An interventional study of Mineral trioxide aggregate (MTA) group and Gutta-percha group in Periapical Diseases, Root Canal Therapy and Mineral Trioxide Aggregate (MTA), sponsored by University of Santiago de Compostela. Not yet recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-23.
Sponsored by University of Santiago de Compostela · Not applicable, Interventional, and Treatment
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.
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.
44 studies on the registry are indexed under Periapical Diseases; 12 are open to participants now.
This study's planned enrollment of 58 is close to the median of 60 across 35 interventional studies indexed under Periapical Diseases.
Browse Periapical Diseases studies →University of Santiago de Compostela is the lead sponsor of 59 studies on the registry; 11 are open to participants now.
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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)
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
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 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
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.
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.
Time frame: Follow-up visits at 3, 6, 9, and 12 months post-treatment.
Tooth discoloration
Presence or absence of tooth discoloration, measured using a spectrophotometer before the retreatment and at each follow-up visit.
Time frame: Evaluated at baseline (pre-retreatment) and at 3, 6, 9, and 12 months post-treatment.
Postoperative Pain
Assessment of patient-reported postoperative pain using a standardized questionnaire.
Time frame: Perioperative (between appointments), 24 hours postoperative, 48 hours postoperative, 1 week postoperative
Plan to share: No
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University of Santiago de Compostela