Comparison of Surgical Extrusion vs. Fibre Post Restoration for Crown-root Fractured Maxillary Incisors.
NCT04685161 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140
Last updated 2021-03-30
Summary
A total of 124 samples was calculated to be sufficient with G\*power software ver 3.1.9.2 with effect size of 0.4 alpha probability error and power 0.95.With drop out estimate of 10% the final sample size decided was 140 samples. Patients reporting with complicated(pulp exposed or pulpally involved) horizontal crown root fracture with loss of crown structure in maxillary incisors and radiograph evidence of supra alveolar tooth structure are recruited for study. Informed consent from the patients or guardian as appropriate is obtained as suitable prior to treatment delivery. Exclusion criteria were:patients not willing for recall visits, root with evidence of cervical resorption or roor canal filling, open apices, patient with systemic ailments rendering root canal treatment, compromised periodontal health, vertical or horizontal root fracture. Pulpal condition of tooth was assessed using cold sensibility test(Neosnow, orikam health care Ltd, India.) amd confirmed upon access opening with teeth showing evidence of pulpal bleeding wad categorized as irreversible pulpitis and teeth with no evidence of pulpal bleeding categorized as necrotic pulp.
Conditions
- Fractured Tooth
Interventions
- PROCEDURE
-
Surgical extrusion
Invasive treatment option for fractured tooth
- DEVICE
-
Fibre post
Easy approach for treatment
Sponsors & Collaborators
-
Tamil Nadu Dr.M.G.R.Medical University
lead OTHER
Principal Investigators
-
ANAND SHERWOOD, MDS · TNMGRMU
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 15 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-01-15
- Primary Completion
- 2022-05-31
- Completion
- 2023-05-31
Countries
- India
Study Locations
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