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NCT Number: NCT06973135

Non-Surgical Single Visit Endodontic Retreatment in Cases With Asymptomatic Apical Periodontitis Using Bioceramic Sealer

The goal of this clinical trial is to learn if using bioceramic sealers in non surgical single visit endodontic retreatment in patients with endodontic treatment failure and asymptomatic apical periodontitis will work in comparison to other resin sealer which proved efficacy ,and help healing of the periapical lesions and reduce the anticipated postoperative pain , Participants will have root canal retreatment done in a single visit and then follow up will be done in 1, 3 and 6 months to check healing and then after 12 months , also postoperative pain will be monitored through communicating the patients after 24, 28 , 72 hours and the 7 days

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Asymptomatic Apical Periodontitis Root Canal Retreatment

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

faculty of dentistry Alexandria university

Alexandria, Alexandria Governorate, 0000, Egypt

About this study

selection of the cases will be done according to the eligibility criteria the a baseline periapical radiograph to record the periapical index and base line CBCT will be done to measure the lesion size and record the CBCTPAI then patients will be divided into two groups (A AND B) randomly to perform single visit non surgical root canal retreatment using bioceramic sealer in obturation in group A and resin sealer in group B then post operative pain assessment will be done using numerical scale after 24, 48, 72 hours and 7 days .for radiographical and clinical measuring of the healing follow up will done after 1, 3, 6 and 12 months by performing periapical radiographs and recording PAI and clinical signs or symptoms and CBCT after 12 months to record CBCTPAI and compare the size differences at baseline

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Mandibular molar teeth with previous unsuccessful endodontic treatment from ≥ 1 year with asymptomatic apical periodontitis.
  • Teeth with inadequate obturation.
  • Teeth with broken instruments that can be bypassed and/or retrieved and not present in the apical third or passing through the apex.
  • Teeth with periapical lesion.
  • Patient with the ages of 18-65 years.
  • Patient medically healthy and free from systemic diseases or with mild controlled systemic disease. ASA I, II * (52).
  • Patient with no acute pain or extraoral swelling.
  • Patients who agreed to participate in the study and attend the control visits.

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Exclusion criteria

  • Teeth requiring retreatment with a poor prognosis (root canal morphology altered, large carious cavity, internal or external root resorption, root perforation)
  • Teeth with vertical root fracture or open apex.
  • Patient with systemic disorders related to bone metabolism and using drugs that may affect bone metabolism.
  • Pregnant patients.
  • Patient under antibiotics treatment 2 weeks before the treatment.
  • Patients who could not attend follow up will be excluded from the study

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Treatment and study plan

Bioceramic sealer root canal obturation

Procedure

Mandibular molars root canal obturation with bioceramic sealer after non surgical endodontic retreatment and then immediate periapical radiograph will be done to record PAI

resin sealer root canal obturation

Procedure

non surgical root canal retreatment of mandibular molar teeth will be done using resin based sealer in obturation and periapical radiograph will be taken immediately to record PAI

Primary outcomes

  1. Measure the healing of periapical lesions through comparing size of lesion using periapical radiograph and CBCT before and after 1 year follow up

    Time frame: 21 months

    periapical radiograph and cone beam computed tomography will be taken to measure the size of the lesion and record the PAI and CBCTPAI at baseline then root canal retreatment will be done in single visit using bioceramic sealer in obturation in group A and resin sealer in group B and then periapical radiograph will be taken after 1, 3, 6 , 12 months to record PAI and CBCT at 12 months to record CBCTPAI to evaluate healing through measuring the sizes of periapical lesions , together with clinical record of the patients symptoms after 1, 3 ,6 and 12 months

Secondary outcomes

  1. Clinical assessment of post operative pain

    Time frame: 21 months

    The postoperative pain will be recorded using a numeric rating scale (NRS) on a 0-10 scale, with 0 indicating no pain and 10 indicating the worst pain. Patients were required to report their pain level at 4-time intervals after obturation: 24, 48, 72 hours and 7 days. The highest pain score recorded at 3 consecutive time points will be selected

Sponsors and collaborators

Lead sponsor

Saly Nazeer

Other

Registry information

Official study title

Outcome Of Non-Surgical Single Visit Endodontic Retreatment in Teeth With Asymptomatic Apical Periodontitis Using Bioceramic Sealer (A Randomized Controlled Clinical Trial)

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 15, 2025
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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