Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances. (PDHOI)
Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances: a Randomized Controlled Trial
This study will evaluate whether personalized digital oral-health education delivered through WhatsApp messages can improve oral hygiene in patients aged 16-25 years who wear fixed orthodontic appliances (braces). A total of 66 participants will be assigned to two groups. The intervention group will receive weekly digital oral-health messages for 12 weeks, while the control group will receive conventional verbal oral-hygiene instructions. Both groups will receive the same antibacterial mouthwash. Oral hygiene will be assessed at the beginning of the study and after 12 weeks by measuring plaque and gingival health using the Plaque Index and Gingival Index. The findings will help determine whether digital education can support conventional oral-hygiene instructions for patients undergoing orthodontic treatment.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
This randomized controlled trial will evaluate the effectiveness of a personalized digital oral-health intervention in patients aged 16-25 years undergoing treatment with fixed orthodontic appliances.
A total of 66 eligible participants will be planned for enrollment and allocation into two groups in a 1:1 ratio, with 33 participants in each group.
The intervention group will receive weekly oral-health educational and motivational messages through WhatsApp over 12 weeks. The messages will address oral-hygiene practices during orthodontic treatment, including toothbrushing around fixed appliances, interdental cleaning, plaque control, gingival health, dietary habits, prevention of white spot lesions, and maintenance of oral hygiene.
The control group will receive conventional verbal oral-hygiene instructions. Both groups will receive the same alcohol-free antibacterial mouthwash to maintain consistency in this aspect of oral-hygiene care.
Clinical assessments will be conducted at baseline and after 12 weeks. Oral hygiene outcomes will be assessed using the Plaque Index and Gingival Index. The changes in these indices between the two assessment time points will be compared between the intervention and control groups.
The study is planned to recruit participants from dental centers in Erbil, Kurdistan Region, Iraq. Participation will be voluntary, and informed consent will be obtained before enrollment. For participants younger than 18 years, parental or guardian consent and participant assent will be obtained as applicable.
The findings are expected to provide evidence on whether digital oral-health education can support conventional oral-hygiene instructions for patients receiving fixed orthodontic treatment.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: lara Zozan zozan, BDS
- 전화번호: +964 4240732 +9647504240732
- 이메일: larazozan1990@gmail.com
연구 연락처 백업
- 이름: Muhammed Khalis Bilal, BDS
- 전화번호: +9647504459041
- 이메일: larazozan1990@gmail.com
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
IInclusion Criteria:
Patients aged 16-25 years.
Patients wearing fixed orthodontic appliances on both the maxillary and mandibular arches.
Patients who agree to participate in the study.
Exclusion Criteria:
Patients wearing fixed orthodontic appliances on only one arch (maxillary or mandibular).
Patients who do not meet the inclusion criteria.
Patients who decline to participate.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: Personalized Digital Oral Health Intervention
Participants will receive conventional verbal oral-hygiene instructions and the same study-provided antibacterial mouthwash as the control group. In addition, participants will receive weekly personalized digital oral-health messages through WhatsApp for 12 weeks. The messages will provide oral-hygiene education, motivation, and practical instructions for maintaining oral hygiene during fixed orthodontic treatment. |
A 12-week digital oral-health education intervention delivered through WhatsApp to patients undergoing fixed orthodontic treatment. Participants receive one oral-health message per week covering oral hygiene awareness, motivation, and practical instructions for maintaining oral hygiene around orthodontic appliances. Topics include toothbrushing techniques, interdental cleaning, gingival health, plaque control, dietary advice, prevention of white spot lesions, and orthodontic appliance care. The intervention is provided in addition to conventional verbal oral-hygiene instructions and the study-provided antibacterial mouthwash. |
|
활성 비교기: Standard Oral-Hygiene Instruction Group
Participants will receive conventional verbal oral-hygiene instructions and the same study-provided antibacterial mouthwash as the experimental group. They will not receive additional oral-health messages through WhatsApp during the 12-week study period. |
Conventional verbal oral-hygiene instructions provided to participants in the control group. Participants do not receive additional oral-health messages through WhatsApp during the 12-week study period. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Plaque Index (PI) from Baseline to 12 Weeks
기간: Baseline and 12 weeks after the start of the intervention.
|
Plaque will be assessed using the Silness and Löe Plaque Index. Scores range from 0 to 3, with higher scores indicating greater plaque accumulation and poorer oral hygiene. The change in score will be assessed between baseline and 12 weeks. |
Baseline and 12 weeks after the start of the intervention.
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Gingival Index (GI) from Baseline to 12 Weeks
기간: Baseline and 12 weeks after the start of the intervention.
|
Gingival inflammation will be assessed using the Löe and Silness Gingival Index. Scores range from 0 to 3, with higher scores indicating greater gingival inflammation and poorer gingival health. The change in score will be assessed between baseline and 12 weeks. |
Baseline and 12 weeks after the start of the intervention.
|
공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: lara Zozan MIran, BDS, Kurdistan Higher Council of Medical Specialtie
간행물 및 유용한 링크
유용한 링크
- <p>Balbaa et al. (2025) - Effectiveness of mobile oral health intervention on orthodontic patients' oral hygiene and oral health literacy: a randomized controlled clinical trial.</p>
- <p>Balbaa et al. (2025) - Mobile oral-health intervention in orthodontic patients: a randomized controlled clinical trial</p>
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- 1246
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
The decision regarding sharing individual participant data (IPD) has not yet been made. Any future decision will consider participant confidentiality, data privacy, ethical requirements, and applicable institutional policies.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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