- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03620396
Comparison of Serum Trefoil Factor 3 in Patients With Gingivitis and Periodontitis After Scaling and Root Planing (CSTF3PGPSR)
Comparison of Serum Levels of Trefoil Factor 3 in Patients With Gingivitis and Periodontitis Following Non Surgical Periodontal Therapy
연구 개요
상세 설명
A goal of periodontal diagnostic procedure is to provide useful information to the clinician regarding the present periodontal disease type and severity. Advances in diagnostic research are moving towards methods where periodontal risk can be identified and quantified by objective measures such as Biomarkers.
Trefoil factors (TFFs) are one such secreted molecules derived from mucin producing epithelial cells of the gastro intestinal tracts and other tissues such as Salivary glands, Parotid ducts and oral mucosa. Among three Trefoil factors reported, Trefoil Factor 3 (TFF3) is the modifying factor for signalling pathway involved in cell survival, cell proliferation and cell migration of oral keratinocytes. Hence assessing the marker levels would achieve beneficial effects on diagnosing the disease severity.
연구 유형
등록 (실제)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
For Gingivitis:
- Gingival Index: 1.1 to 2.
- Modifies Plaque Index: 1.0 to 1.9
For Periodontitis:
- Gingival Index: 1.1 to 2.
- Modifies Plaque Index: 1.0 to 1.9
- Probing depth > 4mm
- Clinical attachment loss > 2mm
Exclusion Criteria:
For Gingivitis:
- Presence of gingival recession.
- Presence of clinical attachment loss.
- Presence of furcation.
- Presence of systemic infections like diabetes, infections.
- Smokers.
- Antibiotic therapy received preceding 3 months.
- Patients who underwent periodontal therapy within 3 months.
- Pregnant and Lactating women.
For Periodontitis:
- Presence of any systemic conditions like diabetes, infections.
- Smokers.
- Antibiotic therapy received preceding 3 months.
- Patients who underwent periodontal therapy within 3 months.
- Pregnant and Lactating women.
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: Experimental: Interventional
Group A patients consists of Gingivitis patients whose serum is collected at base line and treated with Scaling and root planing and after three months serum is collected for assessment of Trefoil factor 3.
|
After the serum collection is done from the patient for the assessment of trefoil factor 3, Non surgical periodontal therapy is carried out.
|
|
실험적: Experimental Interventional
Group B patients consists of Periodontitis patients whose serum is collected at base line and treated with Scaling and Root Planing and after three months serum is collected for assessment of Trefoil factor 3.
|
After the serum collection is done from the patient for the assessment of trefoil factor 3, Non surgical periodontal therapy is carried out.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Trefoil factor 3
기간: 3 months.
|
Blood samples were collected by venepuncture of anti-cubital vein.
2ml of blood was collected in each test tube.
10 minutes after collection, the test tube containing 2ml blood was subjected to centrifugation at 3000rpm for 10 min.
The supernatant straw colored fluid (serum) was separated into storage vials (Eppendorf tubes) for serum Trefoil Factor 3.
|
3 months.
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in the Gingival Index.
기간: 3 months
|
The severity of gingivitis is scored on all surfaces of selected teeth using Williams Periodontal probe. Index teeth- 16, 12, 24, 36, 32, 44. Score around each tooth is totalled and divided by 4-score of tooth. 0.1-1.0: Mild gingivitis. 1.1-2.0:Moderate gingivitis 2.1-3.0:Severe gingivitis |
3 months
|
|
Change in Modified Plaque Index
기간: 3 months
|
Examination of all the surfaces of the teeth are done using an explorer. The scores for individual teeth may be grouped and totalled and divided by the number of teeth. Excellent:0 Good:0.1-0.9 Fair:1.0-1.9 Poor:2-3 |
3 months
|
|
Change in Probing depth
기간: 3 months
|
The distance from the gingival margin to the depth of the pocket is measured using Williams periodontal probe.
|
3 months
|
|
Change in Clinical Attachment loss
기간: 3 months
|
The distance from the cementoenamel junction to the tip of the alveolar crest is measures using Williams periodontal probe.
|
3 months
|
공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Chaiyarit P, Chayasadom A, Wara-Aswapati N, Hormdee D, Sittisomwong S, Nakaresisoon S, Samson MH, Pitiphat W, Giraud AS. Trefoil factors in saliva and gingival tissues of patients with chronic periodontitis. J Periodontol. 2012 Sep;83(9):1129-38. doi: 10.1902/jop.2011.110431. Epub 2011 Dec 19.
- Storesund T, Schreurs O, Messelt EB, Kolltveit KM, Schenck K. Trefoil factor family 3 expression in the oral cavity. Eur J Oral Sci. 2009 Dec;117(6):636-43. doi: 10.1111/j.1600-0722.2009.00679.x.
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 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. .