Evaluation of Guided Endodontic Microsurgery and Two Different Retrograde Filling Materials

NCT07184151 | Completed DMC

• 1 other identifier: (REC) (379/ 2021)
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to evaluate the effect of guided endodontic microsurgical root end resection on bone healing compared to nonguided microsurgery using two different retrograde filling material (Well root putty, MTA) by cone-beam computed tomography.

Conditions

Endodontic Re-treatment Failure

Keywords

MTA; Well root putty; guided endodontic

Outcome Measures

Primary Outcomes (1)

• Operating time

  The operating time was measured from the beginning of osteotomy to the end of retrograde filling procedure

  perioperative

Secondary Outcomes (5)

• Change in bone density measurement over time

  1 week, 6 months

• Pain "Numerical Rating Scale (NRS)"

  first day , 1 week

• Change in Linear measurements over time

  baseline and 6 months

• Bone healing assessment

  baseline and at 6 months

• Change in volumetric measurement over time

  1 week, 6 months

Study Arms (4)

microsurgical apicoectomy without guide+MTA

ACTIVE COMPARATOR

Drug: MTA retrograde filling

microsurgical apicoectomy without guide+well root putty ( premixed bioceramic putty) retrograde fil

EXPERIMENTAL

Drug: well root putty ( premixed bioceramic putty) retrograde filling

microsurgical apicoectomy with guide+MTA

EXPERIMENTAL

Drug: MTA retrograde filling

microsurgical apicoectomy with guide+well root putty ( premixed bioceramic putty) retrograde fil

EXPERIMENTAL

Drug: well root putty ( premixed bioceramic putty) retrograde filling

Interventions

well root putty ( premixed bioceramic putty) retrograde filling DRUG

well root putty ( premixed bioceramic putty) retrograde filling

microsurgical apicoectomy with guide+well root putty ( premixed bioceramic putty) retrograde fil; microsurgical apicoectomy without guide+well root putty ( premixed bioceramic putty) retrograde fil

MTA retrograde filling DRUG

MTA retrograde filling

microsurgical apicoectomy with guide+MTA; microsurgical apicoectomy without guide+MTA

Eligibility Criteria

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

You may qualify if:

• Tooth is restorable pocket depth is less than 4mm and mobility in its normal limit ( less than 1mm)
• Persisting or emerging disease following root-canal treatment when root canal re-treatment is inappropriate.
• Tooth with acceptable endodontic treatment and have a new post and crown restoration, but have a persistent or enlarging periapical lesion ( size less than 10 mm)
• Obstructed canal (the obstruction proved not to be removable, by passed and the risk of damage was too great).
• Extruded material or instrument with clinical or radiological findings of apical periodontitis and/or symptoms are present.

You may not qualify if:

• Non restorable tooth
• Contraindicating medical condition ( severe systemic condition and psychological condition)
• Anatomical contra indication
• Poor general oral status and supporting periodontal tissue.

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Faculty of Dentistry, Suez Canal University

Ismailia, Egypt

Location

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: PRINCIPAL INVESTIGATOR
• PI Title: PHD Candidate at the Faculty of Dentistry, Suez Canal University

Study Record Dates

• First Submitted: September 13, 2025
• First Posted: September 19, 2025
• Study Start: January 20, 2022
• Primary Completion: August 12, 2023
• Study Completion: April 15, 2024
• Last Updated: October 1, 2025

Record last verified: 2025-09

Locations

EG (1)