Efficacy of Erbium: Yttrium Aluminium Garnet and Diode laser in enhancing the tissue regeneration ability and clinical outcome in regenerative endodontics
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 63
- Locations
- 1
- Primary Endpoint
- Resolution of symptoms
Study Overview
Brief Summary
The study is designed to assess the success of revascularization in mature teeth with periradicular lesion and the effect of laser in enhancing the regenerative ability.
The experimental groups are
Group 1: Regenerative endodontic procedure (REP) procedure similar to American Association of Endodontists clinical considerations (2016) for immature teeth
Group 2: Diode Laser
Group 3: Er: YAG laser
A power analysis was established by G*power, version 3.0.1(Franz Faul universitat, Kiel, Germany). A sample size of 51 (17 per group) would yield 90% power to detect significant differences, with assuming the effect size of 0.2, (Eldessoky et al) and significance level at 0.05. Considering 20% attrition rate, total sample size is 51+12= 63 (21 per group)
Group 1 the standard revascularization procedure will be carried out as per the AAE guidelines which includes triple antibiotic paste in first appointment for disinfection followed by revaculrization and pRF placement in second appointment which is after 14 days.
in group 2 and group 3 laser assisted irrigation will be used for disinfection and triple antibiotic paste will not be used. during the revascualrization visit photobiomodulation with the respective laser will be done.
patients will be recalled at 1month, 3 months, 6 months, 12 months and 24 months for clinical assessment of symptoms, pulp sensibility tests, digital radiographic assessmnt. CBCT will be done at 12 month follow up to evaluate the regression of periapical lesion.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 50.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Adult male or female subjects 18–50 years of age with Single rooted mature teeth with single canals with Negative response to pulp sensibility test and Peri apical index (PAI) score-3 or 4.
Exclusion Criteria
- •Teeth with periodontal disease, cracks, and minimal coronal structure, Subjects with systemic disease, Pregnant and lactating females.
Outcomes
Primary Outcomes
Resolution of symptoms
Time Frame: Assessment of symptoms at 1 month, 3 months, 6 months, 12 months and 24 month intervals
Secondary Outcomes
- The resolution of periapical lesion size & positive response to pulp sensibility tests.(Pulp sensibility tests & digital radiographs at 1 month, 3 months, 6 months, 12 months & 24 month intervals. CBCT at 12 month recall visit.)
Investigators
Dr Biji Brigit
Government Dental College and Research Institute