- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07625839
A Comparative Clinical Assessment of Adjunctive Hyaluronic Acid With 3D Printed Versus Milled CAD CAM Provisional Dental Restorations on Active Periodontal Status and Surface Roughness and Biocompatibility
A Comparative Clinical Assessment of Adjunctive Hyaluronic Acid With 3D Printed Versus Milled CAD CAM Provisional Dental Restorations on Active Periodontal Status and Surface Roughness and Biocompatibility (A Randomized Controlled Clinical Trial)
연구 개요
상태
상세 설명
This randomized clinical trial evaluates their effects regarding periodontal assessment, including
- Clinical attachment loss (CAL)
- Plaque Index (PI)
- Gingival Index (GI)
- Bleeding on probing (BOP)
- using digital scanner then a profilometer to measure surface roughness
연구 유형
등록 (추정된)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
Systemic healthy patients
- Patients aged > 25 years
- Patients suffering from stage II periodontitis with grade B were included in this study, according to 2017 world workshop classification of periodontal disease (Papapanou et al. 2017).
- Patients with interdental clinical attachment loss (CAL) of 3-4 mm
- No history of previous periodontal therapy.
- No taken medications known to interfere healing or periodontal tissue health such as anticonvulsants, calcium channel blockers, or immunosuppressant drugs.
- No previous periodontal surgery at involved sites.
- Good oral hygiene and good compliance with the plaque control instructions following initial therapy.
- Neither taken antibiotics within the last three months nor nonsteroidal anti-inflammatory drugs within the last three months
- Absence of diseases or conditions that would interfere with wound healing such as diabetes mellitus or coagulation disorders
- Absence of oral mucosal inflammatory conditions such as aphthous ulcers or lichen planus.
Exclusion Criteria:
Smoking habits
- Pregnant and lactating mothers
- Patients who have been received periodontal surgery in the study area during the last 6 months
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: Intervention Study Group
Group (A and B): 3D Printed Dental Restoration with hyaluronic acid and Milled CAD CAM Dental Restoration with hyaluronic acid.
|
While control both procedures will be done but without using hyaluronic acid |
|
활성 비교기: Control Group
Group (C and D): 3D Printed Dental Restoration without hyaluronic acid and Milled CAD CAM Dental Restoration without hyaluronic acid
|
While control both procedures will be done but without using hyaluronic acid |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Clinical Attachment Loss (CAL)
기간: Day 0 - month 3
|
• will be measured clinically using UNC periodontal probe from cemento enamel junction to depth of periodontal pocket
|
Day 0 - month 3
|
|
bleeding on probing (BOP)
기간: Day 0 - month 3
|
will be measured clinically using UNC periodontal probe. Count the bleeding points and divided them by the total number of patients' teeth in the oral cavity and multiply by 100 to make the percent. localized less than 30% and generalized greater than or equal 30% |
Day 0 - month 3
|
|
Plaque index (PI)
기간: Day 0 - month 3
|
plaque index This clinical method assesses the thickness of plaque specifically at the cervical margin (gumline). The Scoring Scale (0 to 3): 0: No plaque in the gingival area.
|
Day 0 - month 3
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
biocompatibility
기간: Day 0 - month 3
|
• will be calculated through measuring Bop, gingival index, and plaque index as mentioned before.
|
Day 0 - month 3
|
|
Surface roughness
기간: Day 0 - month 3
|
will be measured using a surface roughness measuring instrument (or profilometer) is a precision device used to evaluate the texture of a material by measuring microscopic peaks and valleys.
They are essential for quality control in manufacturing to ensure components meet strict friction, wear, and coating adhesion standards.
|
Day 0 - month 3
|
공동 작업자 및 조사자
스폰서
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
- 15022026
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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