Risk Factors Favourable to Promote Intra- and Postsurgical Complications Accompanying Microscrew Insertion for Distalisation of Maxillary Dentition
2026년 8월 10일 업데이트: Wroclaw Medical University
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.
연구 개요
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연구 유형
중재적
등록 (실제)
1008
단계
- 해당 없음
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예
설명
Inclusion Criteria:
- Patients between 20 and 40 y.o. with indication for microimplant insertion in the maxilla to reinforce anchorage during en bloc distalisation.
Exclusion Criteria:
- Smoking,
- Inadequate oral hygiene
- Chronic diseases (e.g. diabetes)
- Tooth loss
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
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디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Insertion with self-drilling technique
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.
|
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:
|
|
실험적: Insertion with self-tapping technique
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.
|
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:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Assessing the presence of peri-implantitis
기간: 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).
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Hypertrophy of the gingiva and/or redness and/or tendency to bleed was noted as the inflammation presence.
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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).
|
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Assessing the presence of pain lasting longer than 48 hours after implantation.
기간: 2 weeks after implantation
|
Two weeks after the miniscrew implantation patients were surveyed upon pain incidence lasting longer than 48 hours.
|
2 weeks after implantation
|
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Assessing the presence of root perforation
기간: Immediately after implantation
|
Root perforation was diagnosed in CBCT performed after the procedure.
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Immediately after implantation
|
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Assesing the presence of microimplant fracture
기간: During implantation
|
Microimplant fracture was diagnosed during implantation, reported by the clinician.
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During implantation
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Assessing the stability of miniscrews
기간: During subsequent follow-up visits, until the distalization was completed, assessed up to 12 months.
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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.
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During subsequent follow-up visits, until the distalization was completed, assessed up to 12 months.
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이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2015년 1월 1일
기본 완료 (실제)
2024년 3월 31일
연구 완료 (실제)
2024년 5월 14일
연구 등록 날짜
최초 제출
2026년 7월 21일
QC 기준을 충족하는 최초 제출
2026년 8월 10일
처음 게시됨 (실제)
2026년 8월 12일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 12일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 10일
마지막으로 확인됨
2024년 6월 1일
추가 정보
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키워드
기타 연구 ID 번호
- SUBZ.B190.24.005
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