Effectiveness of Single and Dual Silver Fluoride Application
The Effectiveness of Single and Dual Silver Fluoride (SF) Applications on Dentine Caries Among Malaysian Preschool Children: A Randomised Controlled Trial
This is a community-based, parallel-group, double-blinded randomised controlled trial aimed at evaluating the effectiveness of single and dual applications of 38% Silver Fluoride (SF) in arresting dentinal caries among Malaysian preschool children aged 4 to 6 years.
The main questions this study aims to answer are:
i) Does dual application of 38% Silver Fluoride differ from single application in arresting dentinal caries lesions after 6 months? ii) How does SF application influence oral health-related quality of life (OHRQoL) among preschool children, as measured by the Malay-ECOHIS questionnaire? iii) Is there a correlation between caries arrest and changes in Oral Health-Related Quality of Life (OHRQoL) measured using the Malay-ECOHIS questionnaire?
Researchers will compare children receiving a single application of 38% Silver Fluoride with those receiving dual applications to determine whether more frequent application improves caries arrest outcomes.
Participants will:
i) Undergo oral examination for assessment of dentinal caries using ICDAS criteria.
ii) Receive 38% Silver Fluoride application at baseline, with the dual-application group receiving an additional application at 3 months.
iii) Attend follow-up assessments at 3 and 6 months to evaluate caries arrest status.
iv) Have parents or guardians complete the Malay-ECOHIS questionnaire to assess changes in OHRQoL.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ 3
連絡先と場所
研究連絡先
- 名前：Nor Azlida Mohd Nor (Associate Prof), BDS, MSc, PhD
- 電話番号：+6010-2716747
- メール：azlida@um.edu.my
研究連絡先のバックアップ
- 名前：Dr. Tengku Nurfarhana Nadirah Tengku Hamzah(Dr), BDS, MClinDent
- 電話番号：+6012-5250520
- メール：tengkunurfarhana@um.edu.my
研究場所
-
-
Perak
-
Tapah、Perak、マレーシア、35000
- Preschools in Perak
-
コンタクト：
- Mohamad Noor Sairi (Dr), BDS, MCOH, Doctorate
- 電話番号：016-7786161
- メール：dr.mohamadnoor@moh.gov.my
-
主任研究者：
- Nurfazlina Rosman (Dr), DDS, MCOH
-
副調査官：
- Mohamad Noor Sairi (Dr), BDS, MCOH, Doctorate
-
-
参加基準
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
説明
Inclusion Criteria:
- Children aged 4-6 years enrolled in selected preschools.
- Presence of at least one active dentinal caries lesion.
- Parental or guardian consent obtained.
- Asymptomatic cavitated dentine carious lesions in primary teeth.
- Parents/caregivers who understand the Malay language.
Exclusion Criteria:
- Clinical signs or symptoms of irreversible pulpitis or dental abscess/fistula.
- Systemic illness or medical contraindications for SF use.
- Developmental abnormalities of tooth structure, including amelogenesis imperfecta or dentinogenesis imperfecta.
- History of allergy or sensitivity to dental materials, including silver or fluoride contained in silver fluoride (SF).
- Children who have received professionally applied fluoride within the past six months at the time of recruitment.
- Arrested caries lesion.
- Children presenting with oral ulceration or mucositis.
- Uncooperative behaviour precluding oral examination.
- Children with pre-shedding tooth mobility
研究計画
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
プラセボコンパレーター：Single Application of Silver Fluoride
Single applications of 38% silver fluoride will be applied to dentinal carious lesions at baseline and followed by placebo (normal saline) at 3 months
|
Topical application of 38% silver fluoride will be apply onto dentinal caries lesions using a micro-brush at baseline and 3 months follow up.
One drop (0.05 mL) treats up to five surfaces.
Maximum dose per visit does not exceed 260 µL.
Participants receive a single application of 38% silver fluoride at dentinal carious lesion at baseline and followed by placebo (normal saline) at 3 months
|
|
実験的：Dual Application of Silver Fluoride
Two applications of 38% silver fluoride will be applied to dentinal carious lesions at baseline and 3 months.
|
Topical application of 38% silver fluoride will be apply onto dentinal caries lesions using a micro-brush at baseline and 3 months follow up.
One drop (0.05 mL) treats up to five surfaces.
Maximum dose per visit does not exceed 260 µL.
|
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 |
|---|---|---|
|
Caries arrest at tooth surface level
時間枠：6 months
|
Lesions are considered arrested if they are hard upon probing using WHO probe and have turned black in colour.
Each tooth may contribute up to five surfaces, with analysis conducted at the lesion level.
|
6 months
|
|
Proportion of arrested lesions
時間枠：6 months
|
Caries arrest will be assessed at the tooth surface level.
The outcome is defined as the proportion of lesions classified as arrested out of the total treated lesions in each group.
Comparisons will be made between single and dual application groups.
Analyses will be conducted at both surface (lesion) level and participant level, accounting for clustering of lesions within individuals.
|
6 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in OHRQoL (Malay-ECOHIS score)
時間枠：Baseline to 6 months
|
Change in total Malay-ECOHIS score from baseline to 6 months will be assessed.
The Malay-ECOHIS is a validated parent-reported questionnaire measuring the impact of oral health on children and their families.
Scores range from 0 to 52, with higher scores indicating worse oral health-related quality of life.
A reduction in score reflects improvement in OHRQoL.
|
Baseline to 6 months
|
|
To determine correlation between caries arrest rate and change in total Malay-ECOHIS score
時間枠：0-6 months
|
This outcome will assess the correlation between caries arrest rate at 6 months and change in total Malay-ECOHIS score from baseline to 6 months. Caries arrest rate (%) will be assessed by clinical examination and calculated as the number of arrested treated dentinal caries lesions divided by the total number of treated dentinal caries lesions per participant, multiplied by 100. The unit of measure is percentage (%) of arrested treated dentinal caries lesions. Change in total Malay-ECOHIS score will be assessed using the Malay-ECOHIS questionnaire. The change score will be calculated as the total score at 6 months minus the baseline total score. The unit of measure is change in total Malay-ECOHIS score. Pearson correlation will be used if normality assumptions are met; otherwise, Spearman rank correlation will be used. |
0-6 months
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Nor Azlida Mohd Nor (Associate Prof), BDS, MSc, PhD、Universiti Malaya
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- DF CO2505/0018 (P)
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?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。