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A Comprehensive Oral Health Intervention Program for Preschool and Primary School Children in Suzhou

2026年9月7日 更新者:Jieyun Yin、Soochow University

This study aims to evaluate the effectiveness of a comprehensive oral health intervention program among preschool and primary school children in Suzhou, China.

Preschools and primary schools in selected districts of Suzhou will be assigned to intervention or control groups. Children in the intervention group will receive a comprehensive oral health program involving oral health education, toothbrushing and rinsing instruction and practice, school- and family-based behavioral support, oral health promotion materials, and interactive educational activities. Children in the control group will receive basic oral health education and educational materials.

Oral health examinations, anthropometric assessments, questionnaires, and other follow-up assessments will be conducted to evaluate changes in dental caries, oral hygiene, gingival health, oral health-related knowledge, and oral health behaviors. Participants will be followed for up to three years after the baseline assessment.

調査の概要

状態

まだ募集していません

条件

詳細な説明

Dental caries is an important oral health problem among children. This study is designed to establish and evaluate an integrated oral health management model involving children, families, schools, and healthcare institutions.

The study will be conducted in selected districts of Suzhou, China, and will include children attending participating preschools and primary schools. Preschool children in the first year of kindergarten and first-grade primary school students will be invited to participate.

Participating schools will be allocated to an intervention group or a control group. The intervention group will receive a comprehensive oral health intervention consisting of oral health education, toothbrushing and rinsing instruction and practice, audiovisual educational materials, school-based oral health promotion, family involvement, behavioral reinforcement, and interactive or gamified oral health activities. The control group will receive basic oral health education and educational materials.

At baseline and during follow-up, oral health examinations will be conducted to assess dental caries and other oral health indicators. Additional assessments may include plaque status, gingival health, anthropometric measurements, questionnaires regarding oral health knowledge and behaviors, and collection of oral microbial samples.

Participants will be followed longitudinally for three years to evaluate the effectiveness of the comprehensive intervention in improving children's oral health and oral health-related behaviors.

研究の種類

介入

入学 (推定)

2040

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

  • 名前:Jieyun Yin, Ph.D.
  • 電話番号:+86 0512 6588036
  • メール:jyyin@suda.edu.cn

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子

健康ボランティアの受け入れ

はい

説明

Inclusion Criteria:

  • Children in participating preschools or primary schools in selected districts of Suzhou, China.
  • Children in the first year of preschool or the first grade of primary school at baseline.
  • Written informed consent provided by a parent or legal guardian.

Exclusion Criteria:

  • Children with severe systemic diseases were excluded.
  • Children who could not cooperate with the oral examination were excluded.
  • Children who transferred/moved out during the expected follow-up period were excluded.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:防止
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
介入なし:Basic Oral Health Education
実験的:Comprehensive Oral Health Intervention

The comprehensive intervention includes:

Oral health education delivered through lectures, classroom activities, videos, and educational materials.

Instruction and practice in appropriate toothbrushing and mouth-rinsing techniques.

Supervision and reinforcement of oral hygiene behaviors by teachers and parents.

Oral health educational materials, including posters, brochures, tooth models, and audiovisual materials.

Interactive and gamified oral health activities. Behavioral reinforcement activities, such as oral hygiene practice and oral health check-in activities.

Family-based oral health education and behavioral support. School-based oral health promotion activities.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
dmft/DMFT
時間枠:From enrollment to the end of treatment at 3 years

Dental caries: DMFT/dmft index D/d: crown with obvious caries, or softening of the bottom wall of the cavity, or filled due to caries (including secondary caries).

M/m: loss due to caries (permanent teeth) or early loss due to caries (primary teeth).

F/f: filling due to caries without secondary caries.

From enrollment to the end of treatment at 3 years

二次結果の測定

結果測定
メジャーの説明
時間枠
Gingival Index
時間枠:From enrollment to the end of treatment at 3 years

The color, texture, and bleeding tendency of the gums were observed by probing, and the gingival condition of each tooth was rated as 0-3 points (subjective judgment of the doctor).

Methods: A blunt tip periodontal probe was used, combined with visual examination and probing. The kindergartners selected 4 representative teeth: 51, 61, 75, 85, and the primary students selected 6 representative teeth: 16, 21, 24, 36, 41, 44 (if the representative teeth were not erupted, they were replaced by the adjacent erupted teeth). Each tooth was examined at 4 sites and the average score was recorded.

Scoring criteria:

Score 0: healthy gums with no inflammation and no bleeding on probing. Score 1: mild inflammation (slight change in color and texture) without bleeding on probing.

Score 2: moderate inflammation (redness, edema, light), bleeding on probing. Score 3: severe inflammation (marked redness, hypertrophy, or ulceration) with a tendency to spontaneous bleeding.

From enrollment to the end of treatment at 3 years
Plaque Index
時間枠:From enrollment to the end of treatment at 3 years

he dentist applied plaque stain (2% basic fuchsin solution or children's specific erythraea red tablet) to the entire tooth surface, waited 30 seconds, rinsed the mouth with water for 30 seconds, then observed the stained plaque attachment area, and scored according to the tooth surface area (kindergartners examined 4 index teeth: 51, 61, 75, 85, primary school students examined 6 teeth: 16, 21, 24, 36, 41, 44) (if the representative tooth has not yet erupted, it will be replaced by the adjacent erupted tooth), 0-3 points (subjective judgment of doctors) Methods: Smear the whole tooth surface with plaque display agent, gargle with water, and observe the stained area. Each tooth was examined on four tooth surfaces, and the average score was recorded.

Scoring criteria:

Score 0: no plaque in the gingival margin area. Score 1: The tip of the probe gently scratched the tooth surface, and a small amount of plaque was observed (not visible to the naked eye).

Score 2: moderate amount of

From enrollment to the end of treatment at 3 years
Scale index
時間枠:From enrollment to the end of treatment at 3 years

The scale coverage area of the teeth was evaluated by visual inspection, and the cleaning effect of daily brushing was quickly determined. Six designated tooth surfaces were examined: 16 buccal, 11 labial, 26 buccal, 31 labial, 36 lingual, and 46 lingual. Kindergarten-aged children were simplified to 4 primary teeth (51, 61, 75, 85).

0 point: no soft scale and no exogenous pigmentation on the tooth surface

  1. point: the scale covered less than 1/3 of the tooth surface; Or no soft dirt but the presence of pigment stains
  2. points: the soft scale covered 1/3 to 2/3 of the tooth surface
  3. points: soft scale covering > 2/3 of the tooth surface (a large amount of food debris accumulation) Total score ÷6 = individual mean soft scale index DI-S
From enrollment to the end of treatment at 3 years

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年10月8日

一次修了 (推定)

2029年6月30日

研究の完了 (推定)

2029年6月30日

試験登録日

最初に提出

2026年8月18日

QC基準を満たした最初の提出物

2026年9月7日

最初の投稿 (実際)

2026年9月8日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月10日

QC基準を満たした最後の更新が送信されました

2026年9月7日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • 86560320

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

IPD プランの説明

Individual participant data (IPD) will not be made publicly available. The study involves pediatric participants, and the collected oral health data may include potentially sensitive individual-level clinical and demographic information. Although study data will be de-identified for analysis, sharing individual-level data outside the study team may still pose a potential risk of re-identification, particularly given the involvement of minors. In addition, external sharing of individual participant data is not covered by the current informed consent and/or ethics approval. Therefore, only aggregated study results will be reported or published, and no individual participant dataset will be publicly shared.

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いいえ

米国FDA規制機器製品の研究

いいえ

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