NCT07549373

Brief Summary

Methodology Patient with diabetes 2 with informed consent -convenience sampling over a one year period.The tooth isolated with a rubber dam and the correct disinfection procedures will be used. researcher will do the Access preparation Working length -electronic apex locator (Dentsply Propex II) as well as a radiographic approach. After the canals will be obturated using ZOE sealer and gutta percha and post endodontic restoration is done using composite restoration. Patient is kept on follow up for 7days, 15 days, 30 days ,45 days and 60 days Clinical outcome is measure using periapical radiograph (RVG) Pain is measured using visual analog scale to mark the pain intensity. Data will be analysed statistically To enlarge the root canals (ISO size 20 file) A sterile paper point inside the root canal for one minute until the apex of the root canal is reached Using T.E Buffer, samples will be delivered to the School Of Basic Life Sciences, Sharda University. The samples will be subjected to traditional PCR analysis for the detection of Peptostreptococcus spp. in the root canal. Grouping Following instrumentation, 5% NaOCl and 17% EDTA irrigation will be done. Control group (n=15) The final irrigant will be saline Group 1 (n=15) Irrigation using 5% apple cider vinegar done The final irrigant will be saline Group 2 (n=15) Diode laser is used for disinfection in the presence of saline Group 3 (n=15) Gymnema Sylvestre Mother Tincture Q 1000 CH solution is used for disinfection in the presence of saline Group 4 (n=15) Diode laser is used for disinfection in the presence of 5% apple cider vinegar. The final irrigant will be saline Group 5 (n=15) Diode laser is used for disinfection in the presence of Gymnema Sylvestre Mother Tincture Q 1000 CH solution. The final irrigant will be saline After cleaning and shaping, samples will be collected and sent through T.E. Buffer to the School Of Basic Life Sciences, Sharda University. The samples will be subjected to traditional PCR analysis for the detection of Peptostreptococcus spp. in the root canal.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
12mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
May 2026May 2027

First Submitted

Initial submission to the registry

April 1, 2026

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 24, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

8 months

First QC Date

April 1, 2026

Last Update Submit

April 23, 2026

Conditions

Diabete Type 2

Keywords

EndodonticsDiode laserApple cider vinegarGymnema sylvestre

Outcome Measures

Primary Outcomes (2)

  • Visual Analog Scale (VAS)

    A Visual Analog Scale is a validated, subjective, 1-dimensional tool used to measure intensity, most commonly pain. It consists of a 10-cm (100-mm) horizontal or vertical line, with endpoints anchored by extremes, such as "no pain" and "worst imaginable pain," with patients marking their level

    6 months

  • Detection of peptostreptococcus species after the use of intervention

    Absence of peptostreptococcus species on PCR signifies disinfection of canal presence of peptostreptococcus species on PCR signifies irrigating agent is not effective

    one year

Study Arms (6)

Saline

EXPERIMENTAL

Saline is used in the ideal conditions

Other: 940 nm diode laserOther: apple cider vinegarOther: Gymnema SylvestreOther: Saline (NaCl)Other: Diode laser and Gymnema SylvestreOther: Diode laser and apple cider vinegar

940 nm diode laser

EXPERIMENTAL

it is used for disinfecting the canal

Other: 940 nm diode laserOther: apple cider vinegarOther: Gymnema SylvestreOther: Saline (NaCl)Other: Diode laser and Gymnema SylvestreOther: Diode laser and apple cider vinegar

Apple cider vinegar

EXPERIMENTAL

It is used as irrigating agent

Other: 940 nm diode laserOther: apple cider vinegarOther: Gymnema SylvestreOther: Saline (NaCl)Other: Diode laser and Gymnema SylvestreOther: Diode laser and apple cider vinegar

Gymnema sylvestre

EXPERIMENTAL

It is used as irrigating agent

Other: 940 nm diode laserOther: apple cider vinegarOther: Gymnema SylvestreOther: Saline (NaCl)Other: Diode laser and Gymnema SylvestreOther: Diode laser and apple cider vinegar

940 diode laser and Apple cider vinegar

EXPERIMENTAL

For disinfecting the canal

Other: 940 nm diode laserOther: apple cider vinegarOther: Gymnema SylvestreOther: Saline (NaCl)Other: Diode laser and Gymnema SylvestreOther: Diode laser and apple cider vinegar

940 diode laser and Gymnema sylvestre

EXPERIMENTAL

For disinfecting the canal

Other: 940 nm diode laserOther: apple cider vinegarOther: Gymnema SylvestreOther: Saline (NaCl)Other: Diode laser and Gymnema SylvestreOther: Diode laser and apple cider vinegar

Interventions

940 nm diode laserOTHER

laser for irrigation

Also known as: diode laser
940 diode laser and Apple cider vinegar940 diode laser and Gymnema sylvestre940 nm diode laserApple cider vinegarGymnema sylvestreSaline
apple cider vinegarOTHER

5% apple cider vinegar

940 diode laser and Apple cider vinegar940 diode laser and Gymnema sylvestre940 nm diode laserApple cider vinegarGymnema sylvestreSaline
Gymnema SylvestreOTHER

antidiabetic agent

Also known as: gudmar
940 diode laser and Apple cider vinegar940 diode laser and Gymnema sylvestre940 nm diode laserApple cider vinegarGymnema sylvestreSaline
Saline (NaCl)OTHER

saline is used as ideal irrigant

Also known as: saline
940 diode laser and Apple cider vinegar940 diode laser and Gymnema sylvestre940 nm diode laserApple cider vinegarGymnema sylvestreSaline
Diode laser and Gymnema SylvestreOTHER

This is the combination disinfection

Also known as: combination therapy
940 diode laser and Apple cider vinegar940 diode laser and Gymnema sylvestre940 nm diode laserApple cider vinegarGymnema sylvestreSaline
Diode laser and apple cider vinegarOTHER

combination therapy used will enhance the disinfection

940 diode laser and Apple cider vinegar940 diode laser and Gymnema sylvestre940 nm diode laserApple cider vinegarGymnema sylvestreSaline

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Using radiographs, intraoral periapical radiographs (RVG) primary endodontic infection will be selected.
  • Multirooted teeth , root with periapical lesion will be selected
  • Type 2 diabetics between the ages of 25 years and 60 years will be chosen; both male and female patients
  • A fasting blood sugar level of 126 mg/dl and a random blood sugar level of less than 200 mg/dl
  • HbA1c (glycated haemoglobin) ≥ 6.5%

You may not qualify if:

  • Patients with systemic conditions other than type 2 diabetes
  • Women who are pregnant
  • Those patients that have used antibiotics within the previous three months,
  • Those patients that have teeth with developmental defects, calcified canals,
  • Teeth that cannot be isolated with rubber dams,
  • Tortuous canals
  • Roots that are fractured

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr Lakshmi Pandey

Noida, Uttar Pradesh, 201310, India

Location

Related Publications (8)

  • Jambagi N, Kore P, Dhaded NS, Patil SA, Shankar M. Comparison of Antimicrobial Efficacy of Diode Laser, Ultrasonic Activated and Conventional Irrigation with 2.5% NaOCl during RCT: An Interventional Study. J Contemp Dent Pract. 2021 Jun 1;22(6):669-673.

    PMID: 34393125BACKGROUND

  • Sonarkar SS, Singh S, Podar R, Kulkarni G, Purba R. An in vivo comparison of the antibacterial efficacy of photoactivated disinfection, diode laser, and 5% sodium hypochlorite in root canal disinfection. J Conserv Dent. 2018 Mar-Apr;21(2):205-209. doi: 10.4103/JCD.JCD_227_17.

    PMID: 29674826BACKGROUND

  • Mota AC, de Castro RD, de Araujo Oliveira J, de Oliveira Lima E. Antifungal Activity of Apple Cider Vinegar on Candida Species Involved in Denture Stomatitis. J Prosthodont. 2015 Jun;24(4):296-302. doi: 10.1111/jopr.12207. Epub 2014 Sep 14.

    PMID: 25219289BACKGROUND

  • Mirzaei M, Rahmaninan M, Mirzaei M, Nadjarzadeh A, Dehghani Tafti AA. Epidemiology of diabetes mellitus, pre-diabetes, undiagnosed and uncontrolled diabetes in Central Iran: results from Yazd health study. BMC Public Health. 2020 Feb 3;20(1):166. doi: 10.1186/s12889-020-8267-y.

    PMID: 32013917BACKGROUND

  • Korona-Glowniak I, Piatek D, Fornal E, Lukowiak A, Gerasymchuk Y, Kedziora A, Bugla-Ploskonska G, Grywalska E, Bachanek T, Malm A. Patterns of Oral Microbiota in Patients with Apical Periodontitis. J Clin Med. 2021 Jun 19;10(12):2707. doi: 10.3390/jcm10122707.

    PMID: 34205290BACKGROUND

  • Farcas-Berechet CM, Berechet EM, Craitoiu S, Alexandru DO, Gheorghe AG, Gheorghita LM, Diaconu OA, Tuculina MJ, Moraru AI, Iacov-Craitoiu MM. Statistical Study of Dental Changes in Patients Diagnosed with Diabetes Mellitus. Curr Health Sci J. 2019 Apr-Jun;45(2):190-197. doi: 10.12865/CHSJ.45.02.10. Epub 2019 Jun 30.

    PMID: 31624647BACKGROUND

  • Owlia F, Zarezadeh F, Jambarsang S, Kazemipoor M. Comparison of the Response to Pulpal Sensibility Tests in Well-Controlled and Uncontrolled Type II Diabetes Mellitus Patients: A Cross-Sectional Study. Int J Dent. 2022 Sep 13;2022:6197070. doi: 10.1155/2022/6197070. eCollection 2022.

    PMID: 36148044BACKGROUND

  • Nair RR, Nayak M, Prasada LK, Nair AV, Soman D, Krishnan RH. PCR-based detection of three anaerobic bacteria associated with endodontic-periodontic lesions in type-2 diabetic and nondiabetic subjects. J Conserv Dent. 2019 Sep-Oct;22(5):430-435. doi: 10.4103/JCD.JCD_326_19. Epub 2020 Aug 4.

    PMID: 33082657BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Lasers, SemiconductorGurmarin protein, Gymnema sylvestreSodium ChlorideCombined Modality Therapy

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and SuppliesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsTherapeutics

Study Officials

  • Dr Ekta Choudhary, MDS

    School of Dental Sciences , Sharda University

    STUDY DIRECTOR

Central Study Contacts

Lakshmi Pandey, MDS

CONTACT

+917349052235drlakshmipandey024@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

April 1, 2026

First Posted

April 24, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

May 1, 2027

Last Updated

April 29, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

PROTOCOL STRATERGIES, STATISTICAL ANALYSIS

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
one year
Access Criteria
anyone with the link

Locations

IN(1)