- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03190512
Periodontal Treatment and Psychology
The Effect of Periodontal Treatment on Depression, Body Image, Self-Esteem and Anxiety in Depressed Patients: A Randomized Controlled Clinical Trial
연구 개요
상세 설명
Background: Depression is a multi-factorial disease characterized by a variety of symptoms. Psychiatric disorders seem to be more prone to periodontitis compared to patients without psychiatric disorders. However periodontal disease and depression can be considered bidirectional risk factors. Periodontal disease can also be an effect on depression. The aim of this randomized controlled clinical study is to determine the effect of non-surgical mechanical periodontal treatment on psychological state.
Material and methods: The study population consisted of 184 depressed patients with non-treated periodontal diseases. Two randomized group is formed from these patients. Immediately periodontal treatment (test group, n = 92) and delayed periodontal treatment (control group, n = 92). Clinical periodontal and psychological measures were performed at baseline and 6th weeks on control and test group.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Tokat, 칠면조, 60250
- Gaziosmanpasa University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- the presence of periodontal diseases,
- the presence of diagnosed minor depression
- being under maintenance therapy regarding the depression
Exclusion Criteria:
- any hormonal condition such as pregnancy or lactation
- received any periodontal treatment within six months
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Test Group
Psychological measurements were taken from periodontal disease patients before treatment and after 6 weeks. Intervention: Non-surgical periodontal treatment (SRP and oral hygiene instructions) was performed and the Psychological questionnaires were filled. |
Four questionnaire tests for depression, body image, self-esteem, and anxiety was performed baseline and after 6 weeks.
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위약 비교기: Control Group
Psychological measurements were taken from periodontal disease patients at the baseline and after 6 weeks without the periodontal treatment. Intervention: The Psychological questionnaires were filled. |
Four questionnaire tests for depression, body image, self-esteem, and anxiety was performed baseline and after 6 weeks.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Depression level
기간: Baseline and after 6 weeks
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The changes in depression level within 6 weeks.
Depression level was determined using the Beck Depression Inventory.
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Baseline and after 6 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Body image level
기간: Baseline and after 6 weeks
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The changes in body image level within 6 weeks.
Body image level was determined using the Body Cathexis Scale.
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Baseline and after 6 weeks
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Anxiety level
기간: Baseline and after 6 weeks
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The changes in anxiety level within 6 weeks.
Anxiety level was determined using the Beck Anxiety Inventory.
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Baseline and after 6 weeks
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Self-esteem level
기간: Baseline and after 6 weeks
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The changes in self-esteem level within 6 weeks.
Self-esteem level was determined using the Rosenberg Self-Esteem Scale.
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Baseline and after 6 weeks
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Probing pocket depth
기간: Baseline and after 6 weeks
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The changes in probing pocket depth after periodontal treatment.Probing pocket depth was measured for determining severity of disease and clinic outcome.
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Baseline and after 6 weeks
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Clinical attachment level
기간: Baseline and after 6 weeks
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The changes in clinical attachment level after periodontal treatment.
Clinical attachment level was measured for determining severity of disease and clinic outcome.
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Baseline and after 6 weeks
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Gingival index
기간: Baseline and after 6 weeks
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The changes in gingival index level after periodontal treatment.
Clinical attachment level was measured for determining severity of disease and clinic outcome.
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Baseline and after 6 weeks
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Plaque index
기간: Baseline and after 6 weeks
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The changes in plaque index after periodontal treatment.
Plaque index was recorded for determining and classifying oral hygiene status.
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Baseline and after 6 weeks
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Bleeding on probing
기간: Baseline and after 6 weeks
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The changes in bleeding on probing after periodontal treatment.
Bleeding on probing was recorded for classifying and evaluating (apically) gingival inflammation.
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Baseline and after 6 weeks
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Ozge Gokturk, Gaziosmanpasa Universty
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. .
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