- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07607028
Comparison of Ultrasonic vs 980-nm Diode Laser Irrigant Activation for Reducing Residual Bacterial DNA in Necrotic Teeth
Residual Bacterial DNA Detection After Ultrasonic vs 980-nm Diode Laser Irrigant Activation in Necrotic Teeth: A Pilot Randomized Clinical Study
연구 개요
상세 설명
Pulp necrosis is associated with microbial colonization and biofilm formation within the root canal system. Residual bacteria that persist after root canal treatment may contribute to persistent infection and unfavorable clinical outcomes. Although chemomechanical preparation and sodium hypochlorite irrigation are essential components of endodontic disinfection, anatomical complexities may limit complete bacterial elimination. Therefore, irrigant activation techniques have been introduced to improve irrigant penetration, biofilm disruption, and antimicrobial effectiveness.
Ultrasonic activation enhances irrigant movement through acoustic streaming and cavitation, whereas diode laser activation may produce additional photothermal antibacterial effects and deeper penetration into dentinal tubules. However, evidence comparing residual bacterial detection after these activation methods remains limited, particularly when evaluated using molecular identification techniques.
This exploratory randomized clinical trial compared ultrasonic irrigant activation and 980-nm diode laser irrigant activation in necrotic single-rooted teeth using 16S rRNA PCR sequencing. The study was conducted at the Dental and Oral Hospital of Hasanuddin University and the Hasanuddin University Medical Research Center, Indonesia. Sixteen necrotic single-rooted teeth were randomly allocated into two groups: ultrasonic activation (n = 8) and 980-nm diode laser activation (n = 8).
After rubber dam isolation and access preparation under aseptic conditions, initial microbial samples were collected before chemomechanical preparation. Root canal instrumentation was performed using ProGlider and ProTaper Gold rotary instruments up to F2. In both groups, canals were irrigated using 3% sodium hypochlorite. In the ultrasonic group, irrigant activation was performed using ultrasonic activation at 45 kHz for 20 seconds per cycle for three cycles. In the diode laser group, activation was performed using a 980-nm diode laser at 1.5 W for 20 seconds per cycle for three cycles. Post-treatment microbial samples were then collected.
Bacterial DNA was extracted and amplified using universal 16S rRNA primers, followed by sequencing and taxonomic identification. The primary outcome was the presence or absence of detectable oral bacterial DNA after treatment. Secondary outcomes included identification of bacterial taxa detected before and after treatment and comparison of bacterial profile reduction between activation methods.
The study was designed as an exploratory clinical-molecular investigation intended to generate preliminary evidence regarding the antibacterial effects of ultrasonic and diode laser irrigant activation in root canal disinfection.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
South Sulawesi
-
Makassar, South Sulawesi, 인도네시아, 90245
- Dental and Oral Hospital Hasanuddin University
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Adults aged 18 years or older
- Patients requiring endodontic treatment for mature single-rooted teeth diagnosed with pulp necrosis
- Physically and mentally able to undergo treatment
- No use of analgesics or antibiotics within one week before treatment
- Teeth without clinical or radiographic evidence of apical periodontitis
- Diagnosis confirmed by clinical examination, pulp vitality testing, and periapical radiography
Exclusion Criteria:
- Teeth with mobility
- Periodontal pockets greater than 4 mm
- Root fracture or fracture during treatment
- Internal or external root resorption
- Canal calcification or canal obliteration
- Patients with systemic conditions requiring antibiotic prophylaxis for routine dental treatment
- Recent antimicrobial exposure that could influence microbial findings
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: Ultrasonic Activation
Participants received root canal treatment with irrigant activation using ultrasonic activation in combination with 3% sodium hypochlorite irrigation.
Ultrasonic activation was performed at 45 kHz for 20 seconds per cycle for three cycles with irrigant renewal between cycles
|
Ultrasonic irrigant activation was performed during root canal treatment using an ultrasonic device at 45 kHz for 20 seconds per cycle for three cycles with 3% sodium hypochlorite irrigation.
|
|
실험적: 980-nm Diode Laser Activation
Participants received root canal treatment with irrigant activation using a 980-nm diode laser in combination with 3% sodium hypochlorite irrigation.
Laser activation was performed at 1.5 W for 20 seconds per cycle for three cycles with irrigant renewal between cycles.
|
Diode laser irrigant activation was performed during root canal treatment using a 980-nm diode laser at 1.5 W for 20 seconds per cycle for three cycles with 3% sodium hypochlorite irrigation.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Presence of Detectable Oral Bacterial DNA After Irrigant Activation
기간: Immediately after completion of irrigant activation during root canal treatment.
|
Detection of residual oral bacterial DNA in root canals after irrigant activation using ultrasonic activation or 980-nm diode laser activation, assessed by 16S rRNA PCR sequencing.
|
Immediately after completion of irrigant activation during root canal treatment.
|
공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Jambagi N, Kore P, Dhaded NS, Patil SA, Shankar M. Comparison of Antimicrobial Efficacy of Diode Laser, Ultrasonic Activated and Conventional Irrigation with 2.5% NaOCl during RCT: An Interventional Study. J Contemp Dent Pract. 2021 Jun 1;22(6):669-673.
- Siqueira JF Jr, Rocas IN. Present status and future directions: Microbiology of endodontic infections. Int Endod J. 2022 May;55 Suppl 3:512-530. doi: 10.1111/iej.13677. Epub 2022 Jan 13.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
키워드
기타 연구 ID 번호
- No. 265/KEPK FKG-RSGMP UH/EA/I
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. .