Bioactive Materials in Vital Pulp Therapy of Permanent Teeth
Evaluation of the Effect of Two Different Bioactive Materials on the Success of Vital Pulp Therapy in Permanent Teeth: A Prospective Clinical Study
This randomized clinical study aimed to evaluate and compare the clinical, radiographic, and postoperative pain outcomes of direct pulp capping performed using two calcium silicate-based materials: ProRoot MTA and Biofactor MTA in permanent teeth with vital pulp exposure.
A total of 80 teeth were randomly allocated into two groups according to the capping material used. Following standardized caries removal and achievement of hemostasis, direct pulp capping was performed using either ProRoot MTA or Biofactor MTA under similar clinical conditions. Definitive coronal restorations were completed 24 hours after the procedure.
Postoperative pain was assessed using a numerical rating scale (NRS) at 0, 6, 12, 24, and 48 hours after treatment. Patients were instructed to record their pain levels and analgesic intake during this period.
Patients were recalled for clinical and radiographic evaluations at 6 and 12 months. Clinical success was defined as the absence of spontaneous pain, sensitivity, swelling, sinus tract formation, and tenderness to percussion or palpation. Radiographic success was determined by the absence of periapical pathology.
Additionally, the influence of demographic and clinical variables, including age, gender, characteristics of pulp exposure, and intraoperative factors, on treatment outcomes and pulpal healing was evaluated.
調査の概要
状態
条件
詳細な説明
This randomized controlled clinical study was designed to evaluate and compare the clinical performance, radiographic outcomes, postoperative pain, and pulpal healing following direct pulp capping using two calcium silicate-based materials: ProRoot MTA and Biofactor MTA in permanent teeth with vital pulp exposure.
A total of 80 teeth diagnosed with vital pulp requiring direct pulp capping were included in the study. Participants were randomly allocated into two equal groups (n=40) according to the pulp capping material used. All procedures were carried out under standardized clinical conditions.
Caries removal was performed using a sterile round diamond bur under water cooling, followed by excavation with a spoon excavator. Teeth with pulp exposure were included in the study. Hemostasis was achieved. In cases where bleeding could not be controlled within a clinically acceptable time, the tooth was excluded from the study.
In the experimental group, Biofactor MTA was applied directly over the exposed pulp tissue according to the manufacturer's instructions. In the control group, ProRoot MTA was used following the same protocol. After placement of the capping material, a protective base was applied, and the cavity was temporarily restored. Definitive coronal restorations were completed 24 hours after the initial procedure.
Postoperative pain was evaluated using a Numerical Rating Scale (NRS) at 0, 6, 12, 24, and 48 hours following treatment. Patients were instructed to record their pain intensity and the number of analgesic tablets taken during this period.
Patients were recalled for follow-up examinations at 6 and 12 months. Clinical evaluation included assessment of spontaneous pain, sensitivity, swelling, sinus tract formation, tenderness to percussion and palpation, and periodontal probing depths. Radiographic evaluation was performed to assess the presence of periapical pathology.
Treatment success was defined as the absence of clinical symptoms and the absence of radiographic signs of pathology.
Furthermore, the influence of demographic and clinical variables, including age, gender, number and location of pulp exposures, size of exposure, and bleeding control time, on treatment outcomes was analyzed.
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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Izmir、トルコ（Türkiye）、35100
- Ege University Faculty of Dentistry
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参加基準
適格基準
就学可能な年齢
- 子
- 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 13 and 65 years
- Patients with adequate patient-clinician communication
- Patients who agree to attend periodic follow-up visits throughout the study
- Patients who provide written informed consent to participate in the study
- Systemically healthy patients
- Teeth with no previous endodontic treatment
- Teeth showing a positive response to cold and electric pulp test
- Permanent teeth
- Posterior teeth
- Teeth that can be restored with direct composite restoration
- Teeth with pulp exposure (pulpal perforation)
- Presence of bleeding from the exposed pulp that can be controlled within 5-10 minutes
Exclusion Criteria:
- Patients who refuse to participate in the study
- Medically compromised patients (e.g., patients with systemic diseases, immunological disorders, or those using medications)
- Patients with known allergies to materials used during vital pulp therapy
- Pregnant patients
- Non-vital teeth
- Presence of advanced periodontal disease (probing depth > 3 mm)
- Teeth with previous endodontic treatment
- Teeth with insufficient remaining tooth structure that cannot be restored with restorative materials
- Teeth where adequate isolation cannot be achieved
- Teeth requiring post core restoration
- Patients in whom periapical radiographs cannot be obtained
- Patients unable to attend follow-up visits
- Cases in which bleeding from the exposed pulp cannot be controlled within 5-10 minutes
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：なし（オープンラベル）
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：ProRoot MTA
In this group, direct pulp capping procedures were performed using ProRoot MTA.
Following caries removal under water cooling with a sterile round diamond bur and spoon excavator, teeth with pulp exposure were included in the study.
Hemostasis was achieved.
ProRoot MTA was then placed directly over the exposed pulp tissue according to the manufacturer's instructions.
A protective base was applied over the material, and the cavity was temporarily restored.
Definitive coronal restoration was completed 24 hours after the procedure.
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Direct pulp capping was performed using ProRoot MTA after caries removal and hemostasis.
The material was placed over the pulp exposure, and definitive restoration was completed after 24 hours.
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実験的：BIOfactor MTA
In this group, direct pulp capping procedures were performed using BIOfactor MTA.
Following caries removal under water cooling with a sterile round diamond bur and spoon excavator, teeth with pulp exposure were included in the study.
Hemostasis was achieved.
BIOfactor MTA was placed over the exposure site in accordance with the manufacturer's recommendations.
A protective base material was applied, and temporary restoration was performed.
Permanent coronal restoration was completed 24 hours later.
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Direct pulp capping was performed using Biofactor MTA following caries removal and hemostasis.
The material was applied directly over the exposed pulp, and definitive restoration was completed after 24 hours.
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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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Clinical and radiographic success of direct pulp capping
時間枠：1 year follow-up
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Treatment success defined as the absence of clinical symptoms, including spontaneous pain, sensitivity, swelling, sinus tract formation, and tenderness to percussion or palpation, together with the absence of radiographic signs of pathology such as periapical radiolucency.
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1 year follow-up
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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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Postoperative pain intensity following direct pulp capping
時間枠：up to 2-day
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Postoperative pain will be evaluated using a Numerical Rating Scale (NRS), where patients rate their pain intensity at predefined time intervals after treatment.
The Numerical Rating Scale is a pain measurement scale that encompasses the following grades: 0 no pain, 1-3 mild pain, 4-6 moderate pain, 7-10 severe pain.
Patients will be instructed to record their pain levels and analgesic intake.
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up to 2-day
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Gözde Kandemir Demirci, Associate Professor、Ege University Faculty of Dentistry
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
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 24-3.1/5
- 32695 (その他の助成金/資金番号：Ege University Scientific Research Projects Coordination Unit (BAP))
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?
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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