None listed
Conditions
Brief summary
This study will compare different intracanal medicaments used in the treatment of infected primary molar teeth in children aged 5–8 years. Participants will be randomly assigned to receive either a pure antibiotic intracanal dressing prepared from active pharmaceutical ingredients, an intracanal dressing prepared from commercially available antibiotic tablets, or a conventional calcium hydroxide dressing. The effectiveness of these treatments will be evaluated by measuring the reduction in bacterial load in root canals and by assessing postoperative pain and swelling. The study hypothesizes that the pure antibiotic intracanal dressing will reduce intracanal bacterial load more effectively than the commercial antibiotic preparation and calcium hydroxide.
Interventions
Group 1: Pure Antibiotic Intracanal Dressing (PURE-TAP) After standard access cavity preparation, chemomechanical debridement, and irrigation with sterile saline, a pure antibiotic intracanal dressing will be placed. The dressing consists of ciprofloxacin, metronidazole, and cefixime in equal proportions (1:1:1), prepared from pure active pharmaceutical ingredients without excipients. Each antibiotic is weighed (10 mg), mixed to form a homogeneous powder, and combined with sterile distilled water to obtain a paste consistency suitable for intracanal application. Group 2: Commercial Antibiotic Intracanal Dressing (Commercial-TAP) Participants will receive an intracanal dressing prepared from commercially available tablet formulations of ciprofloxacin, metronidazole, and cefixime containing pharmaceutical excipients. Tablets are pulverized, mixed in equal proportions (1:1:1), and combined with sterile distilled water to obtain a paste with consistency comparable to the PURE-TAP group. Clinical procedure (applies to both groups) All treatments will be performed by a qualified pediatric dentist/endodontic operator under standardized clinical conditions. The procedure includes local anesthesia, rubber dam isolation, access cavity preparation, removal of necrotic pulp tissue, mechanical instrumentation of root canals using hand files, irrigation with sterile saline, collection of a baseline intracanal microbiological sample using sterile paper points, placement of the allocated intracanal dressing, and temporary restoration with glass ionomer cement. The first visit (approximately 40–50 minutes) involves clinical and radiographic examination, canal preparation, microbiological sampling, and placement of the intracanal dressing. At the second visit after two weeks (approximately 30–40 minutes), the intracanal dressing will be removed and a second microbiological sample collected. The canals will then undergo final irrigation, followed by obturation with zinc oxide–eugenol cement and placement of a definitive coronal restoration. Monitoring of adherence to the intervention protocol Adherence to the intervention will be ensured by using a standardized clinical protocol and procedural checklist completed for each participant. All treatments will be performed by the same operator, and clinical records will document the treatment steps, materials used, and visit completion to ensure consistency across participants
Sponsors
Study design
Eligibility
Inclusion criteria
1. Presence of necrotic primary molar(s) requiring endodontic treatment 2. Clinical and radiographic diagnosis of endodontic infection 3. Cooperative behavior allowing dental treatment (Frankl behavior rating scale) 4. Written informed consent obtained from parent or legal guardian
Exclusion criteria
1. Presence of systemic medical conditions that may affect healing or contraindicate dental treatment 2. Known allergy or hypersensitivity to any of the study antibiotics (ciprofloxacin, metronidazole, or cefixime) 3. Advanced physiological root resorption of the primary molar (greater than one-third of root length) 4. Teeth with poor prognosis for endodontic treatment (e.g. non-restorable crowns, excessive mobility) 5. Uncooperative behavior preventing completion of treatment