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

NCT06973135 | Recruiting

• 1 other identifier: 0966-09/2024
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Asymptomatic Apical Periodontitis; Root Canal Retreatment

Keywords

CBCT; secondary root canal treatment; asymptomatic apical periodontitis; bioceramic sealer

Outcome Measures

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

  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

  21 months

Secondary Outcomes (1)

• Clinical assessment of post operative pain

  21 months

Study Arms (2)

bioceramic sealer group

ACTIVE COMPARATOR

obturation of mandibular molar root canals using bioceramic sealer after canal shaping and cleaning in single visit

Procedure: Bioceramic sealer root canal obturation

resin sealer group

ACTIVE COMPARATOR

mandibular molar root canal obturation using resin sealer after canal cleaning and shaping in single visit

Procedure: resin sealer root canal obturation

Interventions

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

bioceramic sealer group

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

resin sealer group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Saly Nazeer: lead

Study Sites (2)

faculty of dentistry Alexandria university

Alexandria, 0000, Egypt

RECRUITING

faculty of dentistry Alexandria university

Alexandria, 0000, Egypt

RECRUITING

Study Officials

• Sybel M Moussa, Phd

  Alexandria University

  STUDY DIRECTOR

• Nehal Lehita, Phd

  Alexandria University

  STUDY DIRECTOR

Central Study Contacts

sally M Nazir, Master

CONTACT

+201002040144; sallymohamed87@gmail.com

Study Design

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

Study Record Dates

• First Submitted: May 4, 2025
• First Posted: May 15, 2025
• Study Start: October 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: from January 2025 with no end date
• Access Criteria: study protocol and other data relative to the study is available at Alexandria university faculty of dentistry official site , can be accessed by anyone who would ask for

Locations

EG (2)