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

NCT ID: NCT06973135

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2026-12-31

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

Detailed Description

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

Conditions

Asymptomatic Apical Periodontitis; Root Canal Retreatment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

bioceramic sealer group

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

Group Type: ACTIVE_COMPARATOR

Bioceramic sealer root canal obturation

Intervention Type: 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 group

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

Group Type: ACTIVE_COMPARATOR

resin sealer root canal obturation

Intervention Type: 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

Interventions

Bioceramic sealer root canal obturation

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

Intervention Type: PROCEDURE

resin sealer root canal obturation

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Mandibular molar teeth with previous unsuccessful endodontic treatment from ≥ 1 year with asymptomatic apical periodontitis.

2. Teeth with inadequate obturation.

3. Teeth with broken instruments that can be bypassed and/or retrieved and not present in the apical third or passing through the apex.

4. Teeth with periapical lesion.

5. Patient with the ages of 18-65 years.

6. Patient medically healthy and free from systemic diseases or with mild controlled systemic disease. ASA I, II * (52).

7. Patient with no acute pain or extraoral swelling.

8. Patients who agreed to participate in the study and attend the control visits.

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Exclusion Criteria

1. Teeth requiring retreatment with a poor prognosis (root canal morphology altered, large carious cavity, internal or external root resorption, root perforation)

2. Teeth with vertical root fracture or open apex.

3. Patient with systemic disorders related to bone metabolism and using drugs that may affect bone metabolism.

4. Pregnant patients.

5. Patient under antibiotics treatment 2 weeks before the treatment.

6. Patients who could not attend follow up will be excluded from the study

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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Saly Nazeer

OTHER

Sponsor Role: lead

Responsible Party

Saly Nazeer

doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sybel M Moussa, Phd

Role: STUDY_DIRECTOR

Alexandria University

Nehal Lehita, Phd

Role: STUDY_DIRECTOR

Alexandria University

Locations

faculty of dentistry Alexandria university

Alexandria, , Egypt

Site Status: RECRUITING

faculty of dentistry Alexandria university

Alexandria, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

sally M Nazir, Master

Role: CONTACT

sallymohamed87@gmail.com

+201002040144

Facility Contacts

Sally M nazir, master

Role: primary

sallymohamed87@gmail.com

01002040144

Sally M Nazir, master degree

Role: primary

sallymohamed87@gmail.com

+201002040144

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Study Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

0966-09/2024

Identifier Type: -

Identifier Source: org_study_id