- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07826715
Personalized 3D Visualization for Oral Hygiene and Motivation in Adults With Gingivitis
This study evaluated whether personalized three-dimensional images of possible future changes in the gums could improve oral hygiene and motivation in adults with gingivitis. Gingivitis is inflammation of the gums associated with dental plaque.
Eighty-four adults aged 18-60 years were randomly assigned to three groups of 28 participants. The groups received conventional oral hygiene education, general three-dimensional educational animations, or personalized three-dimensional visualization using models created from their own intraoral scans. All participants received the same nonsurgical periodontal treatment and instruction in toothbrushing and cleaning between the teeth.
The personalized images illustrated possible gum recession and tissue changes if periodontal care and daily plaque control were neglected. They were educational scenarios, not individual predictions of future disease. Personalized visualization was accompanied by a clinician-guided motivational discussion.
Dental plaque, gum inflammation, gum bleeding, and motivation toward dental treatment were assessed before treatment and six weeks later. The study compared these outcomes among the three educational approaches.
연구 개요
상태
정황
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Central
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Bolu, Central, 터키 (Türkiye), 14100
- Faculty of Dentistry, Bolu Abant İzzet Baysal University, Department of Periodontics
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Adults aged 18-60 years. Systemically healthy. Diagnosis of gingivitis according to the 2017 World Workshop classification. At least 20 natural teeth, excluding third molars. At least 12 years of formal education. Turkish as the native language. Probing depths ≤3 mm. Bleeding on probing at more than 10% of sites. Visible plaque at more than 50% of sites. Provision of written informed consent.
Exclusion Criteria:
- Dentists or dental students. Previous periodontal treatment or structured oral hygiene education. Use of antibiotics or nonsteroidal anti-inflammatory drugs within the preceding 3 months.
Generalized gingival recession or dentin hypersensitivity. Full-arch fixed or removable prostheses. Acute odontogenic infections. Overhanging or defective restorations, or root caries that could affect oral hygiene practices.
Active orthodontic treatment. Communicable diseases such as hepatitis or HIV infection. Cognitive, systemic, or physical conditions that could interfere with understanding the educational content or performing oral hygiene practices.
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 |
|---|---|
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활성 비교기: Conventional Method (CM)
Participants received nonsurgical periodontal treatment and conventional face-to-face oral hygiene education supported by practical demonstrations using a dental model and a written information leaflet.
Education covered periodontal disease, dental plaque, and daily oral hygiene practices, including the modified Bass toothbrushing technique and appropriate interdental cleaning.
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Face-to-face education delivered by a clinician using a dental model and a written information leaflet.
The content covered the causes of periodontal diseases, the role of dental plaque, and daily oral hygiene practices.
Participants received instruction in the modified Bass toothbrushing technique and appropriate interdental cleaning.
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활성 비교기: Three-Dimensional Animation (3DA)
Participants received nonsurgical periodontal treatment and clinician-guided oral hygiene education using DentalMaster three-dimensional educational software.
The educational content covered the causes and clinical signs of periodontal diseases, periodontal treatment, and daily oral care.
General three-dimensional animations illustrated potential gingival recession, periodontal tissue loss, and tooth loss associated with inadequate plaque control.
Participants were instructed in the modified Bass toothbrushing technique and appropriate interdental cleaning.
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Clinician-guided oral hygiene education using DentalMaster three-dimensional educational software.
The content covered the causes and clinical signs of periodontal diseases, periodontal treatment, and daily oral care.
General three-dimensional animations illustrated potential gingival recession, periodontal tissue loss, and tooth loss associated with inadequate plaque control.
Participants received instruction in the modified Bass toothbrushing technique and appropriate interdental cleaning.
|
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활성 비교기: Periodontal Disease Prediction (PDP)
Participants received nonsurgical periodontal treatment and clinician-guided education on periodontal disease and daily oral care.
Personalized three-dimensional dentogingival models generated from their intraoral scans using the Periodontal Disease Prediction (PDP) system illustrated potential gingival recession and visible tissue changes if periodontal care and plaque control were neglected.
Images were presented as conditional educational scenarios, not individualized prognostic predictions.
Visualization was accompanied by a motivational discussion addressing personal goals and barriers to oral hygiene.
Participants were instructed in the modified Bass toothbrushing technique and appropriate interdental cleaning.
|
Participants viewed general educational animations about periodontal disease, treatment, and daily oral care, followed by personalized three-dimensional dentogingival models generated from their own intraoral scans using the Periodontal Disease Prediction (PDP) system.
The models illustrated potential gingival recession and visible periodontal tissue changes if periodontal care and daily plaque control were neglected.
These images were presented as conditional educational scenarios, not individualized prognostic predictions.
A clinician-guided motivational discussion addressed personal goals and barriers to oral hygiene.
Participants also received instruction in the modified Bass toothbrushing technique and appropriate interdental cleaning.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Full-Mouth Rustogi Modified Navy Plaque Index From Baseline to Week 6
기간: Baseline and 6 weeks
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Dental plaque was assessed using the Rustogi Modified Navy Plaque Index (RMNPI) after application of a plaque-disclosing agent.
The facial and lingual/palatal surfaces of each eligible tooth were divided into nine areas, scored as 0 for absence of plaque or 1 for presence of plaque.
The full-mouth score was calculated as the proportion of assessed areas with plaque, ranging from 0 to 1, with higher scores indicating more plaque.
Third molars and teeth with crowns or cervical restorations were excluded.
Change was calculated as the week 6 score minus the baseline score; negative values indicate improvement.
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Baseline and 6 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Full-Mouth Gingival Index From Baseline to Week 6
기간: Baseline and 6 weeks
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Gingival inflammation was assessed using the Löe and Silness Gingival Index at four sites around each tooth.
Scores range from 0 to 3, with higher scores indicating more severe gingival inflammation.
A full-mouth mean score was calculated for each participant.
Change was calculated as the week 6 score minus the baseline score; negative values indicate improvement.
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Baseline and 6 weeks
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Change in Full-Mouth Papillary Bleeding Index From Baseline to Week 6
기간: Baseline and 6 weeks
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Interdental gingival bleeding was assessed using the Papillary Bleeding Index (PBI).
Interdental papillae were scored from 0 to 4 according to the severity of bleeding elicited after probing, with higher scores indicating more severe bleeding.
A full-mouth mean score was calculated for each participant.
Change was calculated as the week 6 score minus the baseline score; negative values indicate improvement.
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Baseline and 6 weeks
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Intrinsic Motivation Assessed by the Dental Treatment Motivation Scale
기간: Baseline and 6 weeks
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Intrinsic motivation was assessed using the seven-item intrinsic motivation subscale of the Dental Treatment Motivation Scale (DTMS).
Each item was rated on a five-point Likert scale from 1 (strongly disagree) to 5 (strongly agree).
The mean item score was calculated, ranging from 1 to 5, with higher scores indicating greater intrinsic motivation.
Scores were assessed at baseline and week 6 and compared among the three study groups.
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Baseline and 6 weeks
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Extrinsic Motivation Assessed by the Dental Treatment Motivation Scale
기간: Baseline and 6 weeks
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Extrinsic motivation was assessed using the eight-item extrinsic motivation subscale of the Dental Treatment Motivation Scale (DTMS).
Each item was rated on a five-point Likert scale from 1 (strongly disagree) to 5 (strongly agree).
The mean item score was calculated, ranging from 1 to 5, with higher scores indicating greater extrinsic motivation.
Scores were assessed at baseline and week 6 and compared among the three study groups.
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Baseline and 6 weeks
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공동 작업자 및 조사자
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 연구와 관련된 용어
기타 연구 ID 번호
- BAİBU-Perio-ZA-05
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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