon pain incidence lasting longer than 48 hours. Then TISAD stability and soft tissue condition were closely examined at each appointment. Miniscrews were considered long-term stable if they served as an anchorage until completion of distalization of the mandibular teeth.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wroclaw Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michał Sarul, Wroclaw Medical University
- Investigators
- Michał Sarul, Principal investigator, Wroclaw Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05280678
- Sponsor's protocol ID
- 293/2007
- Status last verified
- Mar 2022
- First submitted
- 10 Jan 2022
- Last updated
- 15 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sarul M, Lis J, Park HS, Rumin K. Evidence-based selection of orthodontic miniscrews, increasing their success rate in the mandibular buccal shelf. A randomized, prospective clinical trial. BMC Oral Health. 2022 Sep 20;22(1):414. doi: 10.1186/s12903-022-02460-3.
PubMed 36127718
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evidence-based Selection of Orthodontic Miniscrews, Increasing Their Success Rate in the Mandibular Buccal Shelf: A Randomized, Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT05280678
- Acronym / sponsor ID
- 293/2007
- Conditions
- Class III Malocclusion
- Keywords
- miniscrew, orthodontics, skeletal anchorage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Wroclaw Medical UniversityUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 15 Mar 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.
Stability of the orthodontic miniscrews placed in the mandible is still considered to bare higher risk of failure compared to other intraoral locations. The aim of our study was to determine the influence of the miniscrew size on their long-term stability, occurrence of oral mucosa inflammation and pain lasting over 48 hours after implantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 200 Absoanchor® miniscrews (Dentos, South Korea) in two sizes: SH2018-10 (length 10 mm, ø 18-20 mm) and SH1514-08 (length 8 mm, ø 14-15 mm) were inserted in the mandibular buccal shelf of 100 Caucasians aged 20-50 years, diagnosed with Class III malocclusion that required en-masse distalization of the mandibular dentition. We designed our project as a split-mouth study, therefore each patient received both SH2018-10 and SH1514-08 miniscrews. The same orthodontist (M.S.) inserted the screws near the muco-gingival junction, following one surgical protocol. Miniscrews were loaded with orthodontic force (NiTi coil springs) of approximately 200 g, two weeks after the surgery. On the same visit patients were surveyed upon pain incidence lasting longer than 48 hours. Then TISAD stability and soft tissue condition were closely examined at each appointment. Miniscrews were considered long-term stable if they served as an anchorage until completion of distalization of the mandibular teeth.
| Arm | Type | Receives |
|---|---|---|
| SH2018-10 miniscrew side | Experimental | Procedure: Orthodontic miniscrew insertion in the mandibular buccal shelfWe designed our project as a split-mouth study, therefore each patient received both SH2018-10 and SH1514-08 miniscrews, randomly assigned to either left or right side. To do so, our nurse divided both miniscrew types into two halves and assigned symbols appropriate for blinding the intervention. Thus, two combinations of miniscrew sets aroused: 1. SH1514-08R and SH2018-10L or 2. SH1514-08L and SH2018-10R, which were placed separately in opaque packages marked consecutively from "1" to "100" and stored on the tray with dividers. One hundred cards, labeled accordingly, were placed in an envelope, from which the nurse blindly pulled the card just before the miniscrew insertion, this way assigning the set number to every patient. Thus both: the placement side and the screw size were random for clinician. |
| SH1514-08 miniscrew side | Experimental | Procedure: Orthodontic miniscrew insertion in the mandibular buccal shelfWe designed our project as a split-mouth study, therefore each patient received both SH2018-10 and SH1514-08 miniscrews, randomly assigned to either left or right side. To do so, our nurse divided both miniscrew types into two halves and assigned symbols appropriate for blinding the intervention. Thus, two combinations of miniscrew sets aroused: 1. SH1514-08R and SH2018-10L or 2. SH1514-08L and SH2018-10R, which were placed separately in opaque packages marked consecutively from "1" to "100" and stored on the tray with dividers. One hundred cards, labeled accordingly, were placed in an envelope, from which the nurse blindly pulled the card just before the miniscrew insertion, this way assigning the set number to every patient. Thus both: the placement side and the screw size were random for clinician. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- generally healthy Caucasians
- mild Class III maloclussion that required an absolute anchorage for en-masse distalization in the mandible
- hypodivergent or normal angle between the maxillary and mandibular planes
- excellent oral hygiene
Key exclusion criteria (2 listed)
- Hyperdivergent angle between the maxillary and mandibular planes
- unfavorable anatomical conditions - e.g. presence of a strong frenulum potentially irritating the miniscrew head during chewing and/or facial movement
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 in the mandibular buccal shelfEach patient received miniscrews in both sizes. The same orthodontist (M.S.) performed all the insertion procedures. Miniscrews were always placed in the mandibular buccal shelf, laterally to the first and second molar interproximal area, with angulation 30 degree to the bone surface, meaning that miniscrew angulation should be approximately the same as the axial inclination of the adjacent molar. Miniscrews were loaded with orthodontic force 2 weeks after the surgery. The investigated factors were: * long-term success rate of the miniscrews in the buccal shelf of the mandible (miniscrews were considered long-term stable if they served as an anchorage until completion of mandibular distalization, at least 9 months); * peri-implantitis development (enlargement of the gingiva and/or redness and/or tendency to bleed); * the patient's report of pain lasting longer than 48 hours after miniscrew insertion. | Procedure or surgery | SH1514-08 miniscrew side, SH2018-10 miniscrew side |
Primary outcome
Assessing the stability of miniscrews
Time frame: The first evaluation was performed 2 weeks after miniscrew insertion and then every 4-6 weeks (at follow-up visits) throughout the duration of distalization (up to 2 years).
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.
Assessing the presence of peri-implantitis
Time frame: The first evaluation was performed 2 weeks after miniscrew insertion and then every 4-6 weeks (at follow-up visits) throughout the duration of distalization (up to 2 years).
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: two weeks
Two weeks after the miniscrew implantation patients were surveyed upon pain incidence lasting longer than 48 hours.
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 15 Mar 2022.
- Derived from this study: PubMed 36127718Sarul M, Lis J, Park HS, Rumin K. Evidence-based selection of orthodontic miniscrews, increasing their success rate in the mandibular buccal shelf. A randomized, prospective clinical trial. BMC Oral Health. 2022 Sep 20;22(1):414. doi: 10.1186/s12903-022-02460-3.
- 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.
Michał Sarul principal investigator
Wroclaw Medical University
Questions about this trial
What is this clinical trial studying?
A study testing Orthodontic miniscrew insertion in the mandibular buccal shelf in people with Class III Malocclusion, 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 4 inclusion and 2 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 15 Mar 2022. 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 stability of miniscrews (time frame: The first evaluation was performed 2 weeks after miniscrew insertion and then every 4-6 weeks (at follow-up visits) throughout the duration of distalization (up to 2 years).). The study lists 3 primary outcomes in all. 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 NCT05280678, which also lists 1 linked publication.
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 15 Mar 2022.