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

February 9, 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

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

110

Phase

  • 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 Locations

  • Greece
    • Central Macedonia
      • Thessaloniki, Central Macedonia, Greece, 54124
        • Recruiting
        • School of Dentitry, Aristotle University of Thessaloniki
        • Contact:
        • Contact:
        • Principal Investigator:
          • Athanasios Theodorides, Postgraduate Student
        • Principal Investigator:
          • Eirini Katmerou, Postgraduate Student
        • Sub-Investigator:
          • Christos Gogos, Professor

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

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
Intervention / Treatment
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

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

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

Aristotle University Of Thessaloniki

Investigators

  • 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)

September 12, 2024

Primary Completion (Estimated)

September 12, 2026

Study Completion (Estimated)

September 12, 2026

Study Registration Dates

First Submitted

May 27, 2024

First Submitted That Met QC Criteria

June 2, 2024

First Posted (Actual)

June 7, 2024

Study Record Updates

Last Update Posted (Actual)

February 10, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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