- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07723326
Comparison of Electrocautery and Scalpel Blade Incisions of Impacted Mandibular Third Molars
Comparison of Electrocautery and Scalpel Blade Incisions on Postoperative Pain, Intraoperative Blood Loss, and Wound Healing Following Surgical Extraction of Impacted Mandibular Third Molars: A Randomized Controlled Trial
연구 개요
상태
상세 설명
Surgical extraction of impacted mandibular third molars is one of the most common procedures in oral and maxillofacial surgery. The type of incision used may influence postoperative outcomes, including pain, bleeding, and wound healing. Electrocautery offers simultaneous cutting and coagulation, potentially reducing intraoperative blood loss and improving surgical visibility, whereas scalpel incisions produce precise tissue cuts without thermal injury.
This prospective, two-arm, parallel-group, randomized controlled trial will compare electrocautery and scalpel blade incisions in patients undergoing surgical extraction of impacted mandibular third molars. Seventy-eight participants will be randomly assigned to either Arm A (scalpel blade incision) or Arm B (electrocautery incision). All other surgical and perioperative variables, including local anesthesia, flap design, irrigation, suture material, and postoperative medications, will be standardized.
The primary outcome is postoperative pain assessed using a Visual Analogue Scale at 24 hours, 48 hours, and 7 days. Secondary outcomes include intraoperative blood loss and wound healing assessed using the Landry Wound Healing Index at 1 and 4 weeks. The findings of this study will provide evidence regarding the most appropriate incision technique for impacted mandibular third-molar surgery.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Muhammad Usama, BDS/FCPS
- 전화번호: +923325595484
- 이메일: usamakhan123478@gmail.com
연구 연락처 백업
- 이름: Uzair Luqman, BDS/FCPS
- 전화번호: +923215080354
- 이메일: uzair.luqman@riphah.edu.pk
연구 장소
-
-
-
Islamabad, 파키스탄, 44000
- Islamic International Dental Hospital
-
연락하다:
- Muhammad Usama, BDS/FCPS
- 전화번호: +923325595484
- 이메일: usamakhan123478@gmail.com
-
수석 연구원:
- Uzair Luqman, BDS/FCPS
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Male and female patients.
- Age 15 to 65 years.
- Patients requiring surgical extraction of an impacted mandibular third molar. Patients classified as ASA I or ASA II.
- Patients willing to provide written informed consent, or assent with parent/guardian permission where applicable, and attend scheduled follow-up visits
Exclusion Criteria:
* Patients with uncontrolled systemic disease or immuno-compromised status.
- Patients with bleeding disorders or those taking anticoagulant/antiplatelet drugs that cannot be safely withheld according to physician advice.
- Patients with pacemaker or implanted electrical cardiac device.
- Pregnant or lactating patients.
- Patients with acute infection, pericoronitis, facial space infection, or pus discharge at the surgical site at the time of surgery.
- Patients requiring bilateral third-molar extraction in the same sitting.
- Patients unwilling to participate or unable to return for follow-up.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: scalpel blade incision group
Participants will undergo surgical extraction of impacted mandibular third molars using a sterile No. 15 scalpel blade for the mucoperiosteal flap incision
|
A sterile No. 15 stainless-steel scalpel blade will be used to make the mucoperiosteal flap incision during surgical extraction of the impacted mandibular third molar.
|
|
실험적: electrocautery incision group
Participants will undergo surgical extraction of impacted mandibular third molars using electrocautery in cutting mode for the mucoperiosteal flap incision
|
A fine electrocautery electrode in cutting mode at a standardized effective power setting will be used to make the mucoperiosteal flap incision during surgical extraction of the impacted mandibular third molar.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
postoperative pain
기간: 24 hours, 48 hours, and 7 days after surgery.
|
Postoperative pain at the surgical site will be assessed using a 0-10 Visual Analogue Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain
|
24 hours, 48 hours, and 7 days after surgery.
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
intraoperative blood loss
기간: During surgery (from first incision to final suture).
|
Total blood loss will be calculated as the increase in gauze weight plus the suction-canister volume after subtracting the recorded irrigation volume.
Results will be reported in milliliters (mL).
|
During surgery (from first incision to final suture).
|
|
wound healing
기간: 1 week and 4 weeks after surgery.
|
Wound healing will be assessed using the Landry Wound Healing Index, scored from 1 (very poor) to 5 (excellent).
|
1 week and 4 weeks after surgery.
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Uzair Luqman, BDS/FCPS, department of ORAL AND MAXILLOFACIAL SURGERY ISLAMIC INTERNATIONAL DENTAL HOSPITAL
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
기타 연구 ID 번호
- IIDC/IRC/2026/7/001
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. .
scalpel blade incision에 대한 임상 시험
-
Cairo University알려지지 않은
-
The University of Texas Health Science Center,...완전한
-
Mario Zamudio모병
-
Mansoura University아직 모집하지 않음