Chronic Periapical Periodontitis, Periapical Abscess, Periapical Periodontitis, Pulp Necrosis, Pulp Necrosis, Apical Periodontitis
Conditions
Keywords
Periapical periodontitis, Calcium silicate based sealer (CSBS), Dia-Root Bio Sealer, Obturation techniques, root canal obturation
Brief summary
The study aims to evaluate the efficiency of using a Calcium silicate-based sealer (CSBS) with different obturation techniques in treating root canals with apical periodontitis in single visit. Evaluating: 1. Postoperative healing. 2. Preoperative, postoperative pain and frequency of analgesic intake.
Detailed description
Evaluation of Dia-Root Bio Sealer (CSBS) using the three known obturation techniques; Single cone (SC) technique, Warm vertical compaction (WVC) technique, and Cold lateral compaction (CLC) technique.
Interventions
DEVICEDia-Root Bio Sealer
The sealer will be delivered in the canals with the provided intracanal tips inserted three millimeters from the WL and back filling until the orifice. The pre-fitted master cone will be inserted with slight up and down motion before reaching the WL.
PROCEDURESingle cone (SC) Obturation technique
Filling the prepared root canal with the master cone and the CSBS. Then cutting the excess gutta percha from the root canal orifice
PROCEDUREWarm Vertical compaction (WVC) technique
After placing the CSBS intside the RC, the cone will be packed down till 4 mm from the apex for 4 seconds cycles. Then the apical GP will be condensed using pluggers previously fitted inside the canal. Canals will be backfilled with 180C temperature setting. The tip will be placed into the root canal against the apical gutta-percha for 5 s before extruding the gutta-percha on increments. The middle and coronal thirds will be condensed using pre-fitted pluggers.
PROCEDURECold lateral condensation (CLC) technique
After placing the CSBS inside the root canal, the master GP cone will be laterally condensed with a pre-selected spreader inserted 2-4 mm from the WL and accessory GP cone will be placed in the provided space by the spreader. This process will be repeated until 1 mm from the canal orifice. Excess GP will be cut at the orifice with a heat carrier and lightly packed vertically with a plugger.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Medical condition: Medically free patients. * Age: Ranging from 20-50 years old * Gender: Male and female patients * Teeth: Patients with mandibular permanent mature molar(s) diagnosed with necrotic pulps and with apical periodontitis (asymptomatic, symptomatic apical periodontitis, or chronic periapical abscess), with at least one of the roots showing radiographic evidence of periapical lesion. * Preoperative radiographic (CBCT) lesion size should range from 2 - 4 mm. * Patients who fulfill these criteria, agree to participate, and sign the informed consent
Exclusion criteria
* Participants with generalized periodontal disease, and those who are pregnant, breastfeeding, or have any systemic disease. * Teeth diagnosed with immature apices, root resorption, or non-restorable. * Patients in which the clinical assessment necessitates multiple-visits treatment, such as those with signs and symptoms of acute or diffuse infection. * Patients who had pre-treatment antibiotic therapy or analgesics and within 7 days. * Patients who fail to complete their final restoration postoperatively. * Patients who will refuse to sign the informed consent. * Root canals requiring apical preparation larger the #40.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success of healing and healing rate of the periapical lesion after one year | 6 and 12 months postoperatively | Periapical bone healing will be evaluated using Cone Beam Computed Tomography (CBCT) images scored according to the CBCT Periapical Index (CBCT-PAI). Success is defined as a CBCT-PAI score of 0 (healthy) or a significant reduction in the volumetric size of the periapical radiolucency compared to the preoperative baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Postoperative Pain Intensity | Preoperative (Baseline) and 72 hours postoperative | The change in patient-reported pain intensity from baseline. Pain is evaluated using a 0 to 100 mm Visual Analog Scale (VAS), where 0 represents 'no pain' and 100 represents 'the worst imaginable pain' Patients will be asked not to use analgesic medication after treatment until needed. If necessary, the patient will be instructed to record pain score before analgesic administration and record the dose and frequency of intake (by hour) of the analgesic and to submit this information after 72 h. |
Countries
Egypt
Contacts
STUDY_DIRECTORMohammed M Nagy, Professor
Faculty of Dentistry, Ain Shams University
STUDY_CHAIRSara H Fahmy, Lecturer of Endodontics
Faculty of Dentistry, Ain Shams University
Outcome results
None listed