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Search / Trial NCT05714384

Outcome of Calcium Silicate Sealer-based Obturation in Root Canal Retreatment

Launched by MINISTRY OF HEALTH, KUWAIT · Jan 26, 2023

Trial Information

Current as of September 12, 2025

Enrolling by invitation

Keywords

ClinConnect Summary

This study is checking how well a calcium silicate–based root canal sealer (CeraSeal) works when used in retreating teeth that still have infection near the root tip. Endodontists will perform retreatments using this sealer, and researchers will follow patients for 12 months to see how well the area heals. Healing will be assessed with 3D dental scans (CBCT) and by looking at whether patients have pain, swelling, or other signs of infection. The main questions are the rate of radiographic healing, and the overall clinical outcome (whether symptoms disappear or persist) at 12 months, with an analysis to identify factors that may predict success or failure. About 126 teeth are planned to be evaluated.

Who can participate? Adults aged 21 to 65 who need root canal retreatment for persistent periapical disease and are otherwise in good health (ASA I–II) may be eligible, provided they can give informed consent, have good oral hygiene, and have restorable teeth with fully formed roots. Exclusion criteria include higher health risk (ASA III or more), pregnancy, inability to consent, advanced gum disease, teeth with poor prognosis or certain complications (e.g., blocked canals, vertical fractures, extrusion of sealer). The study takes place at Jaber Al-Ahmed Dental Center in Kuwait and involves follow-up visits for at least 12 months; data are kept anonymous and not shared with other researchers. The project is led by Kuwait’s Ministry of Health with a specialist in endodontics as the investigator.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Participants must be 21-65 years of age at the time of recruitment
  • Participants must have a classification of I or II on the American Society of Anesthesiologists (ASA) physical status classification system
  • Participants must not have known allergies to any materials used in the study
  • Participants must agree to participate in the study by signing a consent form
  • Participants must have good oral hygiene
  • All types of permanent teeth that require root canal retreatment are included (incisors, canines, premolars \& molars)
  • The teeth must be restorable and have fully formed roots with no advanced periodontal disease
  • Exclusion Criteria:
  • ASA classification of III or more
  • Pregnant or breastfeeding women
  • Patients who are unable to give consent
  • Patients who have advanced periodontal disease or teeth with more than 4mm probing
  • Teeth with incomplete root formation
  • Teeth that have a poor restorative prognosis
  • Teeth presenting with signs of a vertical root fracture
  • Teeth with blocked or non-negotiable canals
  • Teeth with broken instruments
  • Teeth with iatrogenic perforations
  • Teeth requiring posts or extensive prosthetic rehabilitation
  • Teeth with cracks
  • Teeth with internal or external root resorption
  • Teeth with uncontrollable exudate

About Ministry Of Health, Kuwait

The Ministry of Health in Kuwait serves as a pivotal clinical trial sponsor dedicated to advancing healthcare through rigorous research and innovation. Committed to enhancing public health outcomes, the Ministry oversees a range of clinical studies aimed at evaluating new treatments, medical devices, and healthcare strategies. By fostering collaboration among healthcare professionals, researchers, and regulatory bodies, the Ministry ensures adherence to ethical standards and regulatory compliance while promoting evidence-based practices. Its initiatives reflect a strategic focus on improving patient care and addressing the evolving health needs of the Kuwaiti population.

Locations

Kuwait, Hawalli Governate, Kuwait

Janūb As Surrah, Hawalli Governate, Kuwait

Janūb As Surrah, Hawalli Governate, Kuwait

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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