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Not yet recruiting NCT07477171

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

No phase Interventional Periapical Diseases Root Canal Therapy Mineral Trioxide Aggregate (MTA)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mineral trioxide aggregate (MTA) group, Gutta-percha group.
Who it may be relevant to
Registry conditions: Periapical Diseases, Root Canal Therapy, Mineral Trioxide Aggregate (MTA). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

  • 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
  • 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.

Primary outcome measures

  • Healing of periapical lesions [Time frame: Follow-up visits at 3, 6, 9, and 12 months post-treatment.]
Secondary outcome measures (2)
  • Tooth discoloration [Time frame: 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]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Spain · 1 center
  • School of Medicine and Dentistry — Santiago de Compostela

Identifiers

NCT: NCT07477171 · USC-019/2026-H

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗