Mineral Trioxide Aggregate (MTA) vs Gutta-Percha for Non-Surgical Endodontic Retreatment in Teeth With Apical Lesions

March 18, 2026 updated by: Tania Gancedo-Gancedo, University of Santiago de Compostela

Comparison of Two Root Canal Filling Materials in Non-Surgical Endodontic Retreatment: A Randomized Controlled Clinical Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Visit 1: Eligible adult patients requiring non-surgical endodontic retreatment and presenting with apical periodontitis will be recruited. After providing written informed consent, participants will undergo clinical and radiographic screening to confirm eligibility criteria. Baseline assessment will include clinical examination, periapical radiography using a standardized parallel technique, and cone beam computed tomography (CBCT) imaging to evaluate the cause of failure of the previous root canal treatment and to measure the size of the periapical lesion. In addition, tooth color will be measured before treatment using a spectrophotometer in order to establish baseline values for the evaluation of possible discoloration during follow-up. Participants will then be randomly assigned to one of two treatment groups according to the obturation material used during retreatment: gutta-percha with resin-based sealer or mineral trioxide aggregate (MTA). Randomization will be performed using block randomization to ensure balanced group allocation. Visit 2: Non-surgical endodontic retreatment will be performed under rubber dam isolation and dental operating microscope by experienced endodontists. The previous root canal filling material will be removed using ultrasonic tips, manual instruments, and nickel-titanium rotary instruments. Working length will be determined using an electronic apex locator and confirmed radiographically. The canals will be irrigated with sodium hypochlorite and prepared using standard chemomechanical techniques. Calcium hydroxide will be placed as intracanal medication for a minimum of three weeks, and a temporary restoration will be placed Visit 3: The temporary restoration and intracanal medication will be removed and final irrigation will be performed. Root canals will then be obturated either with gutta-percha using the continuous wave technique or with mineral trioxide aggregate (MTA), according to the allocated study group. The treated tooth will then receive a definitive restoration. Patients will complete a questionnaire to record postoperative pain following the treatment. Visit 4, 5, 6 and 7: Follow-up visits will be scheduled every three months for up to 12 months or until further intervention is required. At each follow-up visit, clinical examination and standardized periapical radiographs will be performed to evaluate periapical healing. Tooth color will also be reassessed during follow-up. When complete healing is suspected radiographically, CBCT imaging will be performed to confirm three-dimensional healing.

Study Type

Interventional

Enrollment (Estimated)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • A Coruña
      • Santiago de Compostela, A Coruña, Spain, 15705
        • School of Medicine and Dentistry
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Gutta-percha group
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
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.
Experimental: Mineral trioxide aggregate (MTA) group
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healing of periapical lesions
Time Frame: Follow-up visits at 3, 6, 9, and 12 months post-treatment.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tooth discoloration
Time Frame: Evaluated at baseline (pre-retreatment) and at 3, 6, 9, and 12 months post-treatment.
Presence or absence of tooth discoloration, measured using a spectrophotometer before the retreatment and at each follow-up visit.
Evaluated at baseline (pre-retreatment) and at 3, 6, 9, and 12 months post-treatment.
Postoperative Pain
Time Frame: Perioperative (between appointments), 24 hours postoperative, 48 hours postoperative, 1 week postoperative
Assessment of patient-reported postoperative pain using a standardized questionnaire.
Perioperative (between appointments), 24 hours postoperative, 48 hours postoperative, 1 week postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Santiago de Compostela

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

March 12, 2026

First Submitted That Met QC Criteria

March 12, 2026

First Posted (Actual)

March 17, 2026

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USC-019/2026-H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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