Multiple-Visit RCT in Teeth With SAP: Interappointment Dressing or Not? (NCT06447519) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Multiple-Visit RCT in Teeth With SAP: Interappointment Dressing or Not?
Greece110 participantsStarted 2024-09-12
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 tha…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.