- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05132764
Effect of Micro-osteo-perforations on the Rate of Alignment of Mandibular Anterior Teeth.
연구 개요
상세 설명
MATERIAL AND METHODS:
STUDY DESIGN: Two parallel arm randomized controlled clinical trial SETTING: Orthodontics Department, Rehman College of Dentistry. DURATION OF STUDY: one year SAMPLING TECHNIQUE: non-probability consecutive sampling.
SAMPLE SELECTION:
INCLUSION CRITERIA
- Malocclusion cases with mandibular anterior segment crowding.
- Age range 13-30 years.
EXCLUSION CRITERIA:
- Missing lower anterior tooth.
- Systemic diseases/Medications affecting bone biology.
- Previous orthodontic treatment.
- Poor oral hygiene status.
- Active periodontal disease
- Syndromes. DATA COLLECTION Written informed consent from the patients will be taken after clarification of the purpose of the intervention and the associated risks and benefits. Orthodontic treatment will be started in all subjects using fixed preadusted edgewise appliance (0.022-in MBT prescription, Ortho Organizers, Inc. USA). After bonding of lower arch the patients will be randomized into control and experimental groups.
Patients will be randomly allocated, through computer generated tables in Microsoft Excel Software, into parallel groups with a 1:1 allocation ratio. Allocation will be concealed in opaque envelopes and opened only at the time of intervention.
Local anesthesia will be given in lower arch on each side approximately 1cm from labial frenum. Two points for screw insertion will be demarcated on buccal mucosa, in each interdental segment, by bleeding points using a calibrated periodontal probe. Probe tip will be inserted to the level of bone to measure the thickness of gingiva. The measurement will be added to the depth of perforation needed i-e 2 - 3 mm into the bone. First point will be marked at a distance of 3mm from free gingival margin and second point will be marked 3mm from the first one. Orthodontic miniscrew (AbsoAnchor, Korea) of 1.3 mm diameter will be used for MOPs to the depth of 2-3 mm into the buccal cortical bone. An endodontic rubber stopper will be set for required / optimal depth on miniscrew and MOPs will be performed. After the intervention, the patients will be instructed for maintaining good oral hygiene and to take analgesics, such as acetaminophen, only if necessary.
The control group will receive no MOPs at the alignment stage. Alignment will be started in both control and experimental groups using 0.012 NiTi (North American Braces, USA). Both the groups will be followed every month for maximum six months. Digital scan of lower arch will be taken on each visit. Each scan will be labelled for identification, date of scan taking and little index score .For reliability 20 randomly selected scan will be rescored for little index by the same examiner as well as another examiner after 2 weeks for intra and inter-examiner reliability.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Shahida Jehan, BDS
- 전화번호: 03438901267
- 이메일: shahida.jehan@rmi.edu.pk
연구 연락처 백업
- 이름: Sohrab Shaheed, FCPS
- 전화번호: 03339327608
- 이메일: sohrab.shaheed@rmi.edu.pk
연구 장소
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KPK
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Peshawar, KPK, 파키스탄, 25100
- 모병
- Sohrab Shaheed
-
연락하다:
- Sohrab Shaheed, FCPS
- 전화번호: 03339327608
- 이메일: sohrab.shaheed@rmi.edu.pk
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Malocclusion cases with mandibular anterior segment crowding.
- Age range 13-30 years.
Exclusion Criteria:
- Missing lower anterior tooth.
- Systemic diseases/Medications affecting bone biology.
- Previous orthodontic treatment.
- Poor oral hygiene status.
- Active periodontal disease
- Syndromes
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: MOPs group
Orthodontic treatment will be started in all subjects using fixed preadusted edgewise appliance (0.022-in MBT prescription, Ortho Organizers, Inc. USA).Local anesthesia will be given in lower arch .Two points for screw insertion will be demarcated on buccal mucosa, in each interdental segment using a calibrated periodontal probe.
Orthodontic miniscrew (AbsoAnchor, Korea) of 1.3 mm diameter will be used for MOPs to the depth of 2-3 mm into the buccal cortical bone.
An endodontic rubber stopper will be set for required / optimal depth on miniscrew and MOPs will be performed.
After the intervention, the patients will be instructed for maintaining good oral hygiene and to take analgesics, such as acetaminophen, only if necessary.
|
2 inter radicular bone microosteoperforations using temporary anchorage device tip.
|
|
간섭 없음: Control group
Orthodontic treatment will be started in all subjects using fixed preadusted edgewise appliance (0.022-in MBT prescription, Ortho Organizers, Inc. USA).The control group will receive no MOPs at the alignment stage.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Rate of alignment of lower anterior teeth
기간: 6 months
|
Rate of alignment of lower anterior teeth
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6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
clinical crown length
기간: 6 moths
|
clinical crown length
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6 moths
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Muhammad K Asif, PhD, Rehman Medical Institute
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- EC : 2021-06-070
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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