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Development of a simple test kit to detect extent of injury for teeth with deep cavity

Development of Point-of-Care testing kit for detection of Inflammatory Status of Pulp in patients with deep caries - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/07/071724
Enrollment
228
Registered
2024-07-31
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K029- Dental caries, unspecified

Interventions

Intervention1: NIL: NIL

Sponsors

Maulana Azad Institute of Dental Sciences, New delhi
Lead Sponsor
Indian Council of Medical Research India Funding provided under ICMRCAR scheme
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 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).

Exclusion criteria

Exclusion criteria: 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;

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
• Establishment of cut-off values for each inflammatory bio-marker individually & in combination. • Evaluation of the accuracy of clinical diagnosis of pulpitis by quantifiable association with cut-off values of the aforementioned bio-markers.Timepoint: Baseline

Countries

India

Contacts

Public ContactDr Sudha Yadav

Maulana Azad Institute of Dental Sciences, New Delhi

sudhayadav2788@gmail.com8010629600

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026