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

NCT ID: NCT07163975

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2027-05-01

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.

Detailed Description

Rationale: - Preservation of pulp vitality is a critical factor in long-term tooth survival. In extremely deep carious lesion with symptomatic irreversible pulpitis, vital pulp therapy procedures in the form of complete pulpotomy is a more conservative treatment strategy, based on the premise that a biologically active material placed in direct contact with the pulp wound can determine the pulpal response and result in the development of a reparative hard tissue bridge to preserve pulp vitality. Scientific literature indicates that type 2 diabetes mellitus has a detrimental effect on the wound healing capacity of dental pulp, however lacks evidence in clinical studies. to the best of our knowledge no study has been done till date comparing the outcome of complete pulpotomy and root canal treatment in patients with type 2 diabetes mellitus with clinical signs of irreversible pulpitis.

Aim- To compare the outcome of complete pulpotomy and root canal treatment in mandibular permanent posterior teeth with clinical signs indicative of irreversible pulpitis in patients with type 2 diabetes mellitus

Objectives-

1. To evaluate the clinical and radiographic success of complete pulpotomy in type 2 diabetic patients in permanent mandibular posterior teeth with clinical signs indicative of irreversible pulpitis.

2. To evaluate the clinical and radiographic success of root canal treatment in type 2 diabetic patients mandibular permanent posterior teeth with clinical signs indicative of irreversible pulpitis.

Population - Permanent mandibular posterior teeth with diagnosis of symptomatic irreversible pulpitis in patients with Type 2 Diabetes Mellitus.

Intervention/Treatment- complete pulpotomy

Comparator- Root canal treatment

Outcome- success of complete pulpotomy versus root canal treatment based on clinical and radiographic findings at 3, 6 and 12 months secondary outcome: assessment of quality of life 1 week, 6 and 12 months post treatment.

Time frame - 1 year

Conditions

Type 2 Diabetes Mellitus (T2DM); Irreversible Pulpitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

complete pulpotomy

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

Group Type: EXPERIMENTAL

complete pulpotomy

Intervention Type: 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.

Root Canal Treatment

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

Group Type: ACTIVE_COMPARATOR

Root canal treatment

Intervention Type: 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

Interventions

complete pulpotomy

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.

Intervention Type: PROCEDURE

Root canal treatment

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Postgraduate Institute of Dental Sciences Rohtak

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jigyasa Duhan, MDS

Role: PRINCIPAL_INVESTIGATOR

PGIDS Rohtak

Locations

PGIDS Rohtak

Rohtak, Haryana, India

Site Status: RECRUITING

Countries

India

Central Contacts

Jigyasa Duhan, MDS

Role: CONTACT

prashitiduhan@rediffmail.com

+91 9896270449

Anmol Jain

Role: CONTACT

drjain.anmol@gmail.com

+91 9599724799

Facility Contacts

Jigyasa Duhan, MDS

Role: primary

prashitiduhan@rediffmail.com

+91 9896270449

Anmol Jain

Role: backup

drjain.anmol@gmail.com

+91 9599724799

Other Identifiers

Anmol Jain

Identifier Type: -

Identifier Source: org_study_id