Mineral Trioxide Aggregate (MTA), Periapical Diseases, Root Canal Therapy
Conditions
Keywords
non-surgical endodontic retreatment, bioceramic, gutta-percha
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.
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
DEVICEMineral 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
DEVICEGutta-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.
Sponsors
University of Santiago de Compostela
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Healing of periapical lesions | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tooth discoloration | 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. |
| Postoperative Pain | Perioperative (between appointments), 24 hours postoperative, 48 hours postoperative, 1 week postoperative | Assessment of patient-reported postoperative pain using a standardized questionnaire. |
Countries
Spain
Contacts
CONTACTTania Gancedo-Gancedo
Outcome results
None listed