"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."

NCT07825415 | Recruiting

• 1 other identifier: Akankshya Pattnaik
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Moderate Severe Pulpitis; Extremely Deep Caries

Keywords

inflammatory biomarkers

Outcome Measures

Primary Outcomes (1)

• Levels of IL-1beta and IL-6 in extremely deep caries in moderate and severe pulpitis

  12 months

Study Arms (2)

extremely deep caries in moderate pulpitis

EXPERIMENTAL

Procedure: full pulpotomy

extremely deep caries in severe pulpitis

EXPERIMENTAL

Procedure: full pulpotomy

Interventions

full pulpotomy PROCEDURE

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.

extremely deep caries in moderate pulpitis; extremely deep caries in severe pulpitis

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

PGIDS, Rohtak

Rohtak, Haryana, 124001, India

RECRUITING

Study Officials

• Dr. Akankshya Pattnaik

  Postgraduate Institute of Dental sciences, Rohtak 124001

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Akankshya Pattnaik, PG student

CONTACT

8658292111; akankshyapattnaik44@gmail.com

Dr. Jigyasa Duhan, MDS

CONTACT

98962 70449

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2026
• First Posted: September 17, 2026
• Study Start: April 29, 2026
• Primary Completion (Estimated): April 28, 2027
• Study Completion (Estimated): April 28, 2028
• Last Updated: September 17, 2026

Record last verified: 2026-09

Locations

IN (1)