Cost-efficacy Between ART and Composite Resin Restorations in Primary Molars
Difference of Cost-efficacy Between Atraumatic Restoration Treatment (ART) and Composite Resin Restorations in Primary Molars: A Randomized Clinical Trial
調査の概要
詳細な説明
Research setting
The study will be performed in a dental care trailer which simulated a regular dental office and it is located inside a public school of the city Barueri (São Paulo, Brazil).
Sample size calculation
For sample size calculation, data regarding longevity of CT in occlusal and occlusoproximal restorations after 2 years were extracted from the literature as 86% for occlusal and 60% for occlusoproximal restorations. A difference of 15% and 20% between the longevity of CT and ART was set as non-inferiority limit. Considering the level of significance as 5%, power as 80% and adding 40% due to the study design (cluster per child), a number of 204 occlusal restorations and 240 occlusoproximal restorations will be needed.
Randomization
The child will be the unit of randomization which means that all eligible teeth of a participant will be treated according the same restorative approach. Randomization list will be obtained using blocks of 4, 6 and 8 generated by software Sealed Envelope Ltd. Opaque, sealed and sequentially numbered envelopes will be used for randomizing all participants immediately before restorative treatments' beginning.
Allocation concealment
To assure allocation concealment, the participant will be randomized immediately before the treatment. When two or more cavities is available, preventing the finalization of the treatment in only one session, breach of allocation concealment will be signalized in the participants' record.
Blinding
Due to differences between the techniques, it will be not possible to blind operators, participants and evaluators.
Operators
All operators will be masters or PhD students from the Pediatric Dentistry Department, Faculty of Dentistry, University of São Paulo, previously trained. All procedures will be performed with the assistance of a dental student previously trained to manipulate all restorative materials.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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São Paulo
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Barueri、São Paulo、ブラジル
- Complexo Educacional Carlos Osmarinho de Lima - Trailer USP
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Children aging between 3 and 6 years
- presenting good health conditions
- whose parents or legal guardians accept and sign the consent form
- with at least one occlusal or occlusal proximal caries lesion in primary molars
- only occlusal and/or occlusal-proximal surfaces with caries lesions with dentin involvement
Exclusion Criteria:
- severe behavioral issues
- presence of fistula or abscess near the selected tooth
- presence of pulp exposure in the selected tooth
- presence of mobility in the selected tooth
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：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：Conventional Treatment
Occlusal and occlusoproximal composite resin restorations in primary molars (rubber dam isolation + Adhesive system + composite resin Filtek z350)
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Occlusal and occlusoproximal composite resin restorations in primary molars using the Scotchbond Multi-purpose adhesive system and the Filtek Z-350 composite resin wil be performed.
Local anesthesia will be used.
Absolute isolation will be performed using rubber dam and clamp.
Removal of unsupported enamel will be performed using a round bur.
Infected carious tissue will be removed with hand instruments.
The cavity will be etched using 37% phosphoric acid for 15 seconds followed by rising and drying for the same amount of time.
The cavity will be restored with composite resin.
Occlusion will be checked.
an adapted matrix strip with a wooden wedge will be used to assure appropriate contour.
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実験的：ART using Fuji IX
Occlusal and occlusoproximal ART restorations in primary molars with GIC Fuji IX
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Occlusal and occlusoproximal ART restorations in primary molars using the high viscosity GIC Fuji IX will be performed under relative isolation.
No local anesthesia will be used.
Infected carious tissue will be removed with hand instruments, and the cavities restored with GIC.
After the press-finger technique, the excess of material will be removed and occlusion will be checked.
For occlusoproximal restoration, an adapted matrix strip with a wooden wedge will be used to assure appropriate contour.
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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 |
|---|---|---|
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The restoration survival
時間枠：Every 6 months up to 24 months.
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The treatments will be classified as successful when they present a clinical satisfactory aspect.
Otherwise, "minor failures" will be analyzed.
"Minor failures" are those in which there is a defect in the restoration/crown, but it does not interfere with the tooth health.
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Every 6 months up to 24 months.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Cost-efficacy assessment
時間枠：Through study completion, an average of 24 months
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Treatment costs = professional costs + procedure costs.
If the restorative treatment requires repairs, the additional cost of it will also be considered. |
Through study completion, an average of 24 months
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Child self-reported discomfort
時間枠：Immediately after treatment
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The acceptability of each type of treatment will be evaluated using the Facial scale of Wong-Baker (Wong; Baker, 1998).
This scale indicates the discomfort of an individual who has to choose among six faces, each one expressing different facial countenance.
The first image is a smiling happy face, indicating no discomfort, followed by gradually less cheerful expressions, up to the last one which is a very sad face covered by tears, indicating great discomfort.
The participant will be asked to choose the face that is more similar to how he or she felt during the treatment.
This answer should be given solely by the child, which means, no parental or professional interferences.
The facial scale of Wong-Baker will be applied right after the end of each restorative treatment session.
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Immediately after treatment
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Cooperation
時間枠：Immediately after treatment
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Cooperation will be evaluated by the operator immediately after the end of the treatment using a 5-point scale: 1- Good behaviour, 2- Reasonable behaviour, 3- Indiferent, 4- Bad behaviour, 5- Really bad behaviour.
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Immediately after treatment
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協力者と研究者
スポンサー
捜査官
- スタディチェア：Daniela P Raggio, PhD、University of Sao Paulo
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 (実際)
一次修了 (実際)
研究の完了 (予想される)
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 (見積もり)
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
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