Clinical trial NCT06586775: Outcome of Complete Pulpotomy in Healthy and Type 2 Diabetic Patients in Permanent Teeth with Irreversible Pulpitis
Official title: Outcome of Complete Pulpotomy in Healthy and Type 2 Diabetic Patients in Permanent Teeth with Irreversible Pulpitis - a Preliminary Prospective Interventional Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irreversible Pulpitis
Diabetes Mellitus, Type 2
Healthy
Keywords: Pulpotomy
irreversible pulpitis
Type 2 Diabetes
Lead sponsor: Postgraduate Institute of Dental Sciences Rohtak
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Introduction:

Endodontic disease can affect both the pulp and the periapical areas of the tooth. The resultant immune-pathological reaction could be acute or chronic inflammation, depending on the ability of pulp and periapical tissue to respond to and recover from the noxious stimuli. T2DM has been recognized as a crucial factor affecting the pulpal and periapical tissues, in terms of susceptibility, progression, and healing. 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.

AIM The aim of this study is to evaluate and compare the outcome of complete pulpotomy in healthy and type 2 diabetes mellitus patients presenting with clinical and radiographic signs and symptoms indicative of irreversible pulpitis.

OBJECTIVES

* To evaluate the clinical and radiographic success of pulpotomy with clinical and radiographic signs indicative of irreversible pulpitis.
* To investigate the effect of treatment outcome on glycated hemoglobin (HbA1c) in type 2 diabetic patients with irreversible pulpitis.

RESEARCH QUESTION Does the complete pulpotomy in type 2 diabetes mellitus patients is as effective as complete pulpotomy in healthy patients in mature permanent teeth presenting with clinical and radiographic signs and symptoms indicative of irreversible pulpitis? PICO

* P (Population) - Diabetic patients with mature permanent teeth with clinical and radiographic signs of irreversible pulpitis
* I (Intervention) - Complete pulpotomy in diabetic patients
* C (Comparison) - Complete pulpotomy in healthy patients
* O (Outcome) - Assessment of clinical and radiographic success at 3, 6 and 12 months follow-up.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Treatment outcome
timeFrame: 6 and 12 month follow-up.
Secondary outcomes:
measure: 1) Effect of treatment on glycated haemoglobin levels in diabetic patients
timeFrame: 3 months post-treatment
Other outcomes:
Locations:
city: Rohtak
country: India
facility: Dr.keerthana
state: Haryana
Study officials:
affiliation: PGIDS
name: Dr.keerthana G, MDS
role: PRINCIPAL_INVESTIGATOR
References: