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NCT06447519
Multiple-Visit RCT in Teeth With SAP: Interappointment Dressing or Not?
Conditions: Endodontically Treated Teeth, Calcium Hydroxide
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 110
Sponsor: Aristotle University Of Thessaloniki
Location: School of Dentitry, Aristotle University of Thessaloniki Thessaloniki Central Macedonia
Summary
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.
Eligibility 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.
Source: ClinicalTrials.gov (NCT06447519). StuddyBuddy aggregates publicly available trial information.