Actively Recruiting

Phase Not Applicable
Age: 25Years - 60Years
All Genders
ID07549373

Antibacterial Effect of 940nm Diode Laser, Apple Cider Vinegar, and Gymnema Sylvestre in Diabetic Patients with Apical Periodontitis Against Peptostreptococcus Species - A Randomized Clinical Trial

Led by Sharda University · Updated on 2026-05-28

90

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research evaluates the antibacterial effects of different disinfection methods during root canal treatment in patients with type 2 diabetes and apical periodontitis. The study is a randomized controlled clinical trial conducted over one year, aiming to detect Peptostreptococcus species in infected root canals. The trial compares the use of a 940 nm diode laser, apple cider vinegar, Gymnema Sylvestre, and combinations of these against standard saline irrigation in diabetic patients aged 25 to 60 years. Participants undergo standard root canal treatment with aseptic isolation and access cavity preparation. Working length is determined by electronic apex locator and radiography. Canals are instrumented and irrigated using 5% sodium hypochlorite and 17% EDTA. They are then randomly assigned to one of six groups receiving either saline, apple cider vinegar, diode laser, Gymnema Sylvestre solution, or combinations of diode laser with apple cider vinegar or Gymnema Sylvestre. Post-disinfection microbial samples are collected for PCR analysis. Patients are followed up at 7, 15, 30, 45, and 60 days after treatment. Clinical outcomes are assessed using periapical radiographs and the Periapical Index (PAI). Pain intensity is measured by the Visual Analog Scale (VAS). Microbial presence of Peptostreptococcus species is monitored over one year using PCR. The study also tracks pain levels and treatment effects through repeated assessments during the follow-up period.

CONDITIONS

Brief Title

Effect of Diode Laser, Gudmar and Vinegar in Diabetic Patients During Root Canal Treatment

Who Can Participate

Age: 25Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with primary endodontic infection confirmed by intraoral periapical radiographs (RVG)
  • Multirooted teeth with root periapical lesion
  • Type 2 diabetic patients aged 25 to 60 years, both male and female
  • Fasting blood sugar level of 126 mg/dl or higher and random blood sugar less than 200 mg/dl
  • HbA1c (glycated haemoglobin) level of 6.5% or greater
Not Eligible

You will not qualify if you...

  • Patients with systemic conditions other than type 2 diabetes
  • Pregnant women
  • Patients who have used antibiotics within the previous three months
  • Teeth with developmental defects or calcified canals
  • Teeth that cannot be isolated with rubber dams
  • Teeth with tortuous canals
  • Teeth with fractured roots

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single treatment session with immediate post-treatment sampling

Participants undergo root canal treatment with different disinfection protocols including diode laser, apple cider vinegar, Gymnema Sylvestre, or combinations, to reduce bacterial infection in diabetic patients.

1 treatment visit (in-person)

Follow-up

Duration - 60 days post-treatment

Participants are followed up to assess clinical outcomes, pain levels, and bacterial detection through multiple visits.

5 follow-up visits at 7, 15, 30, 45, and 60 days (in-person)

Trial Site Locations

Total: 1 location

1

Dr Lakshmi Pandey

Noida, Uttar Pradesh, India, 201310

Actively Recruiting

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Research Team

L

Lakshmi Pandey, MDS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

6

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