Taste Acceptance and Effectiveness of Hyaluronic Acid and Chlorhexidine Mouthwashes in Children With Gingivitis
Taste Acceptance and Clinical Effectiveness of Hyaluronic Acid Versus Chlorhexidine Mouthwashes in Children With Plaque-Induced Gingivitis: A Randomized Controlled Trial
연구 개요
상태
정황
상세 설명
This study is a randomized, single-blind, controlled clinical trial designed to compare the taste acceptance and clinical effectiveness of a hyaluronic acid mouthwash and a chlorhexidine mouthwash in children aged 8 to 10 years with plaque-induced gingivitis.
Eligible participants will be recruited from the outpatient clinic and screened according to the study eligibility criteria. After obtaining informed consent from parents or legal guardians and assent from the children, baseline clinical assessments will be performed. Gingival inflammation will be evaluated using the Loe and Silness Gingival Index, and dental plaque accumulation will be assessed using the Silness and Loe Plaque Index.
Participants will be randomly assigned in a 1:1 ratio to one of two intervention groups. The intervention group will receive a hyaluronic acid mouthwash, while the control group will receive a chlorhexidine mouthwash. Allocation concealment will be maintained using sealed opaque envelopes prepared by an independent investigator. Clinical outcome assessment will be performed by a blinded examiner who will remain unaware of group allocation throughout the study period.
All participants will receive standardized oral hygiene instructions and identical instructions regarding mouthwash use. Participants will be instructed to use the assigned mouthwash twice daily for 14 days in addition to their routine toothbrushing practices.
Taste acceptance will be evaluated as the primary outcome using a validated facial hedonic scale following mouthwash use. Secondary outcomes will include changes in gingival inflammation and plaque accumulation, as measured by the Loe and Silness Gingival Index and the Silness and Loe Plaque Index, respectively.
Follow-up clinical examinations will be conducted after 14 days of intervention. Compliance with mouthwash use and any adverse events will be documented throughout the study period. The study aims to determine whether hyaluronic acid mouthwash provides comparable clinical effectiveness to chlorhexidine while demonstrating greater taste acceptance among children with plaque-induced gingivitis.
연구 유형
등록 (추정된)
단계
- 1단계
연락처 및 위치
연구 연락처
- 이름: Yasmeen AS Abdelqader, Bachelors
- 전화번호: +201018727929
- 이메일: Yasmeen.saleh@dentistry.cu.edu.eg
연구 장소
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Egypt
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Cairo, Egypt, 이집트, 11411
- Faculty of Dentistry, Cairo University
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Children aged from 8-12 years of both sexes.
- Children with a history of bleeding on brushing typical signs and symptoms of gingivitis.
- Healthy child (ASA I).
- Eruption of upper and lower permanent central and lateral incisors.
- Parent's agreement to sign the informed consent.
- Parent's ability for attending follow up visits.
Exclusion Criteria:
- Children -allergic to Chlorhexidine or Hyaluronic acid.
- Children with special health care needs or having a history of serious systemic disease that may affect the gingival health.
- Use of Systemic NSAIDs, steroids, or antibiotics within a month before the study.
- Children undergoing orthodontic treatment or having an intra-oral prosthesis.
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 |
|---|---|
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실험적: Hyaluronic acid mouthwah
Participants in the experimental group will use a hyaluronic acid mouthwash (Q-Afta®, CIRA Pharma, Egypt).
The principle investigator will instruct each participant to rinse with 10 mL of the mouthwash for 30-60 seconds twice daily after toothbrushing for a period of 14 days.
And also not to swallow the mouthwash and to avoid eating or drinking for 30 minutes after rinsing
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Q-Afta®, CIRA Pharma, Egypt
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활성 비교기: Chlorohexidine mouthwash
Participants in the control group will use a chlorohexidine mouthwash (Hexitol).
The principle investigator will instruct each participant to rinse with 10 mL of the mouthwash for 30-60 seconds twice daily after toothbrushing for a period of 14 day and not to swallow the mouthwash and to avoid eating or drinking for 30 minutes after rinsing.
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Hexitol®, 0.12% chlorhexidine gluconate; Arab Drug Company
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Taste acceptance
기간: After 14 days of mouthwash administeration
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Taste acceptance will be assessed using a visual analog scale (VAS) of faces, rated from 1 to 5, where 1 represents very bad taste, and 5 represents very good taste
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After 14 days of mouthwash administeration
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Gingival index
기간: At baseline before the study and after 14 days
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Gingival health will be measured by Löe & Silness gingival index
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At baseline before the study and after 14 days
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Plaque index
기간: At baseline before the study and after 14 days
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Plaque index will be measured by Löe & Silness plaque index
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At baseline before the study and after 14 days
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공동 작업자 및 조사자
스폰서
수사관
- 연구 책임자: Ola M Omar, Professor, Cairo University
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- Mouthwashes for children-2026
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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