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R. Officinalis as Pulpotomy Agent in Permanent Teeth With Irreversible Pulpitis

2026年5月21日 更新者:Zoha Nasir、University of Health Sciences Lahore

Comparative Clinical and Radiographic Evaluation of Rosmarinus Officinalis Versus Mineral Trioxide Aggregate as Pulpotomy Medicament in Vital Mature Permanent Teeth With Irreversible Pulpitis

This study evaluates and compares the clinical and radiographic outcomes of Rosmarinus officinalis and Mineral Trioxide Aggregate (MTA) when used as pulpotomy medicaments in vital mature permanent teeth with irreversible pulpitis. The aim is to determine the effectiveness of both materials in terms of pain reduction and periapical healing. While MTA is considered a gold standard, it has limitations such as high cost, long setting time, and potential discoloration. Therefore, this study investigates Rosmarinus officinalis as a natural, cost-effective alternative with comparable therapeutic potential. This study also provide an alternative to RCT in teeth with irreversible pulpitis

調査の概要

詳細な説明

Traditionally, teeth with irreversible pulpitis have been treated either by root canal therapy or extraction, yet root canal treatment, although considered the gold standard, still presents limitations because it is technique-sensitive, invasive, time-consuming, and costly. To address these issues, more affordable and minimally invasive alternatives are being explored. With better understanding of the regenerative and healing abilities of inflamed pulp, along with the development of biologically active materials, vital pulp therapy is now increasingly viewed as a suitable alternative for managing irreversible pulpitis. Mineral trioxide aggregate is widely accepted as the current gold standard, but its drawbacks-including high cost, extended setting time and potential tooth discoloration-remain significant concerns. As a result, newer materials are being evaluated that are more cost-effective while avoiding these disadvantages.

One such material, Rosmarinus officinalis, has been used in vital pulp therapy of primary molars and has shown promising results. Despite the documented antimicrobial and anti-inflammatory properties of R. officinalis, its use as a pulpotomy agent in permanent teeth with irreversible pulpitis has not yet been investigated. This study aims to compare the outcomes of pulpotomy treatment using R. officinalis extract both clinically and radiographically versus MTA. This may help provide an alternative to RCT and a more economical option than MTA, while aiming for comparable effectiveness and addressing the limitations associated with MTA. Healthy young adults exhibiting signs and symptoms of irreversible pulpitis in at least one permanent posterior tooth, showing no periapical radiolucency in a periapical x-ray, along with the absence of swelling or sinus tract formation will be selected. Only the teeth with hemostasis achieved following the removal of coronal pulp will be included.

A randomized control trail will be conducted, wherein participants will be randomly assigned, using lottery method, to two groups, each consisting of 50 individuals of age 18-40 years of both sexes. After administration of anesthesia and isolation using a rubber dam, a sterile diamond round bur in a high-speed handpiece with water spray will used to remove enamel caries and carbide round bur in slow speed handpiece is used to remove dentinal caries. After the access opening, the coronal pulp will be removed up to the level of the canal orifice using a spoon excavator. After rinsing with sterile saline, hemostasis will be achieved by placing damp cotton soaked in saline. For group A, cotton will be dipped in R-officinalis extract, and placed over radicular pulp for 5 minutes and the pulp chamber will be sealed with a thick paste of aqueous R. officinalis extract with zinc oxide powder and for group B, white MTA will be prepared according to the manufacturer's instructions and placed in the pulp chamber compacted with a damp cotton pellet. Both will be restored with glass ionomer followed by direct composite. An immediate post-op periapical x-ray will be exposed. For clinical and radiographical evaluation patients will be recalled for follow-up at 1 week, 3 month and 6 months. Statistical analysis will be performed at the significance level of p= 0.05.

研究の種類

介入

入学 (推定)

100

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

    • Punjab Province
      • Lahore、Punjab Province、パキスタン、54000
        • Punjab Dental Hospital, Lahore .

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria

  • Healthy patients (ASA classification 1 and 2) of age range of 18-40 of both sexes would be included.
  • Vital mature permanent posterior teeth with deep caries approaching the pulp as seen on periapical x-ray.
  • Pain indicative of irreversible pulpitis (spontaneous pain or pain exacerbated by a cold stimulus which could last from a few seconds to hours), which a cold test could reproduce.
  • Tooth will be selected on the basis of working diagnosis i.e. successful hemostasis within 5 minutes after removal of coronal pulp.
  • Absence of clinical signs or symptoms suggesting a non-vital tooth such as tenderness to percussion or palpation, mobility, presence of abscess, soft tissue swelling or suppurating sinus.
  • Absence of radiographic changes as; furcation or periapical pathology, internal or external root resorption or calcification in the canals.
  • The tooth structure of selected teeth should be restorable after completion of the treatment

Exclusion Criteria:

  • Patients with ASA classification 3, 4 ,5 and 6 would be
  • Patients taking antibiotics within last 2 weeks.
  • Teeth with pulp necrosis, cracked tooth, internal or external resorption, calcified canals, acute or chronic apical periodontitis with an associated sinus tract or periapical radiolucency.
  • Periodontally compromised tooth.
  • Uncooperative patients or failure to obtain authorization from patients.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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
アクティブコンパレータ:Control Group with MTA pulpotomy
Pulpotomy Medicaent in control group
MTA shall be mixed according to the manufacturer's instructions (PD SWISS). After achieving a creamy mixture, MTA shall be delivered to the pulp chamber using an amalgam carrier to a 1-2mm thickness. Using a moist pellet, it will be condensed gently over the exposed pulp stumps. Once an initial set of MTA is achieved, the access cavity shall be restored with a glass ionomer cement and composite restoration.
実験的:Intervention
R. officinalis as pulpotomy medicament
A sterile cotton pellet dipped and squeezed in 6.25% aqueous extract of R-officinalis will be placed over the radicular pulp for 5 minutes. Then, the pulp chamber will be sealed with a thick paste aqueous extract of R. officinalis and zinc oxide powder. The access cavity shall be restored with glass ionomer cement and a composite restoration.

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
Pain After Intervention, Tenderness to palpation, percussion , Swelling
時間枠:Preop Post op after 1 week, 1month 3 month 6 month

The incidence and intensity of pain will be assessed postoperatively using the Visual Analogue scale.

Pain intensity will be noted as no pain (0-4mm), mild pain (5-44), moderate pain (45-74mm) and severe pain (75-100mm) on a scale of 0-100mm

Preop Post op after 1 week, 1month 3 month 6 month
Periapical status after intervention
時間枠:Preop Post op 3 month 6 month

The periapical status will be assessed by using the periapical index [PAI] scoring system. Each tooth will be assigned to one of the PAI scores for the 5 categories within the scale. PAI less than or equal to 2 would be successful outcome.

  1. Normal periapical structures
  2. Small changes in bone structures
  3. Changes in bone structure with mineral loss
  4. Periodontitis with well-defined radiolucent area
  5. Severe periodontitis with exacerbating features
Preop Post op 3 month 6 month

協力者と研究者

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研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年6月1日

一次修了 (推定)

2026年12月1日

研究の完了 (推定)

2026年12月31日

試験登録日

最初に提出

2026年4月29日

QC基準を満たした最初の提出物

2026年5月21日

最初の投稿 (実際)

2026年5月27日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月27日

QC基準を満たした最後の更新が送信されました

2026年5月21日

最終確認日

2026年5月1日

詳しくは

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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?

未定

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

いいえ

米国FDA規制機器製品の研究

いいえ

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