Complete Pulpotomy and Root Canal Treatment Patients With Irreversible Pulpitis With Type 2 Diabetes Mellitus

NCT07163975 | Recruiting

• 1 other identifier: Anmol Jain
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

there is limited endodontic research on the effects of DM on pulp tissues. Diabetic human and animal histological research have demonstrated decreased wound repair, chronic pulp inflammation and reduced dentin bridge formation. To date, no human clinical trial has examined the impact of diabetes mellitus on teeth with irreversible pulpitis. Due to the paucity of data in the literature, there is a clinical dilemma whether to recommend root canal therapy or vital pulp therapy in diabetic patients with irreversible pulpitis. To the best of our knowledge, no prospective study has evaluated the outcome of complete pulpotomy versus root canal treatment in T2DM patients with irreversible pulpitis. The aim of this study is to compare and evaluate the success rates of pulpotomy and root canal treatment in type 2 diabetes mellitus patients in mature permanent teeth presenting with clinical symptoms of irreversible pulpitis.

Conditions

Type 2 Diabetes Mellitus (T2DM); Irreversible Pulpitis

Keywords

pulpotomy; type 2 Diabetes Mellitus; irreversible pulpitis

Outcome Measures

Primary Outcomes (2)

• clinical success

  Clinical success criteria No history of spontaneous pain or discomfort except for the initial days after treatment. No tenderness to palpation or percussion and the tooth is functional. Normal mobility and probing pocket depth. Soft tissues around tooth are normal with no swelling or sinus tract.

  12 months

• radiographic success

  Radiographic success criteria No pathosis evident on the radiograph such as root resorption, furcal pathosis or new periapical pathosis. Periapical Index score 1 or 2

  12 months

Secondary Outcomes (1)

• quality of life assessment

  12 months

Study Arms (2)

complete pulpotomy

EXPERIMENTAL

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

Procedure: complete pulpotomy

Root Canal Treatment

ACTIVE COMPARATOR

root canal treatment will be performed in teeth with irreversible pulpitis in diabetic patients.

Procedure: Root canal treatment

Interventions

complete pulpotomy PROCEDURE

the exposed pulp tissue will be amputated using fresh sterile large round diamond bur in a high-speed hand-piece under water coolant to the level of canal orifices. The pulp wound will be irrigated with 3% NaOCl. For hemostasis, sterile cotton soaked in 3% NaOCl will be placed over the pulpal wound for 2 minutes, repeated for up to 5 min if required. Root canal therapy will be initiated in cases in which haemostasis is not achieved within 5 minutes. After hemostasis, MTA will be placed in thickness of 2 to 3 mm over the pulp exposure site using a carrier. This will be followed by application of a layer of light-cure RMGIC and light-curing for 20 sec. The tooth then will be restored using composite resin following etch and rinse technique.

complete pulpotomy

Root canal treatment PROCEDURE

RCT will be performed in single visit. Root canal orifices will be explored using a DG 16 probe. A size 10 or 15 K-file will be passively inserted into the coronal two- thirds of the canal to verify a smooth glide path. Coronal enlargement will be done using Gates-Glidden drills. Working length will be determined with the help of electronic apex locator and will be confirmed radiographically. Canals will be prepared using the crown down technique with NiTi rotary instruments. The master apical file (MAF) size for each canal will be selected to be three sizes larger than the initial apical binding file at the WL. 5ml of 5.25% sodium hypochlorite using a 30-gauge side-vented needle will be used for optimal irrigation after each instrument. After completion of canal instrumentation, the canals will be irrigated with 5.0 ml of 17% ethylene-diamine-tetra acetic acid for 1 minute followed by a final irrigation with 5.0 ml of 5.25% sodium hypochlorite. Canals will be dried with

Root Canal Treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes mellitus defined by HbA1c levels 6.5% - 8% OR FPG ≥126 mg/dL OR 2-hour plasma glucose ≥200 mg/dL during an OGTT OR A random plasma glucose of 200 mg/dL or higher in a patient with classic symptoms of hyperglycemia or hyperglycemic crisis
• Age between 18 - 70 years.
• Permanent mandibular posterior teeth with clinical and radiographic signs and symptoms indicative of irreversible pulpitis (PAI score ≤2)
• Tooth showing positive response to pulp sensibility testing with no tenderness on percussion.
• BMI\<30 Kg/m2

You may not qualify if:

• Patients with immunocompromised diseases or chronic kidney disease
• Smokers, pregnant and lactating women
• Teeth with immature roots or retained deciduous tooth.
• Bleeding could not be controlled in ≥5 minutes.
• Tooth with signs and symptoms of apical periodontitis.
• Teeth with procedural errors, cracks, fractured teeth
• 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.
• Patients taking drugs that affect bone metabolism such as immune- suppressants, SSRIs, bisphosphonates, hormone replacement therapy

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

PGIDS Rohtak

Rohtak, Haryana, 124001, India

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Officials

• Jigyasa Duhan, MDS

  PGIDS Rohtak

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jigyasa Duhan, MDS

CONTACT

+91 9896270449; prashitiduhan@rediffmail.com

Anmol Jain

CONTACT

+91 9599724799; drjain.anmol@gmail.com

Study Design

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

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: September 9, 2025
• Study Start: May 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: September 9, 2025

Record last verified: 2025-04

Locations

IN (1)