Clinical trial NCT06973135: Non-Surgical Single Visit Endodontic Retreatment in Cases With Asymptomatic Apical Periodontitis Using Bioceramic Sealer
Official title: Outcome Of Non-Surgical Single Visit Endodontic Retreatment in Teeth With Asymptomatic Apical Periodontitis Using Bioceramic Sealer (A Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Asymptomatic Apical Periodontitis
Root Canal Retreatment
Keywords: CBCT
secondary root canal treatment
asymptomatic apical periodontitis
bioceramic sealer
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2025-05-15
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

   -

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

   -

Primary outcomes:
measure: Measure the healing of periapical lesions through comparing size of lesion using periapical radiograph and CBCT before and after 1 year follow up
timeFrame: 21 months
Secondary outcomes:
measure: Clinical assessment of post operative pain
timeFrame: 21 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: faculty of dentistry Alexandria university
city: Alexandria
country: Egypt
facility: faculty of dentistry Alexandria university
Study officials:
affiliation: Alexandria University
name: Sybel M Moussa, Phd
role: STUDY_DIRECTOR
affiliation: Alexandria University
name: Nehal Lehita, Phd
role: STUDY_DIRECTOR
References: