Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-25 @ 4:18 AM
NCT ID:
NCT07237620
Brief Summary:
This study is planned to evaluate the effects of two different intracanal medicaments-calcium hydroxide and diclofenac sodium-on periapical healing following endodontic retreatment. Fifty-four patients will be included and randomly assigned into two groups according to the type of medicament used. All procedures will be performed by a single experienced endodontist under standardized clinical conditions. Periapical lesion healing will be assessed radiographically at baseline and after 12 months using fractal analysis to quantitatively evaluate bone regeneration. The primary outcome will be the change in the fractal dimension values between the initial and follow-up radiographs.
Detailed Description:
Removal of Previous Root Canal Filling All stages of the root canal procedure are to be performed by a single endodontist with seven years of clinical experience. Local anesthesia is to be achieved with supraperiosteal infiltration of 4% articaine containing 1:100,000 epinephrine (Ultracain D-S; Sanofi, Paris, France). The tooth is to be isolated with a rubber dam, and canal access is to be achieved through a conventional access cavity. The filling material in the access cavity is to be removed using a water-cooled diamond fissure bur.
Root filling material is to be removed using ProTaper Universal Retreatment files operated at 500 rpm. D1 (30/0.09), D2 (25/0.08), and D3 (20/0.07) files are to be used in the coronal, middle, and apical thirds, respectively. Apical patency is to be verified, and the master apical file (MAF) is to be used up to the working length, which is to be determined when the electronic apex locator (Morita Root ZX, Tokyo, Japan) displays "0.0" and confirmed radiographically.
The MAF is to be selected according to the canal volume, and canal preparation is to be completed. Retreatment is to be considered complete when no residual filling material is observed radiographically.
Medication Application and Randomization Patients are to be randomly assigned into two groups (Ca(OH)₂ and DCS) using block randomization technique (allocation ratio 1:1) via www.randomizer.org. The intracanal medicaments are to be prepared by an independent clinician not involved in the study. Both the operator and the patient are to be blinded to the type of medicament used. The medicaments will have similar appearance, color, and consistency to maintain blinding.
Group 1: 1 g of CH (Kalsin, Konya, Turkey) is to be mixed with 1 mL of distilled water.
Group 2: 1 g of DCS (Fagron, Rotterdam, Netherlands) is to be mixed with 1 mL of distilled water.
After preparation, the medicaments are to be placed into the canal using a lentulo spiral (Dentsply Sirona, Switzerland) set 2 mm short of the working length. The medicament is to be condensed to the canal orifice with a sterile paper point. The canals are to be sealed with a sterile cotton pellet and Cavit (3M ESPE, Seefeld, Germany).
Patients are to be prescribed 400 mg ibuprofen if needed and provided with a contact number for emergency communication in case of persistent or severe pain.
Removal of Medicaments and Root Canal Filling One week later, under rubber dam isolation, the access cavity is to be reopened. The intracanal medicaments are to be removed mechanically using the MAF and irrigation with a total of 10 mL NaOCl. The final irrigation sequence is to consist of 5 mL saline, 3 mL 17% EDTA (1 minute), 5 mL saline, 5 mL 2.5% NaOCl, and a final rinse with 5 mL saline.
All canals are to be obturated using the lateral condensation technique with Bioserra sealer (Dentsply DeTrey GmbH, Konstanz, Germany). All endodontic procedures are to be performed by a single endodontist.
Follow-up and Outcome Evaluation The primary outcome is to be the reduction in periapical lesion volume, which will be assessed by fractal analysis of periapical radiographs obtained before treatment and at the 12-month follow-up. The images are to be analyzed by two blinded evaluators.
Patients are to be recalled after one year for clinical and radiographic evaluation. Clinical signs and symptoms (tenderness to percussion or palpation, pain, deep periodontal pockets, sinus tract, or swelling) are to be recorded Digital radiographs are to be obtained using the same X-ray holder, and standardized exposure settings to ensure consistent diagnostic quality.
All patients are to be invited for an additional follow-up after an average postoperative period of four years. Restorations are to be evaluated clinically and expected to remain of good quality throughout the observation period.
Fractal Analysis Baseline and one-year follow-up digital periapical radiographs of the teeth are to be obtained using a periapical radiography device equipped with standard size #2 photostimulable phosphor plates.
All analyses are to be performed by an experienced dentomaxillofacial radiologist who will be blinded to the group allocation.
Study:
NCT07237620
Study Brief:
Protocol Section:
NCT07237620