Laser Assisted Pulpotomy Versus MTA Pulpotomy in Permanent Teeth With Irreversible Pulpitis
Comparative Evaluation of Diode Laser-Assisted Pulpotomy Versus MTA Pulpotomy in Permanent Teeth With Irreversible Pulpitis: A Randomized Clinical Trial
This study compares two methods used during full pulpotomy, a treatment for teeth with deep tooth decay that has exposed the dental pulp.
In the first method, the dentist removes the affected pulp tissue using a high-speed dental bur and then controls the bleeding using a sodium hypochlorite solution.
In the second method, the dentist also removes the affected pulp tissue using a high-speed dental bur, but a diode laser is used to control the bleeding. The laser may provide additional disinfection and achieve bleeding control more quickly.
After treatment, participants will be monitored to assess their level of pain relief. They will also return for follow-up visits at 6 months and 12 months, when dental X-rays will be taken to evaluate the success of the treatment.
調査の概要
詳細な説明
Vital pulp therapy (VPT) is a minimally invasive treatment that aims to preserve the vitality and function of the dental pulp after exposure caused by deep caries. Compared with root canal treatment, VPT preserves the remaining healthy pulp tissue, allowing the tooth to maintain its natural defense mechanisms and reparative capacity. Full pulpotomy has become an accepted treatment option for permanent teeth with carious pulp exposure when the radicular pulp is considered healthy and capable of healing. Clinical studies have demonstrated high success rates for full pulpotomy in appropriately selected cases.
Successful pulpotomy depends on adequate removal of the inflamed coronal pulp tissue, effective control of pulpal bleeding, reduction of bacterial contamination, and placement of a suitable biocompatible pulp-capping material. Conventionally, hemostasis is achieved using sodium hypochlorite following removal of the coronal pulp tissue with a high-speed bur. Although this technique has demonstrated favorable outcomes, alternative methods that may improve hemostasis and enhance tissue healing continue to be investigated.
Diode lasers have been increasingly used in dentistry for soft tissue procedures because of their ability to provide precise tissue interaction, coagulation, and effective hemostasis. In addition to controlling bleeding, diode lasers have antimicrobial properties and may promote wound healing through biostimulatory effects that support tissue repair and reparative dentin formation. These characteristics suggest that diode laser-assisted pulpotomy may offer clinical advantages over the conventional technique.
Despite the increasing use of diode lasers in dentistry, clinical evidence regarding their use in full pulpotomy of permanent teeth with carious pulp exposure remains limited. Most published studies have evaluated diode laser pulpotomy in primary teeth or animal models, and randomized clinical trials in permanent teeth are lacking.
This randomized clinical trial is designed to compare diode laser-assisted full pulpotomy with the conventional full pulpotomy technique in permanent teeth with carious pulp exposure. In both study groups, the coronal pulp tissue will be removed using a conventional high-speed bur. In the control group, hemostasis will be achieved using sodium hypochlorite. In the experimental group, a diode laser will be used to achieve hemostasis following pulp removal. The same pulp-capping material and definitive restoration protocol will be used in both groups to ensure that the method of achieving hemostasis is the primary variable under investigation.
Participants will be evaluated for postoperative pain following treatment. Clinical and radiographic outcomes will be assessed at 6 and 12 months to determine treatment success. The study aims to determine whether diode laser-assisted full pulpotomy provides clinical and radiographic outcomes comparable to or better than those of the conventional technique.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
-
-
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Irbid、ヨルダン、3030
- Jordan University of Science and Technology
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-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
• Non -contributory medical history (SAI, II).
- Premolar or Molar permanent tooth
- Age range 10-60 years
- Deep caries extending>= 2/3 of dentin or exposing the pulp on the radiograph
- The tooth should give positive response to cold sensibility testing
- Clinical diagnosis of irreversible pulpitis based on the symptoms and results of cold testing.
- The tooth is restorable, probing pocket depth and mobility are within normal limits
- No signs of pulpal necrosis including sinus tract or swelling
Exclusion Criteria:
Medically compromised patient.
- Non-restorable tooth.
- Signs of pulpal necrosis including sinus tract or swelling.
- No enough bleeding after the pulpotomy procedure.
- Inability to achieve hemostasis within 10 min after the pulpotomy.
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：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Full pulpotomy using diode laser for hemostasis
Diode laser used after the full pulpotomy to achieve hemostasis following cutting of the pulp tissue.
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The use of diode laser to achieve hemostasis after cutting the coronal part of the pulp tissue which is present in the tooth crown, down to the level of the canal orifices.
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アクティブコンパレータ：Full pulpotomy using sodium hypochlorite for hemostasis
The use of sodium hypochlorite to achieve hemostasis after cutting the pulp tissue to th level of root canal orifices
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The use of Sodium hypochlorite to achieve hemostasis after full pulpotomy
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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 |
|---|---|---|
|
Postoperative pain after pulpotomy
時間枠：One week after treatment
|
Postoperative pain will be assessed using an 11-point Numeric Rating Scale (NRS), where 0 indicates "no pain" and 10 indicates "the worst pain imaginable."
Participants will record their pain intensity at the prespecified postoperative time points.
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One week after treatment
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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 |
|---|---|---|
|
Success of pulpotomy
時間枠：Six and 12 months after treatment
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Clinical and radiographic success will be evaluated at the follow-up visits.
Clinical success is defined as the absence of spontaneous pain, tenderness to percussion, swelling, sinus tract, pathological mobility, or other signs and symptoms indicating pulpal or periapical disease.
Radiographic success is defined as the absence of periapical radiolucency, furcation involvement, external or internal root resorption, widening of the periodontal ligament space, or other radiographic evidence of treatment failure.
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Six and 12 months after treatment
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Tooth survival
時間枠：12 months after treatment
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Tooth survival will be defined as the percentage of treated teeth remaining in the mouth and functioning without extraction during the follow-up period, regardless of the radiographic findings as far as the tooth is asymptomatic.
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12 months after treatment
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協力者と研究者
捜査官
- スタディチェア：Nessrin Taha, PhD、Jordan University of Science and Technology
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 (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
キーワード
その他の研究ID番号
- 510/2025
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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