NCT07477171

Brief Summary

The main objective of this study is to compare the healing rate of periapical lesions after non-surgical endodontic retreatment in teeth obturated with gutta-percha versus those obturated with mineral trioxide aggregate (MTA), with a 12-month follow-up. Secondary objectives include evaluating differences between groups in healing time, postoperative pain, and tooth discoloration.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress39%
Mar 2026Apr 2027

Study Start

First participant enrolled

March 1, 2026

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 17, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

1.1 years

First QC Date

March 12, 2026

Last Update Submit

March 18, 2026

Conditions

Periapical DiseasesRoot Canal TherapyMineral Trioxide Aggregate (MTA)

Keywords

non-surgical endodontic retreatmentbioceramicgutta-percha

Outcome Measures

Primary Outcomes (1)

  • Healing of periapical lesions

    Radiographic healing of periapical lesions following non-surgical endodontic retreatment, assessed by standardized periapical radiographs and confirmed by cone beam computed tomography (CBCT) when complete healing is suspected. Two blinded evaluators will assess the radiographic outcomes.

    Follow-up visits at 3, 6, 9, and 12 months post-treatment.

Secondary Outcomes (2)

  • Tooth discoloration

    Evaluated at baseline (pre-retreatment) and at 3, 6, 9, and 12 months post-treatment.

  • Postoperative Pain

    Perioperative (between appointments), 24 hours postoperative, 48 hours postoperative, 1 week postoperative

Study Arms (2)

Mineral trioxide aggregate (MTA) group

EXPERIMENTAL

Participants in this arm will undergo non-surgical endodontic retreatment following standard clinical procedures. After removal of the previous root canal filling and chemomechanical preparation, the root canals will be obturated with mineral trioxide aggregate (MTA). Calcium hydroxide will be used as intracanal medication between visits prior to final obturation.

Device: Mineral trioxide aggregate (MTA) group

Gutta-percha group

ACTIVE COMPARATOR

Participants in this arm will undergo non-surgical endodontic retreatment following standard clinical procedures. After removal of the previous root canal filling and chemomechanical preparation, the root canals will be obturated with gutta-percha and a resin-based sealer. Calcium hydroxide will be used as intracanal medication between visits prior to final obturation.

Device: Gutta-percha group

Interventions

Mineral trioxide aggregate (MTA) groupDEVICE

Root canal obturation performed using mineral trioxide aggregate (MTA) following non-surgical endodontic retreatment. After removal of the previous root canal filling, chemomechanical preparation and irrigation of the root canal system are performed. Calcium hydroxide is used as intracanal medication between visits prior to final obturation with MTA

Mineral trioxide aggregate (MTA) group
Gutta-percha groupDEVICE

Root canal obturation performed using gutta-percha and a resin-based sealer following non-surgical endodontic retreatment. After removal of the previous root canal filling, chemomechanical preparation and irrigation of the root canal system are performed. Calcium hydroxide is used as intracanal medication between visits prior to final obturation with gutta-percha using the continuous wave technique.

Gutta-percha group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients ≥18 years old American Society of Anesthesiologists (ASA) physical status I and II Teeth requiring non-surgical endodontic retreatment Periapical lesion ≤10 mm in maximum diameter on periapical radiograph Apical canal diameter ≤ size 50 Teeth without periodontal defects or mobility

You may not qualify if:

  • Smokers Teeth with insufficient remaining tooth structure Teeth requiring surgical retreatment Primary endodontic treatment complications (fractured instrument, perforation, ledge or apical transportation)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Medicine and Dentistry

Santiago de Compostela, A Coruña, 15705, Spain

Location

MeSH Terms

Conditions

Periapical Diseases

Condition Hierarchy (Ancestors)

Jaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth Diseases

Central Study Contacts

Tania Gancedo-Gancedo

CONTACT

+ 34 608439156tania.gancedo.g@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Professor of Endodontics, University of Santiago de Compostela

Study Record Dates

First Submitted

March 12, 2026

First Posted

March 17, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

March 23, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)