- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05536596
Pharmacological Treatment on the Recovery of Neurosensory Disturbance After Bilateral Sagittal Split Osteotomy
Pharmacological Treatment on the Recovery of Neurosensory Disturbance After Bilateral Sagittal Split Osteotomy: a Randomized, Double-blind Trial
연구 개요
상태
상세 설명
The study will be done according to the international standards of the Helsinki convention for medical research and approved by the scientific ethics committee of Universidad de los Andes Clinic.
All subjects will give their signed consent to participate of this clinical research.
This clinical randomized trial will be double-blinded as both the patient and the surgeon will not know the treatment used until the experiment is over. The randomization will be done using "random.org" software to assign participants into 4 groups. Groups A, B and C will receive the medication, whereas the Group P will receive a placebo.
연구 유형
등록 (예상)
단계
- 2 단계
- 3단계
연락처 및 위치
연구 연락처
- 이름: Pedro Sole, DMD, OMFS
- 전화번호: +56 9 9235 2728
- 이메일: psole@uic.es
연구 연락처 백업
- 이름: Maximiliano Bravo, DMD
- 전화번호: +56 9 7690 0878
- 이메일: mabravo9@uc.cl
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria: Patients with dentomaxillofacial anomalies who present a complete mandibular dental arch and who have not undergone previous mandibular surgery.
Exclusion Criteria:
patients who:
- do not have sufficient information in their clinical records
- cannot be contacted
- do not attend their check-ups (for at least 24 postoperative months in cases with DNS)
- have refused consent to the use of their information for purposes of research.
- already undergoing Orthognathic Surgery
- with systemic conditions prone to alter recovery patterns or serious systemic diseases (decompensated metabolic disorders; neoplasms; osteodysplasias; neuropathies).
- pregnancy
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: Citoneurone
Groups A will receive the pharmacology treatment with 1.5 mg uridine triphosphate, 2.5 mg cytidine monophosphate and 1 mg hydroxycobalamin (Citoneurone).
One capsule orally three times a day for 60 days as suggested by the manufacturer for patients with trauma - compressive peripheral neural disorders.
|
Prognathism/Retrognathism correction through surgical procedures
다른 이름들:
Groups A will receive the pharmacology treatment with 1.5 mg uridine triphosphate, 2.5 mg cytidine monophosphate and 1 mg hydroxycobalamin (Citoneuron).
One capsule orally three times a day for 60 days as suggested by the manufacturer for patients with trauma - compressive peripheral neural disorders.
다른 이름들:
|
실험적: Melatonin
Group B will receive the pharmacology treatment with 10 mg Melatonin.
One capsule orally at night for 60 days.
|
Prognathism/Retrognathism correction through surgical procedures
다른 이름들:
Group B will receive the pharmacology treatment with 10 mg Melatonin.
One capsule orally at night for 60 days.
|
실험적: Hydroxycobalamin
Group C will receive the pharmacology treatment with 1 mg hydroxycobalamin (vitamin B12).
One capsule daily for 60 days.
|
Prognathism/Retrognathism correction through surgical procedures
다른 이름들:
Group C will receive the pharmacology treatment with 1 mg hydroxycobalamin (vitamin B12).
One capsule daily for 60 days.
|
위약 비교기: Placebo
The controls will receive 1 capsule placebo containing 5 mg starch to be taken once daily.
|
Prognathism/Retrognathism correction through surgical procedures
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Neurosensory Activity
기간: pre-operative
|
Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others
|
pre-operative
|
Neurosensory Activity
기간: 1 day postoperative
|
Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others
|
1 day postoperative
|
Neurosensory Activity
기간: 3 day postoperative
|
Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others
|
3 day postoperative
|
Neurosensory Activity
기간: 2 weeks postoperative.
|
Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others
|
2 weeks postoperative.
|
Neurosensory Activity
기간: 1 month postoperative
|
Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others
|
1 month postoperative
|
Neurosensory Activity
기간: 2 month postoperative
|
Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others
|
2 month postoperative
|
Neurosensory Activity
기간: 6 month postoperative
|
Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others
|
6 month postoperative
|
Neurosensory Activity
기간: 12 month postoperative
|
Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others
|
12 month postoperative
|
Neurosensory Activity
기간: 18 month postoperative
|
Presence or absense of symptoms and signs such as hypoesthesia, pain, anesthesia, numbness, among others
|
18 month postoperative
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Subjective Test
기간: pre-operative, at day 1 and 3, at week 2, and at month 1, 2, 6, 12 and 18 after surgery.
|
Subjective testing using a questionnaire and visual analogue scale.
0 = normal sensation, 10= more severe sensory deficit.
|
pre-operative, at day 1 and 3, at week 2, and at month 1, 2, 6, 12 and 18 after surgery.
|
Objetive Test
기간: pre-operative, at day 1 and 3, at week 2, and at month 1, 2, 6, 12 and 18 after surgery.
|
The Semmes-Weinstein (SW) test of sensitivity to touch/pressure will be used.
|
pre-operative, at day 1 and 3, at week 2, and at month 1, 2, 6, 12 and 18 after surgery.
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Pedro Sole, DMD, OMFS, Universidad de Los Andes
간행물 및 유용한 링크
일반 간행물
- Ylikontiola L, Kinnunen J, Oikarinen K. Factors affecting neurosensory disturbance after mandibular bilateral sagittal split osteotomy. J Oral Maxillofac Surg. 2000 Nov;58(11):1234-9; discussion 1239-40. doi: 10.1053/joms.2000.16621.
- Colella G, Cannavale R, Vicidomini A, Lanza A. Neurosensory disturbance of the inferior alveolar nerve after bilateral sagittal split osteotomy: a systematic review. J Oral Maxillofac Surg. 2007 Sep;65(9):1707-15. doi: 10.1016/j.joms.2007.05.009.
- Alolayan AB, Leung YY. Resolution of neurosensory deficit after mandibular orthognathic surgery: A prospective longitudinal study. J Craniomaxillofac Surg. 2017 May;45(5):755-761. doi: 10.1016/j.jcms.2017.01.032. Epub 2017 Feb 12.
- Teerijoki-Oksa T, Jaaskelainen SK, Forssell K, Forssell H, Vahatalo K, Tammisalo T, Virtanen A. Risk factors of nerve injury during mandibular sagittal split osteotomy. Int J Oral Maxillofac Surg. 2002 Feb;31(1):33-9. doi: 10.1054/ijom.2001.0157.
- da Costa Senior O, Gemels B, Van der Cruyssen F, Agbaje JO, De Temmerman G, Shaheen E, Lambrichts I, Politis C. Long-term neurosensory disturbances after modified sagittal split osteotomy. Br J Oral Maxillofac Surg. 2020 Oct;58(8):986-991. doi: 10.1016/j.bjoms.2020.05.010. Epub 2020 Jul 4.
- Seddon HJ. A Classification of Nerve Injuries. Br Med J. 1942 Aug 29;2(4260):237-9. doi: 10.1136/bmj.2.4260.237. No abstract available.
- Schlund M, Grall P, Ferri J, Nicot R. Effect of modified bilateral sagittal split osteotomy on inferior alveolar nerve neurosensory disturbance. Br J Oral Maxillofac Surg. 2022 Oct;60(8):1086-1091. doi: 10.1016/j.bjoms.2022.04.001. Epub 2022 Apr 13.
- Yoshioka I, Tanaka T, Khanal A, Habu M, Kito S, Kodama M, Oda M, Wakasugi-Sato N, Matsumoto-Takeda S, Seta Y, Tominaga K, Sakoda S, Morimoto Y. Correlation of mandibular bone quality with neurosensory disturbance after sagittal split ramus osteotomy. Br J Oral Maxillofac Surg. 2011 Oct;49(7):552-6. doi: 10.1016/j.bjoms.2010.09.014. Epub 2010 Nov 10.
- van Merkesteyn JP, Zweers A, Corputty JE. Neurosensory disturbances one year after bilateral sagittal split mandibular ramus osteotomy performed with separators. J Craniomaxillofac Surg. 2007 Jun-Jul;35(4-5):222-6. doi: 10.1016/j.jcms.2007.04.006. Epub 2007 Jul 30.
- Panula K, Finne K, Oikarinen K. Neurosensory deficits after bilateral sagittal split ramus osteotomy of the mandible--influence of soft tissue handling medial to the ascending ramus. Int J Oral Maxillofac Surg. 2004 Sep;33(6):543-8. doi: 10.1016/j.ijom.2003.11.005.
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- PISV01
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .
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