Multiple-Visit RCT in Teeth With SAP: Interappointment Dressing or Not? (RCTCa(OH)2)

June 11, 2026 updated by: Aristotle University Of Thessaloniki

Clinical and Radiographic Outcomes of Multiple-Visit Non-Surgical Root Canal Treatment in Permanent Teeth With Symptomatic Apical Periodontitis : Interappointment Dressing or Not? A Randomized Clinical Trial

The aim of the study is to evaluate the effectiveness of calcium hydroxide as an intracanal medicament in the clinical and radiographic healing of periapical tissues in teeth diagnosed with symptomatic apical periodontitis. This evaluation will be conducted after multiple visit endodontic treatment. The follow-up sessions will be programmed from 6 to 24 months postoperatively. Postoperative pain will also be considered as a secondary outcome. Participants will be asked to rate their pain level on a numerical scale from 0 to10 before and after each session of endodontic treatment. Additionally, the use of analgesics after the procedure will be measured and the incidence of flare-ups will be evaluated. Two study groups will be formed to undergo multiple-visit endodontic treatment. The intervention group will receive intracanal medication of calcium hydroxide, while the control group will have the root canal left empty between appointments.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The first visit will include the following clinical steps . After administering local anesthesia with 4% articaine hydrochloride and epinephrine injection (with 1:200,000 adrenaline) or 2% mepivacaine for an inferior alveolar block, all decayed tissue from the tooth will be removed. The tooth will be isolated with a rubber dam, the tooth crown will be disinfected with 2% NaOCl, and an access cavity preparation will be created. The #10 C-Pilot file will be used to create a glide path. The working length will be established with an apex locator and an x-ray. The root canal will be instrumented using the sequence of NiTi rotary files Edge Endo X7. The canals will be irrigated copiously with 10ml of 2% NaOCl each time. Following instrumentation, a final rinse with 10ml of 2% NaOCl, 10ml of 17% EDTA, and 10ml of saline solution will be performed. Group 1 will receive intracanal dressing with Ca (OH)2 paste using Lentulo for a period of 7-10 days. Group 2 will be left without intracanal dressing for a period of 7-10 days. In both groups, teeth will be restored with glass ionomer cement (GIC) as a temporary restoration. The final visit will include the following clinical steps. After examining the tooth and surrounding tissues, local anesthesia will be administered as previously described. The temporary restorative material will be removed, and the tooth will be isolated with a rubber dam before accessing the root canal. In Group 1, the intracanal dressing will be removed through irrigation, and then obturated using a standardized, matched size and taper gutta-percha cone with AH-plus sealer with the single-cone obturation technique. The tooth will be then temporarily restored with glass ionomer cement (GIC), and the participant will be referred for final restoration within 7-14 days. The same protocol is followed for Group 2.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
110

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Greece
    • Central Macedonia
      • Thessaloniki, Central Macedonia, Greece, 54124
        • School of Dentitry, Aristotle University of Thessaloniki

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ASA grade: I or II
  • Age: ≥18 years
  • Permanent teeth
  • Pulp diagnosis: necrosis or previously treated
  • Diagnosis of periapical tissues: symptomatic apical periodontitis
  • Teeth sensitive to percussion and/or palpation
  • Initial PAI: 3-5
  • Signed Patient Consent Statement for participation in clinical research

Exclusion Criteria:

  • Subjects that do not meet the inclusion criteria
  • Pregnant women
  • Patients who receive corticosteroids and/or have received antibiotics within the previous three months
  • Patients who report pain in a different area than that of the tooth under investigation
  • Teeth that cannot be isolated with a rubber dam
  • Teeth with extensive hard tissue destruction that is not restorable
  • Teeth with an anatomic peculiarity of the root canal (internal resorption, perforation, displacement of root canal course due to previous endodontic treatment)
  • Teeth in which the formation of the apex has not been completed
  • Fractured teeth with periodontal involvement
  • Teeth with periodontal pocket depth ≥ 4mm or teeth with bone loss at the bifurcation of the roots due to periodontitis
  • Teeth with loss of periodontal attachment ≥ 5 mm
  • Teeth with embedded exudate in the session planned for root canal obturation.
  • Teeth that after completion of the endodontic treatment show underocclusion >2mm or hyperobstruction >1mm from the radiographic apex.
  • Teeth in which permanent restoration has not been completed over time less than one month after endodontic treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Ca(OH)2 intracanal medicament
Ca(OH)2 intracanal medicament used for root canal disinfection as interapointment dressing.
Drug: Ca(OH)2 as intracanal medicament
Ca(OH2 will be used as intracanal medicament for the disinfection of the root canal between appointmnents
No Intervention: Standard of Care
No intracanal medicament. The root canal will be left empty without any intracanal dressing between appointments.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinical evidence of success
Time Frame: 6-24 months post-operatively
Criteria of clinical success include the absence of pain and tenderness to palpation and percussion and the absence of sinus or any associated soft tissue swelling. Failure is indicated by the presence of at least one of the abovementioned signs or symptoms.
6-24 months post-operatively
Radiographic evidence of success
Time Frame: 6-24 months post-operatively
Radiographic evidence of periapical healing will be evaluated by the improvement of Periapical Index score (PAI). The PAI system provides an ordinal scale of 5 scores ranging from 1 (healthy) to 5 ( severe periodontitis with exacerbating features). In detail PAI score 1 indicates normal periapical anatomy. PAI score 2 indicates mild changes in bone pattern. PAI score 3 is indicative by changes in bone pattern with diffuse loss of mineral. PAI score 4 is indicative of apical periodontitis with definite radiolucency in the periapical area. PAI score 5 indicates severe periodontitis with exacerbating features. Improvement of PAI score will be evaluated as success. Consequently a lower PAI score is indicative of success but a higher or stable PAI score is indicative of failure.
6-24 months post-operatively

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Flare-up incidence
Time Frame: 0 to 3 days after every single appointment
Patients will contact the primary investigator in case of pain or swelling that may appear after each appointment.
0 to 3 days after every single appointment
Postoperative pain assesment
Time Frame: 0 to 3 days after every single appointment
Description: Participants will be advised to follow analgesic medication of Ibuprofen (600mg) or Paracetamol (1000mg) treatment or combined medication only in case of feeling pain. Participants will be asked to rate the level of pain on a numerical rating scale from 0 to10 before the start and after 1, 2 and 3 days of each session. According to this scale 0 is indicative of "no pain" and 10 is indicative of "the worst pain ever felt". All intermediate scales are proportional to the pain of the patient. For example, 1 to 3 is indicative of mild pain, 4 to 6 moderate pain and 7 to 9 severe pain. Participants will also be given a paper form in which they must fill in the type and quantity of receiving analgesic medication for each of the first 3 days after each session of endodontic therapy. Besides the numerical pain scale the number of analgesic tablets will be also recorded.
0 to 3 days after every single appointment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aristotle University Of Thessaloniki

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Nikolaos Economides, Prof., School of Dentistry, Aristotle University of Thessaloniki

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 12, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 12, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 12, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 27, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 7, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 230/21-03-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Study Data/Documents

  1. Study Protocol
    Information comments: https://ikee.lib.auth.gr

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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