"The Relationship Between Pulpal Inflammatory Marker Levels in Moderate and Severe Pulpitis and Outcome of Full Pulpotomy in Mandibular Molars With Extremely Deep Caries: A Prospective Cohort Study."

Study Title: - The Relationship between pulpal inflammatory marker levels in moderate and severe pulpitis and outcome of full pulpotomy in mandibular molars with extremely deep caries: A prospective cohort study." RATIONALE: - Dental caries-induced pulpal inflammation represents a dynamic biological process in which the intensity of the host immune response increases with lesion depth. Extremely deep caries can be present clinically as moderate or severe pulpitis where the pulp inflammation is extensive and confine in the crown or possibly extend itself into the root canals respectively. Clinical diagnostic methods used to identify this stage are largely subjective and often fail to reflect the true biological status of the pulp, leading to inconsistent treatment outcomes.

Aim & Objectives- To assess and compare the levels of IL-1Beta and IL-6 in extremely deep caries in moderate and severe pulpitis and to correlate these levels with treatment outcomes of full pulpotomy. Setting: - Study will be conducted in Post Graduate Institute of Dental Sciences, Rohtak in department of Conservative Dentistry & Endodontics. Study Design: - Prospective cohort study Time Frame: - 12-18 months Participants: -Inclusion criteria:- o Medically healthy patients (ASA 1). o Age 18-40 years o Patients with extremely deep caries in permanent mandibular molars. o Extremely deep caries, that is penetrating the entire thickness of the dentine without a radiopaque zone separating the lesion from the pulp o PAI score less then or equal to 2 o Pulpal diagnosis via clinical and radiographic examination as well as thermal, electric pulp testing, categorized as moderate pulpitis (Heightened and prolonged reaction to cold, which can last for minutes Possible percussion sensitive Stimulated or spontaneous lingering pain that can be suppressed with analgesics. No sleep disturbance) or severe pulpitis (Severe spontaneous pain Clear lingering pain reaction to cold and warms stimuli Sleeping disturbance and lingering pain Possible sensitive to percussion Extremely deep caries mostly). Exclusion criteria • Primary teeth • Traumatic or mechanical exposure • No pulp exposure after caries excavation. • Haemostasias not achieved within 10 minutes. • Presence of periapical lesion or evidence of internal or external resorption, calcified canals, as assessed by radiographic examination. • Patients with periodontal disease, swelling and sinus tract. • Immunocompromised or pregnant patients, patients with any systemic disease, and a positive history of antibiotic and analgesic use within week before the treatment. Sample size: -86 (43per group) Outcome variables: Primary outcome: Levels of IL-1beta and IL-6 in extremely deep caries in moderate and severe pulpitis Secondary outcome: To assess the correlation between the marker levels and clinical and radiographic success of full pulpotomy at 6 and 12 months interval. Statistical method: - The normality of the data will be checked by Shapiro-Wilks test in SPSS software. If the data will be non-normal, then non-parametric tests will be applied. Intergroup and intra group comparison will be done according to distribution of data. Categorical data will be analysed using chi-square test. Regression analysis will be done to observe any association between dependent and independent variable. The Spearman rank correlation test will be used to measure the strength of association between concentration of IL-6 ,IL-1Beta in pulpal blood samples.

Study Overview

• Status: Recruiting
• Conditions: Extremely Deep Caries; Moderate Severe Pulpitis
• Intervention / Treatment: Procedure: full pulpotomy

Detailed Description

Study Title: - The Relationship between pulpal inflammatory marker levels in moderate and severe pulpitis and outcome of full pulpotomy in mandibular molars with extremely deep caries: A prospective cohort study." RATIONALE: - Dental caries-induced pulpal inflammation represents a dynamic biological process in which the intensity of the host immune response increases with lesion depth. Extremely deep caries can be present clinically as moderate or severe pulpitis where the pulp inflammation is extensive and confine in the crown or possibly extend itself into the root canals respectively. Clinical diagnostic methods used to identify this stage are largely subjective and often fail to reflect the true biological status of the pulp, leading to inconsistent treatment outcomes. Inflammatory cytokines play a pivotal role in the initiation and progression of pulpal inflammation. Among these, Interleukin-6 (IL-6) and Interleukin-1 beta (IL-1β) are key pro-inflammatory mediators involved in the regulation of immune cell recruitment, vascular changes, and tissue destruction within the dental pulp. IL-1β is an early-phase cytokine that promotes leukocyte infiltration, matrix degradation, and amplification of the inflammatory cascade, while IL-6 is associated with sustained inflammation and reflects the severity and progression of pulpal injury. Moderate and severe pulpitis differ in terms of bacterial penetration, dentin thickness, and pulpal inflammation. Assessing the expression of these biomarkers may provide objective evidence of inflammatory burden and help distinguish subtle biological differences not apparent through conventional diagnostic tests. Quantification of IL-6 and IL-1β levels in pulpal blood using enzyme-linked immunosorbent assay (ELISA) may therefore serve as a reliable and minimally invasive method to evaluate pulpal inflammatory status. This approach has the potential to enhance diagnostic accuracy, support evidence-based decision-making for vital pulp therapy, and contribute to the development of biologically driven treatment protocols. Hence, this study aims to evaluate and compare IL-6 and IL-1β levels in moderate and severe pulpitis with extremely deep carious lesion , thereby providing insight into pulpal inflammatory dynamics and their clinical relevance in assessing treatment outcome. Aim & Objectives- To assess and compare the levels of IL-1Beta and IL-6 in extremely deep caries in moderate and severe pulpitis and to correlate these levels with treatment outcomes of full pulpotomy. Setting: - Study will be conducted in Post Graduate Institute of Dental Sciences, Rohtak in department of Conservative Dentistry & Endodontics. Study Design: - Prospective cohort study Time Frame: - 12-18 months Participants: - Inclusion criteria:- o Medically healthy patients (ASA 1). o Age 18-40 years o Patients with extremely deep caries in permanent mandibular molars. o Extremely deep caries, that is penetrating the entire thickness of the dentine without a radiopaque zone separating the lesion from the pulp o PAI score less then or equal to 2 o Pulpal diagnosis via clinical and radiographic examination as well as thermal, electric pulp testing, categorized as moderate pulpitis (Heightened and prolonged reaction to cold, which can last for minutes Possible percussion sensitive Stimulated or spontaneous lingering pain that can be suppressed with analgesics. No sleep disturbance) or severe pulpitis (Severe spontaneous pain Clear lingering pain reaction to cold and warms stimuli Sleeping disturbance and lingering pain Possible sensitive to percussion Extremely deep caries mostly). Exclusion criteria • Primary teeth • Traumatic or mechanical exposure • No pulp exposure after caries excavation. • Haemostasias not achieved within 10 minutes. • Presence of periapical lesion or evidence of internal or external resorption, calcified canals, as assessed by radiographic examination. • Patients with periodontal disease, swelling and sinus tract. • Immunocompromised or pregnant patients, patients with any systemic disease, and a positive history of antibiotic and analgesic use within week before the treatment. Sample size: -86 (43per group) Sample size was calculated based on the result of previous study done by Carredu and Duncan(2021)(21) where the success of partial pulpotomy in moderate and severe pulpitis were 88 and 60 percent respectively, given that no significant difference in results were seen in partial and full pulpotomy in studies conducted by Ramani et al (2022) and Jassal et al(2022). . With 5% α and 90% power, the minimum required sample size was 38 per group. Considering 10% attrition the effective sample size is calculated to be 43 for each group. Methods: - After removal of Caries in accordance with the standard protocol complete de- roofing of the pulp chamber will be carried out and pulp tissue will be removed to the root canal orifices. A standard volume of 100 μL of pulpal blood sample will be collected using a single channel micropipette. Haemostasis will be achieved using 3% sodium hypochlorite. MTA will be used as a pulp capping material followed by restoration with composite. The quantification of molecular markers will be done using ELISA. Outcome variables: Primary outcome: Levels of IL-1beta and IL-6 in extremely deep caries in moderate and severe pulpitis Secondary outcome: To assess the correlation between the marker levels and clinical and radiographic success of full pulpotomy at 6 and 12 months interval. Statistical method: - The normality of the data will be checked by Shapiro-Wilks test in SPSS software. If the data will be non-normal, then non-parametric tests will be applied. Intergroup and intra group comparison will be done according to distribution of data. Categorical data will be analysed using chi-square test. Regression analysis will be done to observe any association between dependent and independent variable. The Spearman rank correlation test will be used to measure the strength of association between concentration of IL-6 ,IL-1Beta in pulpal blood samples

• Study Type: Interventional
• Enrollment (Estimated): 86
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr. Akankshya Pattnaik, PG student; Phone Number: 8658292111; Email: akankshyapattnaik44@gmail.com
• Study Contact Backup: Name: Dr. Jigyasa Duhan, MDS; Phone Number: 98962 70449

Study Locations

• India
  • Haryana
    • Rohtak, Haryana, India, 124001
      • Recruiting
      • PGIDS, Rohtak

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• o Medically healthy patients (ASA 1).

  • Age 18-40 years
  • Patients with extremely deep caries in permanent mandibular molars.
  • Extremely deep caries, that is penetrating the entire thickness of the dentine without a radiopaque zone separating the lesion from the pulp
  • PAI score less then or equal to 2
  • Pulpal diagnosis via clinical and radiographic examination as well as thermal, electric pulp testing, categorized as moderate pulpitis (Heightened and prolonged reaction to cold, which can last for minutes Possible percussion sensitive Stimulated or spontaneous lingering pain that can be suppressed with analgesics. No sleep disturbance) or severe pulpitis (Severe spontaneous pain Clear lingering pain reaction to cold and warms stimuli Sleeping disturbance and lingering pain Possible sensitive to percussion Extremely deep caries mostly).

Exclusion Criteria:

• • Primary teeth

  • Traumatic or mechanical exposure
  • No pulp exposure after caries excavation.
  • Haemostasias not achieved within 10 minutes.
  • Presence of periapical lesion or evidence of internal or external resorption, calcified canals, as assessed by radiographic examination.
  • Patients with periodontal disease, swelling and sinus tract.
  • Immunocompromised or pregnant patients, patients with any systemic disease, and a positive history of antibiotic and analgesic use within week before the treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: extremely deep caries in moderate pulpitis	Procedure: full pulpotomy; After removal of Caries in accordance with the standard protocol complete de- roofing of the pulp chamber will be carried out and pulp tissue will be removed to the root canal orifices. A standard volume of 100 μL of pulpal blood sample will be collected using a single channel micropipette. Haemostasis will be achieved using 3% sodium hypochlorite. MTA will be used as a pulp capping material followed by restoration with composite. The quantification of molecular markers will be done using ELISA.
Experimental: extremely deep caries in severe pulpitis	Procedure: full pulpotomy; After removal of Caries in accordance with the standard protocol complete de- roofing of the pulp chamber will be carried out and pulp tissue will be removed to the root canal orifices. A standard volume of 100 μL of pulpal blood sample will be collected using a single channel micropipette. Haemostasis will be achieved using 3% sodium hypochlorite. MTA will be used as a pulp capping material followed by restoration with composite. The quantification of molecular markers will be done using ELISA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Levels of IL-1beta and IL-6 in extremely deep caries in moderate and severe pulpitis	12 months

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Dental Sciences Rohtak
• Investigators: Principal Investigator: Dr. Akankshya Pattnaik, Postgraduate Institute of Dental sciences, Rohtak 124001

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2026
• Primary Completion (Estimated): April 28, 2027
• Study Completion (Estimated): April 28, 2028

Study Registration Dates

• First Submitted: September 13, 2026
• First Submitted That Met QC Criteria: September 13, 2026
• First Posted (Actual): September 17, 2026

Study Record Updates

• Last Update Posted (Actual): September 17, 2026
• Last Update Submitted That Met QC Criteria: September 13, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: inflammatory biomarkers
• Other Study ID Numbers: Akankshya Pattnaik

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No