Clinical trial NCT05280678: Success Rate of the Miniscrews in the Mandibular Buccal Shelf
Official title: Evidence-based Selection of Orthodontic Miniscrews, Increasing Their Success Rate in the Mandibular Buccal Shelf: A Randomized, Prospective Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Class III Malocclusion
Keywords: miniscrew
orthodontics
skeletal anchorage
Lead sponsor: Wroclaw Medical University
Sponsor class: OTHER
First posted: 2022-03-15
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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 48 hours after implantation.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Assessing the stability of miniscrews
timeFrame: 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).
measure: Assessing the presence of peri-implantitis
timeFrame: 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).
measure: Assessing the presence of pain lasting longer than 48 hours after implantation.
timeFrame: two weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wroclaw Medical University
name: Michał Sarul
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.