Evaluation of the Levels of Pain and Discomfort Between Two Methods of Leveling and Alignment
2020년 4월 15일 업데이트: Damascus University
The Effect of Corticision on Perceived Pain and Discomfort for Patients With Crowded Lower Anterior Teeth: Randomized Clinical Trial
The duration of orthodontic treatment is one of the exacerbation causes of orthodontic pain. Several methods have been suggested to reduce the duration of orthodontic treatment classified to surgical and non-surgical methods.
Researches used minimally invasive surgical methods like corticision, piezocesion, micro-osteoperforation, and piezo-puncture indicated that most of these methods can accelerate dental movement by 20 - 40% without causing additional pain as a result of using those methods. Applying corticision on the lower anterior teeth using a surgical blade and a hammer may accelerate tooth alignment during orthodontic treatment. This study consists of two groups, patients will be randomly assigned to one of these two groups.
연구 개요
상세 설명
Pain is defined as an unpleasant emotional sensory experience associated with actual or potential harm. It was mentioned as one of the most common complaints related to orthodontic treatment, and around 65-95% of patients undergoing orthodontic treatment suffer from various degrees of pain.
Corticision is one of the minimally invasive surgical procedures that is not associated with flap lifting. It was used to accelerate tooth movement in animals and case report studies. Its application on humans may aggravate their fear and anxiety towards the pain that may accompany this technique.
No study in the literature has been searched in patient perception of pain, discomfort, levels of acceptance and satisfaction accompanied corticision application, but in this study, these previous variables accompanied corticision technique have been studied on crowded lower anterior teeth cases which are one of the most common types of malocclusion.
연구 유형
중재적
등록 (실제)
26
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Damascus, 시리아 아랍 공화국, 00963
- Orthodontic Department, University of Damascus Dental School
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Age range between 18 and 24 years
- Completion permanent dentition (except third molars)
- Mild to moderate crowding (2-6 mm according to Little's index)
- Absence of medications intake that interferes with pain perception for at least one week before the beginning of the treatment
Exclusion Criteria:
- Systematic diseases that could affect bone and tooth movement and no contraindication avoid oral surgery
- Medical conditions that affect tooth movement (Corticosteroid, NSAIDs)
- Patients had previous orthodontic treatments
- Poor oral hygiene or concurrent periodontal disease
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Corticision
Patients will undergo a corticision procedure in order to accelerate tooth movement
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Surgical intervention is going to be used in the interdental areas between the lower anterior teeth to accelerate tooth movement.
Three incisions are going to be made
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활성 비교기: Traditional treatment
Patients will undergo traditional orthodontic treatment without any surgical intervention.
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No surgical intervention will be used, just normal orthodontic sequence of procedures.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in the Perception of Pain
기간: At 24 hours following the onset of treatment (bonding of the appliance), then at 7 days, 14 days following the onset of orthodontic treatment
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Pain is assessed by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of pain being experienced.
The left end of the line refers to no pain (VAS=0) where the right end refers to maximum (unimaginable) pain (VAS=100).
The level of pain is represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient.
This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the pain.
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At 24 hours following the onset of treatment (bonding of the appliance), then at 7 days, 14 days following the onset of orthodontic treatment
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Change in the Perception of Discomfort
기간: At 24 hours following the onset of treatment (bonding of the appliance), then at 7 days, 14 days following the onset of orthodontic treatment
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Discomfort is assessed by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of discomfort being experienced.
The left end of the line refers to no discomfort (VAS=0) where the right end refers to maximum discomfort (VAS=100).
The level of discomfort is represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient.
This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the discomfort.
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At 24 hours following the onset of treatment (bonding of the appliance), then at 7 days, 14 days following the onset of orthodontic treatment
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Change in the Perception of Swelling
기간: At 24 hours following the onset of treatment (bonding of the appliance), then at 7 days, 14 days following the onset of orthodontic treatment
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Swelling is assessed by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of swelling being experienced.
The left end of the line refers to no swelling (VAS=0) where the right end refers to maximum swelling (VAS=100).
The level of swelling is represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient.
This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the swelling
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At 24 hours following the onset of treatment (bonding of the appliance), then at 7 days, 14 days following the onset of orthodontic treatment
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Change in the Levels of Difficulties in Mastication
기간: At 24 hours following the onset of treatment (bonding of the appliance), then at 7 days, 14 days following the onset of orthodontic treatment
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Difficulties of mastication are assessed by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of difficulties in mastication being experienced.
The left end of the line refers to no difficulties (VAS=0) where the right end refers to maximum difficulties (VAS=100).
The level of difficulties in mastication is represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient.
This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the difficulties of mastication.
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At 24 hours following the onset of treatment (bonding of the appliance), then at 7 days, 14 days following the onset of orthodontic treatment
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Analgesic Consumption
기간: The 7th day following the onset of treatment (i.e. at the second visit of the patients following his orthodontic appliance bonding; one-time assessment)
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Patients in both groups were asked about taking analgesics and their quantity (mg) They answered about taking analgesics using a two-point scale (1.
Yes or 2. No), and their quantity by mentioning how many tablets they took.
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The 7th day following the onset of treatment (i.e. at the second visit of the patients following his orthodontic appliance bonding; one-time assessment)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Patients' satisfaction
기간: At the end of leveling and alignment which is expected to occur within 4 to 6 months
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Satisfaction is assessed for both groups by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of satisfaction.
The left end of the line refers to no satisfaction (VAS=0) where the right end refers to maximum satisfaction (VAS=100).
The level of satisfaction is represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient.
This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the satisfaction.
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At the end of leveling and alignment which is expected to occur within 4 to 6 months
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Ease of the procedure
기간: At the end of leveling and alignment which is expected to occur within 4 to 6 months
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Procedure's easiness is assessed for both groups by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of ease.
The left end of the line refers to no ease (VAS=0) where the right end refers to maximum ease (VAS=100).
The grade of ease is represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient.
This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the ease of the procedure.
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At the end of leveling and alignment which is expected to occur within 4 to 6 months
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The possibility of repeating the procedure
기간: At the end of leveling and alignment which is expected to occur within 4 to 6 months
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Patients in the corticision group will be asked about the possibility of repeating the procedure if they had the chance to give their decision again.
The answer will be collected using a two-point scale (1.
Yes or 2. No).
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At the end of leveling and alignment which is expected to occur within 4 to 6 months
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Recommendation to a friend
기간: At the end of leveling and alignment which is expected to occur within 4 to 6 months
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Patients in the corticision group will be asked about if they would recommend this procedure to a friend.
The answer will be collected using a two-point scale (1.
Yes or 2. No).
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At the end of leveling and alignment which is expected to occur within 4 to 6 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Mohamad Radwan Sirri, DDS MSc, MSc student in Orthodontics, University of Damascus Dental School
- 연구 의자: Ahmad S Burhan, DDS MSc PhD, Professor of Orthodontics, University of Damascus, Damascus, Syria
- 연구 책임자: Mohammad Y Hajeer, DDS MSc PhD, Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Gibreal O, Hajeer MY, Brad B. Evaluation of the levels of pain and discomfort of piezocision-assisted flapless corticotomy when treating severely crowded lower anterior teeth: a single-center, randomized controlled clinical trial. BMC Oral Health. 2019 Apr 16;19(1):57. doi: 10.1186/s12903-019-0758-9.
- Alkebsi A, Al-Maaitah E, Al-Shorman H, Abu Alhaija E. Three-dimensional assessment of the effect of micro-osteoperforations on the rate of tooth movement during canine retraction in adults with Class II malocclusion: A randomized controlled clinical trial. Am J Orthod Dentofacial Orthop. 2018 Jun;153(6):771-785. doi: 10.1016/j.ajodo.2017.11.026.
- Charavet C, Lecloux G, Bruwier A, Rompen E, Maes N, Limme M, Lambert F. Localized Piezoelectric Alveolar Decortication for Orthodontic Treatment in Adults: A Randomized Controlled Trial. J Dent Res. 2016 Aug;95(9):1003-9. doi: 10.1177/0022034516645066. Epub 2016 Apr 29.
- Uribe F, Davoody L, Mehr R, Jayaratne YSN, Almas K, Sobue T, Allareddy V, Nanda R. Efficiency of piezotome-corticision assisted orthodontics in alleviating mandibular anterior crowding-a randomized clinical trial. Eur J Orthod. 2017 Nov 30;39(6):595-600. doi: 10.1093/ejo/cjw091.
- Yavuz MC, Sunar O, Buyuk SK, Kantarci A. Comparison of piezocision and discision methods in orthodontic treatment. Prog Orthod. 2018 Oct 29;19(1):44. doi: 10.1186/s40510-018-0244-y.
연구 기록 날짜
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)
2017년 3월 15일
기본 완료 (실제)
2018년 9월 15일
연구 완료 (실제)
2019년 2월 15일
연구 등록 날짜
최초 제출
2020년 4월 13일
QC 기준을 충족하는 최초 제출
2020년 4월 15일
처음 게시됨 (실제)
2020년 4월 16일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 4월 16일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 4월 15일
마지막으로 확인됨
2020년 4월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- UDDS-Ortho-03-2020
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .