RecruitingNot ApplicableNCT07163975

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

Success of Complete Pulpotomy and Root Canal Treatment and Quality of Life in Patients With Symptomatic Irreversible Pulpitis With Type 2 Diabetes Mellitus: A Randomized Clinical Trial


Sponsor

Postgraduate Institute of Dental Sciences Rohtak

Enrollment

106 participants

Start Date

May 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study compares two dental procedures — complete pulpotomy (removing only the infected part of the nerve inside a tooth) versus full root canal treatment (removing all of the nerve) — in people with type 2 diabetes who have a tooth with irreversible pulpitis (severe tooth nerve inflammation that cannot heal on its own). **You may be eligible if...** - You have been diagnosed with type 2 diabetes (HbA1c between 6.5% and 8%, or specific glucose test results) - You are 18 to 70 years old - You have a back tooth in the lower jaw with symptoms of severe nerve inflammation but no sign of infection beyond the tooth root - Your BMI is below 30 **You may NOT be eligible if...** - You have immunocompromising conditions or chronic kidney disease - You smoke, are pregnant, or breastfeeding - The affected tooth has an immature root - Bleeding from the tooth pulp cannot be controlled Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREcomplete 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.

PROCEDURERoot 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


Locations(1)

PGIDS Rohtak

Rohtak, Haryana, India

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NCT07163975


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