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Influence of Sealer Composition on Post-Endodontic Pain

2026年8月11日 更新者:Nourhan Rabie Ahmed、Minia University

Influence of Sealer Composition on Post-Endodontic Pain: A Prospective Comparative Analysis of Three Root Canal Sealers

Postoperative pain (PP) is one of the most common and clinically significant complications following endodontic therapy, occurring shortly after treatment and potentially lasting from a few hours to several days, thereby compromising the patient's quality of life.

The incidence of PP varies widely in the literature, ranging from 1.7% to 70%, with some studies reporting values up to 80% within the first 24 hours, gradually decreasing over a week.

調査の概要

詳細な説明

Postoperative pain (PP) is one of the most common and clinically significant complications following endodontic therapy, occurring shortly after treatment and potentially lasting from a few hours to several days, thereby compromising the patient's quality of life .

The incidence of PP varies widely in the literature, ranging from 1.7% to 70%, with some studies reporting values up to 80% within the first 24 hours, gradually decreasing over a week . The pathophysiology of postoperative pain involves mechanical, chemical, or microbial injury to the periapical tissues, which triggers an acute inflammatory response characterized by the release of inflammatory mediators, vasodilation, increased vascular permeability, and leukocyte migration, ultimately activating sensory neurons and generating pain.

The etiology of PP is multifactorial, including patient-related factors such as age, gender, tooth type particularly mandibular molars preoperative pain, and periapical radiolucency, as well as treatment-related factors such as instrumentation protocol, irrigation solution, working length determination, occlusal adjustment, number of visits, anesthesia type, and prophylactic analgesics. Understanding these variables allows clinicians to select techniques and materials that minimize postoperative discomfort.

Root canal obturation plays a critical role in postoperative pain, as sealers may come into direct contact with periradicular tissues or extrude through the apical foramen, eliciting cytotoxic and inflammatory responses . The chemical composition and biocompatibility of the sealer influence tissue reaction, periapical healing, and subsequent pain perception.

Traditionally, epoxy resin-based sealers, such as AH Plus®, have been considered the gold standard due to their excellent sealing properties, radiopacity, dimensional stability, and clinical performance; however, extrusion of these sealers has been associated with cytotoxicity and inflammation.

Calcium hydroxide-based sealers have long been used in endodontics, providing antibacterial effects, low cytotoxicity, and osteogenic and cementogenic potential, contributing to periapical repair.

More recently, calcium silicate-based bioceramic sealers, including tricalcium silicate formulations like BioRoot and EndoSeal MTA, have gained popularity due to their bioactivity, biocompatibility, ability to set in humid conditions, alkaline pH, calcium ion release, antimicrobial properties, and promotion of tissue regeneration with lower inflammatory mediator production.

These properties suggest that bioceramic sealers may reduce postoperative pain compared to traditional sealers, while supporting enhanced periapical healing and osteogenic induction.

Despite studies evaluating postoperative pain with different sealers, results remain controversial, and there is limited evidence specifically comparing the effects of epoxy resin-based versus calcium silicate-based sealers on pain outcomes following single-visit endodontic treatment.

This highlights a need for further randomized clinical trials to assess the incidence and severity of postoperative pain associated with these materials, particularly in patients with varying pulpal and periapical conditions.

研究の種類

介入

入学 (推定)

66

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

研究連絡先のバックアップ

研究場所

      • Minya、エジプト
        • 募集
        • Endodontics Department Faculty of Dentistry
        • コンタクト:

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:

  • Patients requiring primary root canal treatment.
  • Patients with acute irreversible pulpitis.
  • Patients in good general health

Exclusion Criteria:

  • Patients with systemic diseases affecting pain perception or healing.
  • Patients who had taken analgesics or antibiotics within 12-24 hours prior to treatment.
  • Pregnant or lactating women.
  • Previously treated teeth or teeth with root resorption, fractures, or severe periodontal disease

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: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
アクティブコンパレータ:Group A (Calcium Hydroxide-based Sealer: Sealapex):

About 22 cases will be subjected to:

  1. Canals will be dried using sterile paper points, avoiding excessive desiccation to maintain optimal canal conditions prior to sealer placement.
  2. The sealer will be dispensed according to the manufacturer's instructions. Gutta-percha master cones will be lightly coated with the sealer and inserted to the full working length. Additional sealer may be applied into the canal using a lentulo spiral or an appropriate intracanal delivery tip when indicated.
  3. Accessory gutta-percha cones will be inserted into each canal to fill the spaces created by the spreader using a lateral compaction technique.
  4. After achieving optimal obturation of the canal, excess gutta-percha will be seared off at the canal orifices using a heated instrument.
  5. Excess sealer will be removed from the pulp chamber using a sterile cotton pellet moistened with saline.
to evaluate and compare the incidence and intensity of postoperative pain following single-visit root canal treatment using three different root canal sealers-calcium hydroxide-based, calcium silicate-based (bioceramic), and epoxy resin-based sealers-in patients with single-rooted teeth, in order to determine the effect of sealer type on patient comfort and analgesic consumption.
他の名前:
  • Bioceramic Sealer and Resin-based Sealer
アクティブコンパレータ:Group B (Bioceramic Sealer: Well-Root):

About 22 cases will be subjected to:

  1. Canals will be dried using sterile paper points, avoiding over drying to maintain slight moisture within the dentinal tubules, which is favorable for the setting reaction of the bioceramic sealer.
  2. The premixed bioceramic sealer will be dispensed directly into the canal using the manufacturer's intracanal delivery tip adjusted to 1-2 mm short of the working length, or applied onto the master gutta-percha cone prior to insertion.
  3. The master gutta-percha cone will be inserted to the full working length. Accessory cones will be placed when necessary using a lateral compaction technique to ensure complete canal obturation.
  4. After achieving optimal filling, excess gutta-percha will be seared off at the canal orifices using a heat carrier.
  5. Excess sealer will be removed from the pulp chamber using a sterile cotton pellet lightly moistened with saline.
to evaluate and compare the incidence and intensity of postoperative pain following single-visit root canal treatment using three different root canal sealers-calcium hydroxide-based, calcium silicate-based (bioceramic), and epoxy resin-based sealers-in patients with single-rooted teeth, in order to determine the effect of sealer type on patient comfort and analgesic consumption.
他の名前:
  • Bioceramic Sealer and Resin-based Sealer
アクティブコンパレータ:Group C (Resin-based Sealer: ADSEAL):

About 22 cases will be subjected to:

  1. Canals will be dried thoroughly using sterile paper points to ensure a moisture-free environment suitable for resin-based sealer application.
  2. The resin-based sealer will be mixed according to the manufacturer's instructions and applied into the canal using a lentulo spiral or coated onto the master gutta-percha cone before insertion to the working length.
  3. Accessory gutta-percha cones will be inserted using a lateral compaction technique to achieve dense canal obturation.
  4. Excess gutta-percha will be removed at the canal orifices using a heated instrument after completion of obturation.
  5. The pulp chamber will be cleaned from excess sealer using a sterile cotton pellet moistened with alcohol or saline as recommended by the manufacturer.
to evaluate and compare the incidence and intensity of postoperative pain following single-visit root canal treatment using three different root canal sealers-calcium hydroxide-based, calcium silicate-based (bioceramic), and epoxy resin-based sealers-in patients with single-rooted teeth, in order to determine the effect of sealer type on patient comfort and analgesic consumption.
他の名前:
  • Bioceramic Sealer and Resin-based Sealer

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
Post Endodontic Pain Intensity
時間枠:7 days
Postoperative pain will be assessed using a 10-cm Visual Analog Scale (VAS), where 0 will indicate "no pain" and 10 will indicate "worst imaginable pain." Participants will be instructed to record their pain intensity at 6, 12, 24, 48, and 72 hours, and on the 7th day after treatment. All recorded pain scores will be collected for statistical analysis and comparison among the study groups
7 days

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • スタディチェア:Dalia Ali Ahmed Moukarab, Professor、Professor and Head of the Endodontics Department, Faculty of Dentistry

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 (実際)

2026年4月14日

一次修了 (推定)

2027年4月1日

研究の完了 (推定)

2027年4月14日

試験登録日

最初に提出

2026年8月11日

QC基準を満たした最初の提出物

2026年8月11日

最初の投稿 (実際)

2026年8月17日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月17日

QC基準を満たした最後の更新が送信されました

2026年8月11日

最終確認日

2026年4月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • Post-Endodontic Pain

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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