NCT07480226

Brief Summary

The goal of this clinical trial is to learn whether regenerative endodontic treatment (RET) should be performed in one visit or two visits in people with mature permanent teeth with chronic apical periodontitis. RET is a dental treatment used for teeth with necrotic pulp and infection around the root. The procedure disinfects the root canal and promotes the formation of new tissue inside the canal space, which may support healing of the tissues around the tooth root. The main questions this study aims to answer are: Does single-visit RET cause different levels of postoperative pain compared with two-visit RET? Do teeth treated with single-visit or two-visit RET show different levels of healing around the root? Participants will receive RET using either a single-visit or two-visit treatment protocol. Participants will record their pain levels during the first week after treatment using a visual analog scale (VAS). Participants will return for follow-up visits at six months and one year, when dental radiographs will be taken to evaluate healing around the tooth root.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

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, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 13, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 18, 2026

Completed
Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

1.4 years

First QC Date

March 13, 2026

Last Update Submit

March 13, 2026

Conditions

Chronic Apical Periodontitis

Outcome Measures

Primary Outcomes (2)

  • Primer success

    Primary success is defined as the absence of clinical symptoms and evidence of periapical healing on radiographs.

    12 months

  • Secondary success

    Positive response to electric pulp testing is assessed.

    12 months

Secondary Outcomes (4)

  • Postoperative Pain

    8 hours, 24 hours, 48 hours, and 7 days after each treatment visit

  • Periapical Lesion Area

    Baseline and 12 months

  • Mean Gray Value

    Baseline and 12 months

  • Fractal Dimension

    Baseline and 12 months

Study Arms (2)

Single-Visit RET

EXPERIMENTAL
Procedure: Single-Visit Regenerative Endodontic Treatment

Multiple-Visit RET

EXPERIMENTAL
Procedure: Multiple-Visit Regenerative Endodontic Treatment

Interventions

Single-Visit Regenerative Endodontic TreatmentPROCEDURE

Regenerative endodontic treatment was performed in a single clinical visit in mature permanent teeth diagnosed with chronic apical periodontitis. During the procedure, the root canal system was cleaned through chemomechanical preparation using mechanical instrumentation and irrigation solutions. Apical bleeding was then induced to create a biological scaffold within the canal space. A mineral trioxide aggregate (MTA) coronal barrier was placed over the blood clot. After the setting of MTA, the access cavity was restored with a definitive coronal restoration the following day.

Single-Visit RET
Multiple-Visit Regenerative Endodontic TreatmentPROCEDURE

Regenerative endodontic treatment was performed in multiple clinical visits in mature permanent teeth diagnosed with chronic apical periodontitis. During the first visit, the root canal system was cleaned through chemomechanical preparation using mechanical instrumentation and irrigation solutions, and an intracanal medicament was placed. At the second visit, the intracanal medicament was removed and apical bleeding was induced to create a biological scaffold within the canal space. MTA coronal barrier was placed over the blood clot. After the setting of MTA, the access cavity was restored with a definitive coronal restoration the following day.

Multiple-Visit RET

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University Faculty of Dentistry

Istanbul, Istanbul, Turkey (Türkiye)

Location

Related Publications (2)

  • Youssef A, Ali M, ElBolok A, Hassan R. Regenerative endodontic procedures for the treatment of necrotic mature teeth: A preliminary randomized clinical trial. Int Endod J. 2022 Apr;55(4):334-346. doi: 10.1111/iej.13681. Epub 2022 Jan 31.

    PMID: 35030270RESULT

  • Arslan H, Ahmed HMA, Sahin Y, Doganay Yildiz E, Gundogdu EC, Guven Y, Khalilov R. Regenerative Endodontic Procedures in Necrotic Mature Teeth with Periapical Radiolucencies: A Preliminary Randomized Clinical Study. J Endod. 2019 Jul;45(7):863-872. doi: 10.1016/j.joen.2019.04.005. Epub 2019 May 31.

    PMID: 31155298RESULT

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

March 13, 2026

First Posted

March 18, 2026

Study Start

September 1, 2024

Primary Completion

January 30, 2026

Study Completion

January 30, 2026

Last Updated

March 18, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)