Evaluating Calcium Hydroxide in Treating Infected Teeth
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
This study is testing if using calcium hydroxide in treating infected teeth helps people heal better and feel less pain compared to not using it during their dental visits.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aristotle University Of Thessaloniki Academic / other |
| Locations | 1 site (Thessaloniki, Central Macedonia) |
| Trial ID | NCT06447519 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the effectiveness of calcium hydroxide as an intracanal medicament in the healing of periapical tissues in teeth diagnosed with symptomatic apical periodontitis. Participants will undergo multiple-visit endodontic treatment, with one group receiving calcium hydroxide dressing and the other group having no dressing between appointments. The study will evaluate clinical and radiographic outcomes over a follow-up period of 6 to 24 months, including postoperative pain levels and the use of analgesics. The trial will also monitor the incidence of flare-ups during the treatment process.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with symptomatic apical periodontitis in permanent teeth.
Not a fit: Patients who are pregnant, have received corticosteroids or antibiotics recently, or have teeth that cannot be treated due to anatomical issues will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve healing outcomes for patients with symptomatic apical periodontitis undergoing endodontic treatment.
How similar studies have performed: Previous studies have shown varying success with calcium hydroxide in endodontic treatments, but this specific approach is being evaluated for its effectiveness in a controlled setting.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Thessaloniki, Central Macedonia
- School of Dentitry, Aristotle University of Thessaloniki — Thessaloniki, Central Macedonia, Greece (Recruiting)
Study contacts
- Study coordinator: Konstantinos Kodonas, Ass.Prof.
- Email: kkodonas@dent.auth.gr
- Phone: 00302310999592
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.