NCT07354373

Brief 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. .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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 21, 2026

Completed
Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

1.8 years

First QC Date

December 5, 2025

Last Update Submit

January 14, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

    12 months

Secondary Outcomes (1)

  • Volumetric Change in Periapical Lesion Size

    12 months

Study Arms (2)

One-visit endodontic treatment

EXPERIMENTAL

In this arm, obturation will be completed using a single-cone technique after cleaning and shaping.

Other: control group

multiple visits endodontic treatment

EXPERIMENTAL

in this arm the endodontic therapy will be completed in multiple visits.

Other: Calcium Hydroxide (CH)

Interventions

calcium hydroxide will be used as interim medication in the first visit and patients will return for the obturation in the second visit.

multiple visits endodontic treatment

control group- no intervention

One-visit endodontic treatment

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • History of smoking
  • Periodontal disease with probing depths ≥ 3 mm.
  • Root fractures
  • Immature apices
  • Resorption
  • perforations
  • Inability to achieve rubber dam isolation
  • Lack of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California San Francisco School of dentistry

San Francisco, California, 94143, United States

Location

Related Publications (1)

  • 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

    BACKGROUND

MeSH Terms

Conditions

Periapical Periodontitis

Interventions

Calcium HydroxideControl Groups

Condition Hierarchy (Ancestors)

Periapical DiseasesJaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth DiseasesPeriodontitis

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsCalcium CompoundsAnionsIonsElectrolytesEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2025

First Posted

January 21, 2026

Study Start

September 1, 2021

Primary Completion

July 1, 2023

Study Completion

July 1, 2025

Last Updated

January 21, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations