Efficacy of Lasers, Propolis-Based Agent, and Sham for Dentine Hypersensitivity
Comparison of Nd:YAG Laser, Diode Laser, Herbal Propolis-Based Dentin Barrier Agent, and Sham Application in the Treatment of Dentine Hypersensitivity: A Randomized Controlled Clinical Trial
調査の概要
状態
条件
詳細な説明
This study was conducted as a prospective, randomized, parallel-arm, evaluator-blinded, sham-controlled clinical trial to evaluate and compare the clinical efficacy of four different treatment modalities for dentine hypersensitivity over a 6-month follow-up period.
A total of 140 patients who met the eligibility criteria were enrolled and randomly allocated into four equal groups (n=35 per group) using a block randomization method with a 1:1:1:1 allocation ratio. The intervention groups were assigned as follows:
Group 1 received Nd:YAG laser application.
Group 2 received Diode laser application.
Group 3 received a topical application of a herbal propolis-based dentin barrier agent.
Group 4 received a sham (placebo) application to simulate the treatment experience without delivering any active laser or therapeutic agent benefits.
Clinical evaluations were performed at baseline, immediately post-treatment, 1 week, 1 month, 3 months, and 6 months. The primary outcome was the change in pain intensity measured by the Visual Analog Scale (VAS) following a controlled air blast stimulus from baseline to 6 months. Secondary outcomes included changes in the Schiff Cold Air Sensitivity Scale, tactile sensitivity scores, patient satisfaction levels, the documentation of any adverse events, and the need for additional treatment during the 6-month period. To ensure objectivity, all clinical assessments and statistical analyses were performed by researchers who were fully blinded to the treatment allocations.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Samsun
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Samsun、Samsun、トルコ（Türkiye）、55270
- Ondokuz Mayıs University, Faculty of Dentistry, Department of Periodontology
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Patients aged between 18 and 65 years.
- Presence of at least two hypersensitive teeth.
- Visual Analog Scale (VAS) score of 4 or higher (VAS >= 4) following stimulus.
- Schiff Cold Air Sensitivity Scale score of 2 or higher (Schiff >= 2).
- Presence of vital teeth in the target area.
- Patient is willing and able to provide written informed consent prior to study initiation.
Exclusion Criteria:
- Pregnancy or lactation.
- Presence of active periodontal disease in the target area.
- Teeth with dental caries, deep restorations, or cracked tooth syndrome.
- Endodontically treated teeth.
- History of allergy or hypersensitivity related to the materials, products, or chemical agents used in the study.
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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実験的：Group 1: Nd:YAG Laser
Participants assigned to this group received Nd:YAG laser application targeted at the hypersensitive teeth to achieve desensitization.
The procedure was completed during the treatment session according to the clinical protocol.
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Nd:YAG laser application performed for the treatment of dentine hypersensitivity.
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実験的：Group 2: Diode Laser
Participants assigned to this group received Diode laser application on the affected dentine areas for hypersensitivity treatment.
The application was performed in accordance with the specified parameters.
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Diode laser application performed for the treatment of dentine hypersensitivity.
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実験的：Group 3: Dentin Barrier Agent
Participants assigned to this group received a topical application of a herbal propolis-based dentin barrier agent onto the hypersensitive tooth surfaces.
The agent was applied to seal the dentinal tubules and reduce sensitivity.
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Topical application of a herbal propolis-based dentin barrier agent.
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偽コンパレータ：Group 4: Sham Application
Participants assigned to this group received a sham (placebo) procedure designed to completely simulate the laser or topical application experience without delivering any active laser energy or therapeutic desensitizing agent.
This group served as the control to account for the placebo effect.
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Placebo/sham procedure to simulate treatment without delivering active laser or therapeutic agent benefits
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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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Change in Visual Analog Scale (VAS) Score after Air Stimulus
時間枠：Baseline and 6 months
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Pain intensity evaluated using the Visual Analog Scale (VAS), where scores range from 0 (no pain) to 10 (extreme/worst pain).
The primary outcome is defined as the change in pain intensity in response to a controlled air blast stimulus from baseline to 6 months.
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Baseline and 6 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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Schiff Cold Air Sensitivity Scale Score
時間枠：Baseline, immediately post-treatment, 1 week, 1 month, 3 months, and 6 months
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Dentine sensitivity assessed using the Schiff Cold Air Sensitivity Scale, where scores range from 0 (patient does not respond to air stimulus) to 3 (patient responds to air stimulus, experiences pain, and requests discontinuation of stimulus).
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Baseline, immediately post-treatment, 1 week, 1 month, 3 months, and 6 months
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Tactile Sensitivity Score
時間枠：Baseline, immediately post-treatment, 1 week, 1 month, 3 months, and 6 months
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Tactile sensitivity evaluated using a standard dental explorer probe passed across the affected dentine surface to record the presence or absence of discomfort or pain.
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Baseline, immediately post-treatment, 1 week, 1 month, 3 months, and 6 months
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協力者と研究者
スポンサー
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 (実際)
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
- 2025000326-2
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
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