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SCREENING OF EPIGENETIC BIOMARKERS (miRNAs) IN THE GINGIVAL SULCUS

2018년 4월 26일 업데이트: ANA FUENMAYOR GARCÉS, University of Valencia

Screening of Epigenetic Biomarkers (miRNA) in the Gingival Sulcus

Epigenetics has produced a high impact in biomedical research and is providing new biomarkers for the diagnosis and prognosis of diseases. In addition, epigenetics is also contributing to analyze the molecular causes underlying diseases, even so periodontal diseases as it has been recently reviewed. In this regard, changes in the methylation of genes codifying for pro-inflammatory and anti-inflammatory cytokines has been previously reported. miRNAs are very promising biomolecules to be used as biomarkers because miRNAs act as signaling molecules and participate in many biological processes, such as cellular development, differentiation, and apoptosis. The high stability of circulating miRNAs in the RNase-rich environment of the bloodstream and also in different biospecimens used in clinical routine, make these biomolecules an optimal source of candidate biomarkers. In fact, miRNAs have demonstrated their value as dynamic biomarkers in a wide variety of human diseases. Therefore, miRNAs can be used for the monitoring of periodontal disease.

The objective of this research is to analyze the levels of bone remodeling RANKL / OPG biomolecular markers, and the epigenetic regulation of these proteins to identify promising biomarkers of periodontal disease.

Material and Methods. Levels of RANKL and OPG will be measured in the gingival crevicular fluid (GCF) to assess the state of bone. These samples will be sent to the lab for quantification by ELISA method.

Furthermore, new epigenetic biomarkers based on the identification of high stable microRNAs will be identified by qRT-PCR in GCF as feasible tools for diagnosis and monitoring of wide range of disease, including periodontal disease.

연구 개요

연구 유형

관찰

등록 (예상)

40

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • Valencia, 스페인
        • 모병
        • Ana Fuenmayor Garcés
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

30년 (성인)

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

Patients attending to the university who meet the inclusion criteria.

설명

Inclusion Criteria:

Group of periodontal patients:

  1. Clinical criteria: at least 3 locations in unirradicular teeth with PD 6 mm. 3 samples will be taken from each of these 3 locations (9 total samples). Third molars are not included in the study.
  2. Patients not treated periodontally.
  3. 30-60 years.

Periodontally healthy group:

1. Absence of clinical and radiographical periodontal pathology.

Exclusion Criteria:

  • Group of periodontal patients:

    1. Aggressive Periodontal Disease (Armitage, 1999).
    2. Patients with controlled periodontal disease with plaque and gingival indexes ≤20%.
    3. Patients with systemic diseases or taking medications that alter bone metabolism (Osteoporosis, arthritis, hormonal treatment, bisphosphonates, anti-inflammatory, immunosuppressants, etc ...).
    4. Patients with antibiotic, anti-inflammatory or contraceptive treatment in the previous 3 months or taking antiaggregants in the last 7 days before taking the sample.
    5. Smokers (> 10 cig. /day).
    6. Pregnant or breast-feeding.

Periodontally healthy group:

  1. Patients with systemic diseases or taking medications that alter bone metabolism (Osteoporosis, arthritis, hormonal treatment, bisphosphonates, anti-inflammatory, immunosuppressant...).
  2. Patients with antibiotic, anti-inflammatory or contraceptive treatment in the previous 3 months or taking antiaggregants in the last 7 days before taking the sample.
  3. Smokers (> 10 cig/day).
  4. Pregnant or breast-feeding.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
Periodontal patients.
Taking gingival Crevicular fluid.

Once the anamnesis has been done, all the records corresponding to the Gingival Index and Plaque Index, in both groups are taken.

Subsequently, samples of gingival crevicular fluid are taken for the screening of epigenetic biomarkers.

Periodontally healthy patients.
Taking gingival Crevicular fluid.

Once the anamnesis has been done, all the records corresponding to the Gingival Index and Plaque Index, in both groups are taken.

Subsequently, samples of gingival crevicular fluid are taken for the screening of epigenetic biomarkers.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
microRNA in gingival crevicular fluid (physiological parameter).
기간: 2 years.
Insert the Perio Paper® tip in gingival sulcus until resistance is felt and leave it for 30 seconds.
2 years.

2차 결과 측정

결과 측정
측정값 설명
기간
Probing depth.
기간: 2 years.
Probing depth will be measured in six sites (disto-buccal, mid-buccal, mesio-buccal, disto-palatal, mid-palatal and mesio- palatal) of every teeth with a Williams Probe PQ-OW 208 396. This probe is used by gently hanging pressure into a pocket measuring 20 grams in weight.
2 years.
Bleeding on probing.
기간: 2 years.
Full mouth bleeding score (FMBS) will be calculated based on scores of 0 (no bleeding) or 1 (bleeding) after probing for PD. The usual thing to do is to measure at 4 points for each tooth but we have modified the index and we valorate them at 6 points. (disto-buccal, mid-buccal, mesio-buccal, disto-palatal, mid-palatal and mesio- palatal).
2 years.
Clinical recession.
기간: 2 years.
Clinical recession will be measured in the same six sites as before between the Amelocemental junction and the gingival margin.
2 years.
Plaque score of Silness y löe: (1964)
기간: 2 years.

The Plaque will be scored as follows:

Score 0 = No plaque

Score 1 = A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface.

Score 2 = Moderate accumulation of soft deposits within the gingival pocket, or on the tooth and gingival margin, which can be seen with the naked eye.

Score 3 = Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.

The usual thing to do is to evaluate at 4 points for each tooth but we have modified the index and we will evaluate at 6 points. (disto-buccal, mid-buccal, mesio-buccal, disto-palatal, mid-palatal and mesio- palatal)

2 years.
Dental movility of Mïller 1950
기간: 2 years.

Class I

Up to 1 mm of movement in a horizontal direction.

Class II Greater than 1 mm of movement in a horizontal direction. Class III

Excessive horizontal movement and vertical movement.

2 years.
Furcation affection.
기간: 2 years.

Class I:

The level of bone loss allows for the insertion of the periodontal Nabers probe into the concavity of the root trunk. Furcation defect is less than 3 mm is depth.

Class II The level of bone loss allows for the insertion of a periodontal probe into the furcation area between the roots. Furcation defect is at least 3 mm in depth (and thus, in general, surpassing half of the buccolingual thickness of the tooth) but not through-and-through (i.e. there is still some interradicular bone attached to the angle of the furcation.

15

Class III The level of bone loss allows for "through and through" access of the furcation area. Buccal to lingual on lower molars. Buccal to mesio-palatal and disto-palatal on upper molars. Furcation defect encompassing the entire width of the tooth so that no bone is attached to the angle of the furcation.

2 years.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2017년 9월 15일

기본 완료 (예상)

2019년 7월 1일

연구 완료 (예상)

2019년 7월 1일

연구 등록 날짜

최초 제출

2018년 4월 1일

QC 기준을 충족하는 최초 제출

2018년 4월 26일

처음 게시됨 (실제)

2018년 4월 27일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 4월 27일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 4월 26일

마지막으로 확인됨

2018년 4월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • H1510580113419

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

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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3
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