Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06447519

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

Led by Aristotle University Of Thessaloniki · Updated on 2026-02-10

110

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of calcium hydroxide as an intracanal medication to help heal periapical tissues in permanent teeth diagnosed with symptomatic apical periodontitis. The study compares calcium hydroxide treatment with leaving the root canal empty between appointments during multiple-visit endodontic treatment. The goal is to assess clinical and radiographic healing over a follow-up period of 6 to 24 months. Postoperative pain and flare-ups are also monitored as secondary outcomes. During the first visit, local anesthesia is given, decayed tissue is removed, and the tooth is prepared for root canal treatment with cleaning and irrigation. Participants are divided into two groups: one receives calcium hydroxide paste inside the root canal for 7 to 10 days, and the other has the canal left empty for the same period. Both groups receive a temporary restoration. In the final visit, the dressing is removed if present, and the canal is filled and temporarily restored again before referral for a permanent restoration. Participants will attend multiple visits for treatment and follow-up assessments. Pain levels will be recorded using a numerical scale before and after each session, and analgesic use will be tracked. Clinical examinations, radiographic imaging, and evaluations of tooth and tissue healing will be conducted over 6 to 24 months. The study will also monitor flare-up incidence up to 3 days after each appointment to evaluate safety and treatment effects.

CONDITIONS

Brief Title

Multiple-Visit RCT in Teeth With SAP: Interappointment Dressing or Not?

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • ASA grade I or II
  • Age 18 years or older
  • Permanent teeth
  • Pulp diagnosis of necrosis or previously treated
  • Diagnosis of symptomatic apical periodontitis
  • Teeth sensitive to percussion and/or palpation
  • Initial periapical index (PAI) score between 3 and 5
  • Signed patient consent for participation in clinical research
Not Eligible

You will not qualify if you...

  • Not meeting the inclusion criteria
  • Pregnant women
  • Use of corticosteroids or antibiotics within the previous three months
  • Pain in a different area than the tooth being studied
  • Teeth that cannot be isolated with a rubber dam
  • Teeth with extensive hard tissue destruction that cannot be restored
  • Teeth with root canal anatomical abnormalities (internal resorption, perforation, displacement)
  • Teeth with incomplete root apex formation
  • Fractured teeth with periodontal involvement
  • Teeth with periodontal pocket depth 4 mm or greater or bone loss at root bifurcation due to periodontitis
  • Teeth with periodontal attachment loss of 5 mm or greater
  • Teeth with embedded exudate at the time of root canal obturation
  • Teeth showing significant under- or over-extension from the radiographic apex after treatment
  • Teeth without permanent restoration completed within one month after endodontic treatment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 7 to 14 days

Participants receive non-surgical root canal treatment in multiple visits. The first visit includes local anesthesia, decay removal, root canal instrumentation, and either placement of an intracanal dressing with calcium hydroxide or no dressing. Teeth are temporarily restored. After 7 to 10 days, the final visit includes removal of any intracanal dressing if used, root canal obturation, and temporary restoration, followed by referral for final restoration within 7 to 14 days.

2 visits (in-person)

Trial Site Locations

Total: 1 location

1

School of Dentitry, Aristotle University of Thessaloniki

Thessaloniki, Central Macedonia, Greece, 54124

Actively Recruiting

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Research Team

K

Konstantinos Kodonas, Ass.Prof.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Success rate of single- versus two-visit root canal treatment of teeth with apical periodontitis: a randomized controlled trial.

Jorge Paredes-Vieyra, Francisco Javier Jimenez Enriquez

https://pubmed.ncbi.nlm.nih.gov/22892729

Effectiveness of root canal irrigation and dressing for the treatment of apical periodontitis: A systematic review and meta-analysis of clinical trials.

Giampiero Rossi-Fedele, Tina Rödig

https://pubmed.ncbi.nlm.nih.gov/35579074