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Clinical Trials in Turkey / NCT07307807
Active, not recruiting Not applicable

Evaluation of Postoperative Pain and Lesion Healing in Periapical Lesion-Affected Teeth Obturated With Different Root Canal Sealers

NCT07307807 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2025-06-01
Last updated
2025-12-29

Condition(s) studied

Root Canal ObturationApical Periodontitis

Investigational drug(s) / intervention(s)

AH Plus and PAI 2-3AH Plus and PAI 4TotalFill BC Sealer and PAI 2-3TotalFill BC Sealer and PAI 4

AH Plus and PAI 2-3: The AH Plus root canal sealer, mixed in accordance with the manufacturer's instructions, will be applied together with master cones into root canals with PAI scores of 2-3. Control periapical radiographs will be obtained to evaluate the quality of the root canal fillings. Volunteers will be asked to record the pain they experience before treatment and at the 6th, 12th, 24th, 36th, 48th, and 72nd hours, as well as 1 week after treatment, using a Visual Analog Scale (VAS) form. One week after treatment, volunteers will be contacted by telephone, and the pain scores recorded on the pain assessment forms will be entered into the patient records. Six months after completion of the endodontic treatment, volunteers will be contacted by telephone and recalled for follow-up. Control periapical radiographs will be obtained from the volunteers, and healing will be evaluated.

AH Plus and PAI 4: The AH Plus root canal sealer, mixed in accordance with the manufacturer's instructions, will be applied together with master cones into root canals with PAI score of 4. Control periapical radiographs will be obtained to evaluate the quality of the root canal fillings. Volunteers will be asked to record the pain they experience before treatment and at the 6th, 12th, 24th, 36th, 48th, and 72nd hours, as well as 1 week after treatment, using a Visual Analog Scale (VAS) form. One week after treatment, volunteers will be contacted by telephone, and the pain scores recorded on the pain assessment forms will be entered into the patient records. Six months after completion of the endodontic treatment, volunteers will be contacted by telephone and recalled for follow-up. Control periapical radiographs will be obtained from the volunteers, and healing will be evaluated

TotalFill BC Sealer and PAI 2-3: The TotalFill BC root canal sealer, mixed in accordance with the manufacturer's instructions, will be applied together with master cones into root canals with PAI scores of 2-3. Control periapical radiographs will be obtained to evaluate the quality of the root canal fillings. Volunteers will be asked to record the pain they experience before treatment and at the 6th, 12th, 24th, 36th, 48th, and 72nd hours, as well as 1 week after treatment, using a Visual Analog Scale (VAS) form. One week after treatment, volunteers will be contacted by telephone, and the pain scores recorded on the pain assessment forms will be entered into the patient records. Six months after completion of the endodontic treatment, volunteers will be contacted by telephone and recalled for follow-up. Control periapical radiographs will be obtained from the volunteers, and healing will be evaluated.

TotalFill BC Sealer and PAI 4: The AH Plus root canal sealer, mixed in accordance with the manufacturer's instructions, will be applied together with master cones into root canals with PAI score of 4. Control periapical radiographs will be obtained to evaluate the quality of the root canal fillings. Volunteers will be asked to record the pain they experience before treatment and at the 6th, 12th, 24th, 36th, 48th, and 72nd hours, as well as 1 week after treatment, using a Visual Analog Scale (VAS) form. One week after treatment, volunteers will be contacted by telephone, and the pain scores recorded on the pain assessment forms will be entered into the patient records. Six months after completion of the endodontic treatment, volunteers will be contacted by telephone and recalled for follow-up. Control periapical radiographs will be obtained from the volunteers, and healing will be evaluated.

Study summary

The root canal treatment of volunteers with asymptomatic apical periodontitis will be completed using TotalFill BC and AH Plus root canal sealers, and postoperative pain as well as healing will be comparatively evaluated through radiographic follow-ups at predetermined time intervals.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: 1. Healthy individuals aged between 18 and 60 years with no systemic diseases 2. Teeth with periapical lesions (apical periodontitis) that have not undergone previous root canal treatment 3. Single-rooted maxillary and mandibular teeth 4. Teeth with PAI scores of 2, 3, and 4 according to the PAI classification 5. Teeth without a sinus tract or acute apical abscess 6. Patients who voluntarily agree to participate in the study and attend follow-up visits 7. Teeth with sufficient remaining tooth structure to allow restoration with a direct restoration after root canal treatment - Exclusion Criteria: Patients who have used antibiotics, analgesics, or anti-inflammatory drugs within the last 7 days Pregnant or breastfeeding patients Patients with traumatic malocclusion Patients without occlusal contact Teeth with root resorption, open apices, or calcification Teeth presenting gingival recession greater than 3 mm, deep periodontal pockets, or mobility Teeth with root fractures or cracks Presence of an adjacent tooth requiring endodontic treatment that may cause referred pain Multirooted teeth Teeth with a PAI score of 5 Teeth requiring restorations such as endocrowns, onlays, overlays, or full crowns due to excessive loss of tooth structure after root canal treatment Teeth with structural loss severe enough to require post-core application Cases in which adequate anesthesia cannot be achieved with local anesthesia alone (requiring additional intrapulpal or intraligamentary anesthesia) Teeth requiring active periodontal treatment Individuals with severe systemic diseases \-

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Ankara Yıldırım Beyazıt University Ankara Keçiören

More Ankara Yildirim Beyazıt University trials in Turkey

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07307807 on ClinicalTrials.gov ↗ ← All trials in Turkey