Periapical DiseasesNCT07477171
Mineral Trioxide Aggregate (MTA) vs Gutta-Percha for Non-Surgical Endodontic Retreatment in Teeth With Apical Lesions
A study testing Mineral trioxide aggregate (MTA) group and Gutta-percha group in people with Periapical Diseases and Root Canal Therapy, run by University of Santiago de Compostela at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periapical Diseases, Root Canal Therapy, Mineral Trioxide Aggregate (MTA)
- What is being tested?
- Mineral trioxide aggregate (MTA) group and Gutta-percha group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2026to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Smokers Teeth with insufficient remaining tooth structure Teeth requiring surgical retreatment Primary endodontic treatment complications (fractured instrument, perforation, ledge or apical transportation)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
School of Medicine and Dentistry
Santiago de Compostela, A Coruña, 15705
Tania Gancedo-Gancedo, + 34 608439156, tania.gancedo.g@gmail.com
About this study
Official title: 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.
Read the 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.
- Being tested
- Mineral trioxide aggregate (MTA) group, Gutta-percha group
- Keywords
- non-surgical endodontic retreatment, bioceramic, gutta-percha
- Medical subject headings
- Periapical Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Gutta-percha group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Follow-up visits at 3, 6, 9, and 12 months post-treatment.
Secondary outcomes (2)
Tooth discoloration
Presence or absence of tooth discoloration, measured using a spectrophotometer before the retreatment and at each follow-up visit.
Measured: 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.
Measured: Perioperative (between appointments), 24 hours postoperative, 48 hours postoperative, 1 week postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study startMar 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periapical DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Santiago de Compostela
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tania Gancedo-Gancedo, University of Santiago de Compostela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07477171
- Sponsor's protocol ID
- USC-019/2026-H
- Status last verified
- Mar 2026
- First submitted
- 12 Mar 2026
- Last updated
- 23 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Root Canal Filling Materials in Non-Surgical Endodontic Retreatment: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07477171
- Acronym / sponsor ID
- USC-019/2026-H
- Keywords
- non-surgical endodontic retreatment, bioceramic, gutta-percha
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- University of Santiago de CompostelaUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mineral trioxide aggregate (MTA) group | Experimental | Device: Mineral trioxide aggregate (MTA) groupParticipants 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. |
| Gutta-percha group | Active comparator | Device: Gutta-percha groupParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Smokers Teeth with insufficient remaining tooth structure Teeth requiring surgical retreatment Primary endodontic treatment complications (fractured instrument, perforation, ledge or apical transportation)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mineral trioxide aggregate (MTA) groupRoot 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 | Mineral trioxide aggregate (MTA) group |
| Gutta-percha groupRoot 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. | Device | Gutta-percha group |
Primary outcome
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mineral trioxide aggregate (MTA) group and Gutta-percha group in people with Periapical Diseases and Root Canal Therapy, run by University of Santiago de Compostela at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tania Gancedo-Gancedo (+ 34 608439156, tania.gancedo.g@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing of periapical lesions (time frame: Follow-up visits at 3, 6, 9, and 12 months post-treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.