Endodontic InfectionRCTNCT07354373
Single-Visit and Two-Visit Endodontic Treatments
A study testing Calcium Hydroxide (CH) in people with Endodontic Infection and Periapical Periodontitis, run by University of California, San Francisco at 1 site in United States.
Trial summary
You are being asked to participate in this research study because you are being treated at the UCSF Graduate Endodontics department for an endodontic procedure. We are trying to determine the treatment outcomes of one v. two-visit endodontic treatments. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Endodontic Infection, Periapical Periodontitis
- What is being tested?
- Calcium Hydroxide (CH)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Classified as American Society of Anesthesiologists (ASA) Class I or II
- presenting with radiographic evidence of apical periodontitis-defined as a Cone-Beam Computed Tomography Periapical Index (CBCTPAI) score of 3 or greater according to the Estrela classification
Who cannot join
- Exclusion criteria included patients with uncontrolled chronic systemic conditions (e.g., diabetes, hypertension, chronic obstructive pulmonary disease), cardiovascular disease, renal or hepatic impairment, and autoimmune disorders
- History of smoking
- Periodontal disease with probing depths ≥ 3 mm.
- Root fractures
- Immature apices
- Resorption
Show all 9Show fewer
- perforations
- Inability to achieve rubber dam isolation
- Lack of informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco School of dentistry
San Francisco, California, 94143
About this study
Official title: The Efficacy of Single-Visit and Two-Visit Endodontic Treatments for Necrotic Teeth With Apical Periodontitis
You are being asked to participate in this research study because you are being treated at the UCSF Graduate Endodontics department for an endodontic procedure. We are trying to determine the treatment outcomes of one v. two-visit endodontic treatments. .If you decide to continue, we would like to request your consent for a follow up period of 1 year to observe the healing of the abscess. Observation periods occur at 6 months following the completion of the root canal and at 12 months and are a part of the standard of care. We will review findings in the Axium chart, which will be recorded by the treating doctor
Read the detailed description
This research study includes patients who are receiving endodontic treatment within the UCSF Graduate Endodontics Department. The purpose of the study is to evaluate and compare treatment outcomes between one-visit and two-visit root canal procedures. Participants who choose to continue in the study will be followed for a period of one year so that healing of the periapical abscess can be monitored. Follow-up appointments are scheduled at six months and twelve months after treatment completion, both of which are part of routine standard care. Clinical and radiographic findings documented in the Axium chart by the treating provider will be reviewed as part of the study analysis.
- Conditions
- Endodontic Infection, Periapical Periodontitis
- Being tested
- Calcium Hydroxide (CH), control group
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium Hydroxide (CH)Other
calcium hydroxide will be used as interim medication in the first visit and patients will return for the obturation in the second visit.
control groupOther
control group- no intervention
| Study group | Role | What they receive |
|---|---|---|
| One-visit endodontic treatment | Experimental | In this arm, obturation will be completed using a single-cone technique after cleaning and shaping. Receives: Other: control group |
| multiple visits endodontic treatment | Experimental | in this arm the endodontic therapy will be completed in multiple visits. Receives: Other: Calcium Hydroxide (CH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and Radiographic Healing
The primary outcome was defined using a combined clinical and radiographic healing based on the Cone-Beam Computed Tomography Periapical Index (CBCT-PAI)
Measured: 12 months
Secondary outcomes (1)
Volumetric Change in Periapical Lesion Size
The secondary outcome was defined as the change in lesion volume (mm³) between baseline and follow-up CBCT scans, serving as a quantitative metric of periapical healing
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start1 Sep 2021
- Primary completion1 Jul 2023
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endodontic InfectionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07354373
- Sponsor's protocol ID
- Ucsfendo
- Acronym
- RCT
- Status last verified
- Jan 2026
- First submitted
- 5 Dec 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
1. Siqueira JF Jr, Rôças IN. Clinical implications and microbiology of bacterial persistence after treatment procedures. J Endod 2008;34:1291-1301. 2. Tait C, Camilleri J, Blundell K. Non-surgical endodontics: obturation. Br Dent J 2025;238:487-496. 3. Schwendicke F, Göstemeyer G. Cost-effectiveness of single- versus multistep root canal treatment. J Endod 2016;42:1446-1452. 4. Makanjuola JO, Umesi DC, Oderinu OH. Comparison of the incidence of flare-up and time efficiency in single-visit root canal treatment employing either rotary or manual step-back canal preparatory technique. Niger Postgrad Med J 2018;25:100-104. 5. Ricucci D, Siqueira JF Jr. Biofilms and apical periodontitis: prevalence and association with clinical and histopathologic findings. J Endod 2010;36:1277-1288. 6. Siqueira JF Jr. Reaction of periradicular tissues to root canal treatment: benefits and drawbacks. Endod Topics 2005;10:123-147. 7. Shuping GB, Ørstavik D, Sigurdsson A, Trope M. Reduction of intracanal bacteria using nickel-titanium rotary instrumentation and various medications. J Endod 2000;26:751-755. 8. Sjögren U, Figdor D, Spångberg L, Sundqvist G. The antimicrobial effect of calcium hydroxide as a short-term intracanal dressing. Int Endod J 1991;24:119-125. 9. Tronstad L, Andreasen JO, Hasselgren G, et al. pH changes in dental tissues after root canal filling with calcium hydroxide. J Endod 1981;7:17-21. 10. Ng YL, Mann V, Rahbaran S, et al. Outcome of primary root canal treatment: systematic review-Part 2. Influence of clinical factors. Int Endod J 2008;41:6-31. 11. Mergoni G, Ganim M, Lodi G, et al. Single versus multiple visits for endodontic treatment of permanent teeth. Cochrane Database Syst Rev 2022;12:CD004450. 12. Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. J Pharmacol Pharmacother 2010;1:100-107. 13. Estrela C, Bueno MR, Azevedo BC, et al. A new periapical index based on cone-beam computed tomogr
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Single-Visit and Two-Visit Endodontic Treatments for Necrotic Teeth With Apical Periodontitis
- ClinicalTrials.gov ID
- NCT07354373
- Acronym / sponsor ID
- RCT / Ucsfendo
- Conditions
- Endodontic Infection, Periapical Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 21 Jan 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.
You are being asked to participate in this research study because you are being treated at the UCSF Graduate Endodontics department for an endodontic procedure. We are trying to determine the treatment outcomes of one v. two-visit endodontic treatments. .If you decide to continue, we would like to request your consent for a follow up period of 1 year to observe the healing of the abscess. Observation periods occur at 6 months following the completion of the root canal and at 12 months and are a part of the standard of care. We will review findings in the Axium chart, which will be recorded by the treating doctor
Detailed description
This research study includes patients who are receiving endodontic treatment within the UCSF Graduate Endodontics Department. The purpose of the study is to evaluate and compare treatment outcomes between one-visit and two-visit root canal procedures. Participants who choose to continue in the study will be followed for a period of one year so that healing of the periapical abscess can be monitored. Follow-up appointments are scheduled at six months and twelve months after treatment completion, both of which are part of routine standard care. Clinical and radiographic findings documented in the Axium chart by the treating provider will be reviewed as part of the study analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One-visit endodontic treatment | Experimental | Other: control groupIn this arm, obturation will be completed using a single-cone technique after cleaning and shaping. |
| multiple visits endodontic treatment | Experimental | Other: Calcium Hydroxide (CH)in this arm the endodontic therapy will be completed in multiple visits. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Classified as American Society of Anesthesiologists (ASA) Class I or II
- presenting with radiographic evidence of apical periodontitis-defined as a Cone-Beam Computed Tomography Periapical Index (CBCTPAI) score of 3 or greater according to the Estrela classification
Key exclusion criteria (9 listed)
- Exclusion criteria included patients with uncontrolled chronic systemic conditions (e.g., diabetes, hypertension, chronic obstructive pulmonary disease), cardiovascular disease, renal or hepatic impairment, and autoimmune disorders
- History of smoking
- Periodontal disease with probing depths ≥ 3 mm.
- Root fractures
- Immature apices
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 |
|---|---|---|
| Calcium Hydroxide (CH)calcium hydroxide will be used as interim medication in the first visit and patients will return for the obturation in the second visit. | Other | multiple visits endodontic treatment |
| control groupcontrol group- no intervention | Other | One-visit endodontic treatment |
Primary outcome
Clinical and Radiographic Healing
Time frame: 12 months
The primary outcome was defined using a combined clinical and radiographic healing based on the Cone-Beam Computed Tomography Periapical Index (CBCT-PAI)
1 secondary outcome
Volumetric Change in Periapical Lesion Size
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Background1. Siqueira JF Jr, Rôças IN. Clinical implications and microbiology of bacterial persistence after treatment procedures. J Endod 2008;34:1291-1301. 2. Tait C, Camilleri J, Blundell K. Non-surgical endodontics: obturation. Br Dent J 2025;238:487-496. 3. Schwendicke F, Göstemeyer G. Cost-effectiveness of single- versus multistep root canal treatment. J Endod 2016;42:1446-1452. 4. Makanjuola JO, Umesi DC, Oderinu OH. Comparison of the incidence of flare-up and time efficiency in single-visit root canal treatment employing either rotary or manual step-back canal preparatory technique. Niger Postgrad Med J 2018;25:100-104. 5. Ricucci D, Siqueira JF Jr. Biofilms and apical periodontitis: prevalence and association with clinical and histopathologic findings. J Endod 2010;36:1277-1288. 6. Siqueira JF Jr. Reaction of periradicular tissues to root canal treatment: benefits and drawbacks. Endod Topics 2005;10:123-147. 7. Shuping GB, Ørstavik D, Sigurdsson A, Trope M. Reduction of intracanal bacteria using nickel-titanium rotary instrumentation and various medications. J Endod 2000;26:751-755. 8. Sjögren U, Figdor D, Spångberg L, Sundqvist G. The antimicrobial effect of calcium hydroxide as a short-term intracanal dressing. Int Endod J 1991;24:119-125. 9. Tronstad L, Andreasen JO, Hasselgren G, et al. pH changes in dental tissues after root canal filling with calcium hydroxide. J Endod 1981;7:17-21. 10. Ng YL, Mann V, Rahbaran S, et al. Outcome of primary root canal treatment: systematic review-Part 2. Influence of clinical factors. Int Endod J 2008;41:6-31. 11. Mergoni G, Ganim M, Lodi G, et al. Single versus multiple visits for endodontic treatment of permanent teeth. Cochrane Database Syst Rev 2022;12:CD004450. 12. Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. J Pharmacol Pharmacother 2010;1:100-107. 13. Estrela C, Bueno MR, Azevedo BC, et al. A new periapical index based on cone-beam computed tomogr
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calcium Hydroxide (CH) in people with Endodontic Infection and Periapical Periodontitis, run by University of California, San Francisco at 1 site in United States.
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 2 inclusion and 9 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: finished, as of the sponsor's last update on 21 Jan 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical and Radiographic Healing (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07354373, which also lists 1 linked publication.
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 21 Jan 2026.