- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07719270
Management of Postoperative Complications After Mandibular Third Molar Extraction Using Submucosal Triamcinolone Injection, Kinesiology Taping, and Standard Care
Comparative Analysis of Submucosal Triamcinolone Injection and Kinesiology Taping Along With Standard Care, and Standard Care Alone for the Management of Postoperative Complications in Patients After Surgical Mandibular 3rd Molar Extraction
The surgical removal of impacted lower wisdom teeth (mandibular third molars) frequently leads to uncomfortable postoperative symptoms, including pain, facial swelling (edema), and restricted jaw movement (trismus). This study aims to evaluate and compare the effectiveness of two different treatment strategies alongside standard care to reduce these complications.
A total of 60 patients undergoing surgical extraction will be randomly assigned to one of three groups: Group A will receive a local submucosal injection of 10mg Triamcinolone (a corticosteroid), Group B will have Kinesiology Tape applied to the face to enhance fluid drainage, and Group C will receive standard postoperative care alone. Patient recovery outcomes, including pain levels, facial swelling, and jaw mobility, will be monitored and measured at 24 hours, 3 days, and 7 days after the surgery. The study's primary objective is to determine if adding either a pharmacological injection or a mechanical tape significantly improves patient recovery compared to standard postoperative care alone.
연구 개요
상태
상세 설명
Surgical extraction of impacted mandibular third molars inevitably induces soft tissue trauma and bone disruption, triggering an acute inflammatory cascade primarily driven by arachidonic acid metabolites. This trial evaluates a head-to-head comparison between a localized pharmacological agent (corticosteroid) and a non-invasive mechanical intervention (kinesiology taping) to manage post-surgical sequelae.
Triamcinolone Acetonide is a potent synthetic corticosteroid designed to inhibit early-stage inflammatory pathways. Its submucosal administration aims to achieve high local drug concentration at the trauma site while minimizing systemic absorption risks. Conversely, Kinesiology Taping (KT) offers a non-pharmacological approach by microscopically lifting the skin over the masseteric region. This action is intended to reduce interstitial pressure, enhance local microcirculation, and accelerate lymphatic drainage.
This randomized controlled trial evaluates 60 eligible patients divided equally into three arms (n=20 per group):
- Group A: 10 mg Submucosal Triamcinolone combined with standard postoperative care.
- Group B: Face-applied Kinesiology Taping combined with standard postoperative care.
- Group C: Standard postoperative care alone (Control). Clinical outcomes including pain severity, facial swelling, and trismus will be quantified across three distinct postoperative follow-up intervals: 24 hours, 3 days, and 7 days. The gathered data will be analyzed to establish evidence-based guidance on optimizing patient comfort and recovery speed.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Kashaf Tariq, BDS, FCPS OMFS Resident
- 전화번호: +923326043105
- 이메일: kashaftariq6242@gmail.com
연구 장소
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Punjab Province
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Lahore, Punjab Province, 파키스탄, 54590
- Allama Iqbal Medical College & Jinnah Hospital
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연락하다:
- Kashaf Tariq, BDS, FCPS OMFS Resident
- 전화번호: +923326043105
- 이메일: kashaftariq6242@gmail.com
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Patients aged 18-40 years
- Surgical patients requiring extraction of Impacted mandibular third molars
Exclusion Criteria:
- Known allergy to corticosteroids/adhesive
- Systemic diseases
- Active infection
- Pregnancy and lactation
- Surgical duration > 45 minutes.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Group A (Triamcinolone + Standard Care)
Patients assigned to receive a single localized submucosal injection of 10mg Triamcinolone Acetonide immediately following surgical extraction of the lower third molar, alongside standard postoperative care.
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Single local submucosal injection of 10mg Triamcinolone Acetonide administered immediately after third molar surgical extraction.
Standard pharmacological regimen (routine oral analgesics/antibiotics) and post-operative home-care instructions.
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실험적: Group B (Kinesiology Taping + Standard Care)
Patients assigned to receive application of facial Kinesiology Taping (KT) immediately post-surgery to assist with lymphatic drainage, alongside standard postoperative care.
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Standard pharmacological regimen (routine oral analgesics/antibiotics) and post-operative home-care instructions.
Elastic kinesiology tape applied over the masseteric region immediately after surgery to assist in tissue decompression and lymphatic flow.
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다른: Group C (Standard Care Alone)
Patients assigned to receive standard postoperative pharmacological care alone (such as prescribed oral analgesics and routine post-extraction instructions) with no additional localized intervention.
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Standard pharmacological regimen (routine oral analgesics/antibiotics) and post-operative home-care instructions.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Postoperative Pain Severity
기간: Preoperatively (baseline), and at 24 hours, 3 days, and 7 days postoperatively
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Postoperative pain severity will be assessed using a 10-point Visual Analog Scale (VAS), where 0 indicates "no pain" and 10 indicates "the worst pain imaginable
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Preoperatively (baseline), and at 24 hours, 3 days, and 7 days postoperatively
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Postoperative Facial Swelling (Edema)
기간: Preoperatively (baseline), and at 24 hours, 3 days, and 7 days postoperatively
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Postoperative facial swelling will be assessed using quantitative facial measurements in millimeters (using standard landmark reference points like tragus to corner of the mouth, tragus to soft tissue pogonion, and lateral canthus to gonion)
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Preoperatively (baseline), and at 24 hours, 3 days, and 7 days postoperatively
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Postoperative Trismus
기간: Preoperatively (baseline), and at 24 hours, 3 days, and 7 days postoperatively.
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Postoperative trismus (limited mouth opening) will be quantified in millimeters by measuring the maximum interincisal distance at maximum active mouth opening using a digital vernier caliper
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Preoperatively (baseline), and at 24 hours, 3 days, and 7 days postoperatively.
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공동 작업자 및 조사자
수사관
- 연구 의자: Gulraiz Zulfiqar, BDS, FCPS OMFS, CHPE, Allama Iqbal Medical College, Lahore
간행물 및 유용한 링크
일반 간행물
- Wilkes MC, Scanlon V, Shibuya A, Cepika AM, Eskin A, Chen Z, Narla A, Glader B, Roncarolo MG, Nelson SF, Sakamoto KM. Downregulation of SATB1 by miRNAs reduces megakaryocyte/erythroid progenitor expansion in preclinical models of Diamond-Blackfan anemia. Exp Hematol. 2022 Jul;111:66-78. doi: 10.1016/j.exphem.2022.04.005. Epub 2022 Apr 20.
- Cavalcante DA, Gadelha A, Noto C. How challenging is to manage agitated patients? Braz J Psychiatry. 2019 Jul-Aug;41(4):277-278. doi: 10.1590/1516-4446-2019-4105. No abstract available.
- Zerener T, Aydintug YS, Sencimen M, Bayar GR, Yazici M, Altug HA, Misir AF, Acikel C. Clinical comparison of submucosal injection of dexamethasone and triamcinolone acetonide on postoperative discomfort after third molar surgery. Quintessence Int. 2015 Apr;46(4):317-26. doi: 10.3290/j.qi.a33281.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
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
- ERB/14/204/AIMC/JHL
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
미국에서 제조되어 미국에서 수출되는 제품
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