- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03028727
Diode Laser Therapy As An Adjunct To Scaling And Root Planing
Diode Laser Therapy As An Adjunct To Non-Surgical Management Of Chronic Periodontitis - A Pilot Study
연구 개요
상세 설명
Conventional mechanical debridement can achieve a temporary decrease in the subgingival levels of Pg along with other pathogens. However, mechanical therapy alone may fail to eliminate pathogenic bacterial niches in inaccessible areas like deep pockets, root concavities, furcation areas etc. In search of more efficient and less traumatic techniques to improve periodontal healing, researchers proposed the use of lasers in periodontal therapy.
The adjunctive use of lasers with conventional tools may facilitate treatment and have the potential to improve healing. The diode laser is highly absorbed in hemoglobin and other pigments and is excellent for use in soft tissue surgical procedures.Laser application in improving clinical outcome in periodontal therapy, needs to be further investigated with well designed clinical trials. The investigators attempted to evaluate the efficacy of diode laser as an adjunct to SRP in the management of CP by evaluating clinical parameters coupled with quantitative estimation of P.gingivalis using Real-time Polymerase chain reaction (RT-PCR) assay.
연구 유형
등록 (실제)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 40 systemically healthy subjects diagnosed with generalized moderate CP in the age group of 30 to 50 years.
- Minimum of 20 teeth having atleast two non-adjacent sites per quadrant with probing pocket depth of ≥ 5mm and clinical attachment loss of 3- 4 mm
Exclusion Criteria:
- Patients who had undergone periodontal therapy 6 months prior to the commencement of the study.
- Subjects on antibiotics or immunosuppressants.
- Chronic smokers, alcoholics, smokeless tobacco users.
- Subjects with acute illnesses/acute intraoral lesions.
- Pregnant women
- Subjects who had undergone extensive restorative dental treatment.
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 |
|---|---|
|
활성 비교기: Ultrasonic Scaling, Root planing
Ultrasonic Scaling and Root planing at day 0 and at 1 week.
|
Procedure of scaling and root planing at day 0 and at 1 week
|
|
실험적: 980 nm diode Laser irradiation
Irradiation of periodontal pockets with with 980 nm diode Laser after scaling and root planing at day 0 and after 1 week.
|
Procedure of scaling and root planing at day 0 and at 1 week
Procedure of scaling and root planing and application of 980 nm diode laser at day 0 and at 1 week
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in levels of P.gingivalis
기간: 14 weeks
|
Microbial profile was assessed using PCR at baseline, 4-6 weeks and 12-14 weeks post treatment in both the study groups.
|
14 weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in gingival index
기간: 14 weeks
|
Gingival index by Loe and Silness was assessed at baseline, 4-6 weeks and 12-14 weeks post treatment in both the groups
|
14 weeks
|
|
Change in plaque index
기간: 14 weeks
|
Plaque index by Silness and Loe was assessed at baseline, 4-6 weeks and 12-14 weeks
|
14 weeks
|
|
Change in probing pocket depth
기간: 14 weeks
|
Probing pocket depth was assessed at baseline, 4-6 weeks and 12-14 weeks
|
14 weeks
|
|
Change in clinical attachment level
기간: 14 weeks
|
Clinical attachment level was assessed at baseline, 4-6 weeks and 12-14 weeks
|
14 weeks
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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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