Outcome of Complete Pulpotomy in Healthy and Type 2 Diabetic Patients in Permanent Teeth with Irreversible Pulpitis

NCT06586775 | Completed

• 1 other identifier: Keerthana ENDO
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Endodontic research on the effects of DM on pulp tissues is scarce. Diabetic human and animal histological research demonstrated a decreased reparatory response in the pulp, resulting in chronic pulp inflammation and reduced dentin bridge formation. To date, there is no human clinical trial examining the impact of diabetes mellitus on teeth with irreversible pulpitis. As a result of the paucity of data in the literature, there is a clinical dilemma whether to recommend vital pulp therapy techniques or root canal treatment in diabetic patients with irreversible pulpitis. To the best of our knowledge, no prospective study has evaluated the outcome of complete pulpotomy in T2DM patients and healthy controls with irreversible pulpitis. The aim of this preliminary study is to compare and evaluate the success rates of pulpotomy in healthy and type 2 diabetes mellitus patients in mature permanent teeth presenting with clinical symptoms of irreversible pulpitis.

Conditions

Irreversible Pulpitis; Diabetes Mellitus, Type 2; Healthy

Keywords

Pulpotomy; irreversible pulpitis; Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Treatment outcome

  Outcome of complete pulpotomy in healthy and diabetic patients through clinical and radiographic findings.

  6 and 12 month follow-up.

Secondary Outcomes (1)

• 1) Effect of treatment on glycated haemoglobin levels in diabetic patients

  3 months post-treatment

Study Arms (2)

diabetic group

EXPERIMENTAL

complete pulpotomy will be performed in teeth with irreversible pulpitis in diabetic patients.

Procedure: Pulpotomy

Healthy group

ACTIVE COMPARATOR

complete pulpotomy will be performed in teeth with irreversible pulpitis in systemically healthy patients.

Procedure: Pulpotomy

Interventions

Pulpotomy PROCEDURE

complete pulpotomy

Healthy group; diabetic group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: Gender matched healthy control participants to the same gender diabetic individuals will be analyzed.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes mellitus with HbA1c \> 6.5% with no other co-morbidities.
• Age and gender matched healthy patients
• Age between 18 - 70 years.
• Mature permanent teeth with clinical and radiographic signs and symptoms indicative of irreversible pulpitis (PAI score ≤2)
• Tooth showing positive response to pulp sensibility testing.

You may not qualify if:

• Patients with immunocompromised diseases or systematic diseases (other than diabetes mellitus)
• Smokers, pregnant and lactating women
• Teeth with immature roots or retained deciduous tooth.
• Bleeding could not be controlled in ≥8 minutes.
• Tooth with signs and symptoms of apical periodontitis.
• Tooth with probing depth more than 4mm.
• Positive history of antibiotic use in the past 1 month or requiring antibiotic prophylaxis and/or analgesic usage in past 3 days.

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

Dr.keerthana

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Pulpotomy

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Endodontics; Dentistry

Study Officials

• Dr.keerthana G, MDS

  PGIDS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigator and the outcome assessor will be blinded with the participants preoperative characteristics and allocation group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: September 19, 2024
• Study Start: August 1, 2023
• Primary Completion: July 31, 2024
• Study Completion: August 1, 2024
• Last Updated: September 19, 2024

Record last verified: 2023-11

Locations

IN (1)