Clinical trial

The Efficacy of 2780 nm Er,Cr;YSGG and 940 nm Diode Laser in Root Canal Disinfection: A Randomized Clinical Trial

Name
FDASU-Rec ID 041908
Description
The aim of this study is to assess in vivo the efficacy of Er,Cr:YSGG/diode laser and Diode/EDTA on bacterial count in root canal treatment in an evidence-based clinical trial. The null hypothesis being tested is that there is no difference in total bacterial count reduction between conventional irrigation and the two types of lasers used. Thirty patients are equally divided into 3 separate groups : * Group A (Conventional): 2.5% NaOCL and 17% EDTA. * Group B(Dual): saline along with Er,Cr:YSGG laser and diode laser combination * Group C(Combined): saline along with 17% EDTA and diode laser combination Microbiological analysis will be done for both aerobic and anaerobic bacteria using Colony forming units. All data will be collected, tabulated, summarized, and statistically analyzed.
Trial arms
Trial start
2022-01-01
Estimated PCD
2022-09-30
Trial end
2022-12-30
Status
Completed
Phase
Early phase I
Treatment
Conventional group (NaOCl/EDTA)
conventional disinfection using 2.5% sodium hypochlorite and 17% EDTA
Arms:
Conventional group A
Dual laser group (Er,Cr:YSGG/Diode):
Er,Cr:YSGG intracanal laser irradiation to remove smear layer followed by diode laser for disinfection
Arms:
Dual laser group B
Combined group (EDTA/Diode):
17% EDTA was used to remove smear layer followed by diode laser for disinfection
Arms:
Combined group C
Size
30
Primary endpoint
Quantitative microbiological analysis
baseline (S1): sample will be obtained before canal disinfection. post operative (S2): sample will be obtained after canal disinfection in a single visit]
Eligibility criteria
Inclusion Criteria: * • Patients who are medically free. * Patient's age between 18-35 years. * One single rooted maxillary anterior tooth with necrotic pulp and asymptomatic apical periodontitis requiring root canal treatment. * Patients complaining of no pain and without fistulous tract. * Periapical lesion with a periapical index score of 3 or 4 (Ørstavik, et al. (1986)108 * Closed apex. * Acceptance to participate in the study. Exclusion Criteria: * Patients suffering from any systemic disease. * Patients who had received antibiotics during the last month. * Patients taking analgesics 12 hours before interventions. * Patients with history of tobacco usage * Teeth with vital pulp, calcified canals, and immature or incompletely formed apices. * Teeth with previous endodontic treatment. * Non restorable teeth where rubber dam could not be applied. * Teeth with periodontal pocket more than 3 mm. * Teeth with greater than grade 1 mobility. * Teeth with swelling/sinus tract. * Technical difficulties in the course of root canal treatment for example: * A tooth with curved roots
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 30, 'type': 'ACTUAL'}}
Updated at
2023-11-29

1 organization

3 products

3 indications

Indication
Pulp Necroses
Indication
Granuloma