The Effect of XP-Endo Finisher Activation of Bioceramic Sealer on Postoperative Pain in Mandibular First Molar With Symptomatic Irreversible Pulpitis

NCT06640231 | Recruiting

• 1 other identifier: FUE.REC(21)/7-2024
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of endodontic obturation is to make a complete sealing along the length of the root canal system to ensuring the peri radicular tissue healing and sustained health. Disadvantages of gutta-percha-based root filling materials is lack of adhesiveness to canal wall dentin. So, a sealer or cement has to be used with gutta-percha to achieve a fluid-tight seal and fill the space between the canal wall dentin and the obturating material. Drawbacks of resin-based sealer are difficult preparation technique of deep root canal cavity which also limit dentin bonding, difficult to be removed from the canal in retreatment cases and its shrinkage during setting. Bio-ceramic root canal sealers become popular in recent years because of their unique chemical and physical properties. These sealers are consisting of biocompatible materials that resemble the of tooth structure natural composition so bio-ceramic sealers are an ideal choice for root canal treatment. Bio-ceramic sealers are better than traditional sealers due to their multiple physical properties for example excellent sealing ability, dimensional stability, and low solubility. These properties ensure that the sealers achieve a tight seal, inhibiting bacterial leakage and decreasing the risk of reinfection. Diaroot Bioaggregate (DiaDent), a white nanoparticle-sized ceramic cement composed of calcium silicate, calcium hydroxide and hydroxyapatite and considered a modified version of MTA, with the advantage of being aluminium-free in composition, a fact that contributes to its greater biocompatibility with periradicular tissue.Root canal sealers activation may improve their penetration into dentinal tubules and improve sealability and antimicrobial effects. Recently, a non-tapered nickel-titanium rotary instrument (XP-endo Finisher; FKG, La Chaux-de-Fonds, Switzerland) has been designed to increase the efficiency in root canal wall cleaning specifically with limited impact on dentine throughout the literature, XP efficacy in decreasing microorganisms, dissolving organic tissue from artificial cavities in combination with NaOCl and penetrating into the isthmus has been analyzed. The aim of this study to evaluate the effect of XP-Endo Finisher activation of Bioceramic sealer on postoperative pain in mandibular first molar with symptomatic irreversible pulpitis. This study consists of 30 patients divided into 2 group each group having 15 patients. Intervention: Bioceramic sealer activation with XP Endo Finisher. Control group: Bioceramic sealer without activation.

Conditions

Symptomatic Irreversible Pulpitis

Keywords

Postoperative pain

Outcome Measures

Primary Outcomes (1)

• Post-operative pain after sealer activation with XP-Endo Finisher in comparison to without sealer activation

  Measuring of post-operative pain by Numerical rate scale(NRS) and pain level will be assigned to one of 4 categorical scores: None (0); Mild (1-3); Moderate (4-6); Severe (7-10).

  Immediately after obturation, 6-, 12-, 24- and 48-hours post-operative.

Secondary Outcomes (1)

• Number of analgesic tablets taken after endodontic treatment with sealer activation in comparison to without sealer activation

  Up to 48 hours postoperatively.

Other Outcomes (1)

• Lateral or periapical extrusion of sealer.

  Immediately after obturation.

Study Arms (2)

Bioceramic sealer activation with XP Endo Finisher.

ACTIVE COMPARATOR

Other: sealer activation after cleaning and shaping with XP-Endo Finisher

Bioceramic sealer without activation.

ACTIVE COMPARATOR

Other: negative control where canals are obturated directly without sealer activation

Interventions

sealer activation after cleaning and shaping with XP-Endo Finisher OTHER

activation of sealer before the obturation of root canals

Bioceramic sealer activation with XP Endo Finisher.

negative control where canals are obturated directly without sealer activation OTHER

sealer after cleaning and shaping before the obturation without using activation method

Bioceramic sealer without activation.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age ranges from 18 to 40 years old.
• No sex predilection.
• Patients seeking root canal treatment.
• Systematically healthy patient (ASA I, II).
• Patient who can understand numerical rate scale and sign an informed consent.
• Mandibular first molar teeth with:
• Preoperative sharp (moderate or severe) pain.
• Vital response of pulp tissue to cold pulp tester (ethyl chloride spray).
• Normal periapical radiographic appearance.

You may not qualify if:

• Patients with American association of anesthesiologists (ASA) classification other than ASA T\& II.
• Patients who have already ingested preoperative medication, such as analgesics, non-steroidal or steroidal anti-inflammatory drugs, within 12 hours of the start of treatment.
• Patients with NSAIDs allergy.
• Patients having two or more adjacent teeth needing root canal therapy.
• Pregnant patients.
• Patients with bleeding disorder.
• Patients with long term corticosteroid use
• Teeth having;
• Necrotic pulp.
• History or presence of swelling or fistulous tract.
• Acute / chronic periapical abscess.
• Mobility more than grade 1.
• Pocket depth more than 5mm.
• No possible restorability.
• Previous root canal treatment.

Sponsors & Collaborators

• Future University in Egypt: lead

Study Sites (1)

Future University in Egypt

Cairo, New Cairo, 11835, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 15, 2024
• Study Start: November 1, 2024
• Primary Completion: November 1, 2025
• Study Completion: April 1, 2026
• Last Updated: June 29, 2025

Record last verified: 2024-10

Locations

EG (1)