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

Launched by ARISTOTLE UNIVERSITY OF THESSALONIKI · Jun 2, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a medication called calcium hydroxide in treating teeth with a condition known as symptomatic apical periodontitis. This condition is often painful and occurs when the area around the tooth's root becomes infected. The trial will involve patients undergoing multiple visits for endodontic treatment (commonly known as a root canal). Some participants will receive calcium hydroxide inside their tooth between appointments, while others will have their tooth left empty during this time. Researchers will follow up with participants for 6 to 24 months after treatment to see how well their teeth heal and to assess any pain they experience.

To join the study, participants must be at least 18 years old, have a diagnosed tooth infection, and be in generally good health (ASA grade I or II). However, pregnant women and those with certain medical conditions or recent treatments may not be eligible. Participants will rate their pain levels before and after each treatment session, and the study will also look at how many people experience pain flare-ups or need pain relief medication. This trial is currently recruiting, providing an opportunity for those dealing with tooth pain to potentially receive a new treatment option while contributing to medical research.

Gender

ALL

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.