Apical Periodontitis, Root Canal Obturation
Conditions
Keywords
AH Plus, TotalFill BC Sealer, Postoperative pain, Fractal analysis, Visual Analog Scale (VAS)
Brief 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.
Detailed description
The study is planned as a randomized controlled clinical trial. The randomized controlled study will be conducted at the Ankara Yıldırım Beyazıt University Faculty of Dentistry, Department of Endodontics, and will include adult volunteers who have been diagnosed with asymptomatic apical periodontitis, present periapical lesions with PAI scores of 2, 3, and 4, have an indication for root canal treatment, meet the inclusion criteria of the study, and have provided written informed consent. Volunteers will be randomly selected from patients attending our clinic according to lesion size. A computer-assisted randomization method (www.randomizer.org) will be used. Root canal treatments will be completed using AH Plus or TotalFill BC root canal sealers. The required sample size will consist of a total of 64 volunteers: 16 volunteers with PAI 2-3 scored teeth treated with AH Plus, 16 volunteers with PAI 4 scored teeth treated with AH Plus, 16 volunteers with PAI 2-3 scored teeth treated with TotalFill BC, and 16 volunteers with PAI 4 scored teeth treated with TotalFill BC. After completion of the root canal treatments, postoperative radiographs will be obtained and follow-up will be performed at 6 months. Postoperative pain will be assessed at the 6th, 12th, 24th, 36th, 48th, and 72nd hours, as well as at 1 week following completion of the root canal treatment.
Interventions
PROCEDUREAH 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.
PROCEDUREAH 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
PROCEDURETotalFill 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.
PROCEDURETotalFill 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.
Sponsors
Ankara Yildirim Beyazıt University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The bioistatician performing the data analysis will be blinded to group allocation. The clinician performing the treatments will not be blinded.
Eligibility
Sex/Gender
ALL
Age
18 Years to 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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fractal analysis | 6. month | In this study, fractal analysis of each sample will be performed using the box-counting method. |
| VAS scala | 6.,12.,24.,36.,48.,72. hours and 1 week | 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, on a form using the Visual Analog Scale (VAS). One week after treatment, volunteers will be contacted by telephone, and the pain scores indicated on the pain assessment forms will be obtained and recorded in the patient files. |
Countries
Turkey (Türkiye)
Outcome results
None listed