Local Application of Insulin Versus Hyaluronic Acid in Stage III Periodontitis
Evaluation of Local Application of Insulin Versus Hyaluronic Acid in Stage III Periodontitis Patients: A Randomized Controlled Clinical Trial
The present study will be performed on fourty-five patients suffering from periodontitis according to the criteria of American academy of periodontology to evaluate clinically effect of topical application of insulin versus hyaluronic acid as an adjunct to non surgical periodontal therapy in stage Ⅲ periodontitis patients.
This will be done by:
- Clinical assessment.
- Biochemical analysis. - Dose the topical application of insulin or hyaluronic acid as an adjunct to non-surgical periodontal therapy improves periodontal condition in stage Ⅲ periodontitis patients? PICO P (Population): patients with stage Ⅲ periodontitis. I (Intervention): non surgical periodontal therapy (SRP) with topical application using insulin or hyaluronic acid in periodontal pockets.
C (Comparison): topical application of insulin versus hyaluronic acid and SRP alone in periodontal pocket.
O (Outcome): primary outcome: change in periodontal pocket depth (PPD) or clinical attachment loss (CAL). Secondary outcome: change in gingival index (GI) or bleeding on probing index (BOP) and levels of IL-1β in GCF of treated pocket.
Study type: Randomized controlled trials (RCTs).
연구 개요
상태
상세 설명
The design of this clinical trial will be randomized double blind technique; the randomization of the patients will be performed through a computer program.
The randomization of patients will form the following 3 groups:
Group (Ⅰ): control group including (15) stage Ⅲ periodontitis patients who will receive scaling and root planning (SRP) alone.
Group (Ⅱ): including (15) stage Ⅲ periodontitis patients who will receive topical application of insulin adjunct to SRP.
Group (Ⅲ): including (15) stage Ⅲ periodontitis patients who will receive topical application of hyaluronic acid adjunct to SRP.
연구 유형
등록 (추정된)
단계
- 초기 1단계
연락처 및 위치
연구 장소
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-
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Cairo, 이집트
- 모병
- Alazhar University
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연락하다:
- Doaa Abdelrazik, BDS
- 전화번호: 00201012430093 00201012430093
- 이메일: duaaabdelrazik@gmail.com
-
Cairo, 이집트
- 모병
- Faculty of Dental Medicine for Girls, Al-Azhar University
-
연락하다:
- Doaa Abdelrazik, BDS
- 전화번호: 00201012430093
- 이메일: duaaabdelrazik@gmail.com
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- All selected patients are free from systemic illness as evaluated according to dental modification of the Cornell medical index.
- Should be diagnosed as having periodontitis.
- Not received any type of periodontal treatment in the past 6 months prior to examination.
- Should be cooperative, motivated, and willing to follow our treatment protocol and follow up visits.
- Not received antibiotics or anti-inflammatory therapy in the 6 months prior to examination.
Exclusion Criteria:
- Antibiotic therapy in the preceding 6 months or during study participation.
- History of insulin dependent diabetes and thyroid disease.
- Pregnancy, smoking, chronic diseases such as diabetes mellitus or rheumatoid arthritis, and allergy to ingredients in the drug.
- Poor oral hygiene compliance or inability to adhere to the clinical protocol.
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 |
|---|---|
|
활성 비교기: scaling and root planning and topical insulin for stage Ⅲ periodontitis patients
Participants receive scaling and root planing followed by topical application of insulin gel into periodontal pockets.
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subgingival scaling and root planning with topical application of insulin gel into periodontal pockets after scaling and root planing.tion of insulin
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실험적: scaling and root planning with topical application of hyaluronic acid gel
Participants receive scaling and root planing followed by topical application of hyaluronic acid gel into periodontal pockets.
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Topical application of hyaluronic acid gel into periodontal pockets after scaling and root planing.
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활성 비교기: Stage III periodontitis patients
patients have stage III periodontitis
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sub gingival scaling and root planning of periodontal pockets
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Periodontal pocket depth (PPD)
기간: 3-6 months
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(PD) measured in (mm) from free gingival margin to the base of the pocket at six sites per tooth (mesiobuccal and mesiolingual, distobuccal and distolingual, and mid-buccal and mid-lingual regions).
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3-6 months
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Clinical attachment loss (CAL)
기간: 3-6 months
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(CAL) measured in(mm)from the cemento-enamel junction (CEJ) to the base of the pocket at the same previous six sites per tooth.
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3-6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in gingival index (GI)
기간: 3-6 months follow up
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(GI) index measured at 4 sites per tooth (buccal, mesial, distal, and lingual).
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3-6 months follow up
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Change in bleeding on probing index (BOP)
기간: 3-6 months follow up
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(BOP) determined by the presence or absence of bleeding (with in15 sec.) after periodontal probing.
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3-6 months follow up
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Change in levels of IL-1β in gingival crevicular fluid (GCF) of treated pocket
기간: 3-6 months follow up
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Using the Bioassay Technology Laboratory IL-1β ELISA kit to determine levels of IL-1β in (GCF) using enzyme-linked immunosorbent assay (ELISA).
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3-6 months follow up
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Plaque index (PI)
기간: From 3 to 6 months
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PI describe by scores according to Loe H and Sillness J.
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From 3 to 6 months
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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
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
- OMPDR-105-2K
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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