Development of a simple test kit to detect extent of injury for teeth with deep cavity
- Conditions
- Health Condition 1: K029- Dental caries, unspecified
- Registration Number
- CTRI/2024/07/071724
- Lead Sponsor
- Maulana Azad Institute of Dental Sciences, New delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Patients presenting with symptomatic irreversible pulpitis (IR) will be selected based on below mentioned inclusion criteria-
Clinical inclusion criteria: Medically healthy patients with an extremely deep carious lesion in a permanent molar tooth. Sign and symptom including one or more of the following: history of continuous moderate or severe pain; either provoked or spontaneous lingering pain initiated by provocation (cold test); tenderness to chewing or percussion
Radioraphic inclusion criteria: Teeth presenting with Extremely deep caries, which is defined as ‘Caries penetrating the entire thickness of the dentine, radiographically detectable when located on an interproximal or occlusal surface. Pulp exposure is unavoidable during operative treatment’; no widening of the periodontal ligament space (PAI # 1).
Clinical exclusion criteria: The exclusion criteria will be absence of a response to pulp sensibility tests; non-restorable teeth; periodontal involvement; presence of sinus tract; presence of any systemic disease, pregnant females; history of intake of NSAIDs or antibiotics within last one week; patients who needed prophylactic antibiotics; no pulp exposure after complete caries removal, inadequate blood volume collection after pulpal exposure.
Radiological exclusion criteria: presence of periapical pathology on radiograph; presence of resorption (external/internal); cracked teeth; immature teeth with an open apex;
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Quantification of key inflammatory bio-markers in pulpal blood, including but not limited to interleukin-6, 8 (IL-6, 8), and tumor necrosis factor-alpha (TNF-a) and Measure their sensitivity, specificity, Positive Predictive Value, Negative Predictive ValueTimepoint: Baseline
- Secondary Outcome Measures
Name Time Method •Establishment of cut-off values for each inflammatory bio-marker individually & in combination. <br/ ><br>•Evaluation of the accuracy of clinical diagnosis of pulpitis by quantifiable association with cut-off values of the aforementioned bio-markers.Timepoint: Baseline