Diabete Type 2NCT07549373
Effect of Diode Laser, Gudmar and Vinegar in Diabetic Patients During Root Canal Treatment
A study testing 940 nm diode laser, apple cider vinegar and Gymnema Sylvestre in people with Diabete Type 2, run by Sharda University at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Diabete Type 2
- What is being tested?
- 940 nm diode laser, apple cider vinegar and Gymnema Sylvestre
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteIndia
- Study dates
- 1 May 2026to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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%
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Dr Lakshmi Pandey
Noida, Uttar Pradesh, 201310
Lakshmi Pandey, 07349052235, drlakshmipandey024@gmail.com
About this study
Official title: 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
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.
Read more
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.
Read the detailed description
Study design and ethical consideration The present study will be a randomized controlled clinical study conducted over the period of one year; the study protocol will be reviewed and approved by the institutional; ethics committee , sharda university. All procedures will be performed in accordance with the ethical standards laid down in the declaration of Helsinki.
Patients diagnosed with type 2 diabetes mellitus will be recruited after obtaining written informed consent. Convenience sampling will be employed due to the clinical nature of the study and availability of eligible patient reporting to the out patient department during the study period. .Randomisation will be done using lottery method Patient selection and sampling method Type 2 diabetic patients fulfilling the inclusion criteria will be selected using a convenience sampling technique over a one year period.
Convenience sampling has been widely used in clinical endodontic trials where strict criteria limit patient availability.
After patient recruitment, the selected tooth will be isolated using the rubber dam to maintain asepsis and prevent salivary contamination, which is critical for accurate microbiological sampling.
Access cavity preparation will be performed using and access opening bur # 2 followed by refinement of the access wall using an endo z carbide bur to ensure straight line access to root canals.
Working length determination The working length was determined using the electronic apex locator (Dentsply propex II) and radiographic verification. The use of an electronic apex locator in conjunction with a radiograph has been shown to improve accuracy and reduce procedural errors.
Canal instrumentation and initial microbiological sampling Root canal enlargement was performed up ISO size 20 file , following standardized instrumentation protocol to ensure uniformity across all groups For predisinfection microbial sampling , a sterile paper point was inserted into the root canal and maintained for 1 min, ensuring it reached the apical 3rd of the canal. This technique has been validated for effective recovery of intracanal microorganisms.
The collected paper points were immediately transferred into strile vials containing TE buffer, which preserve bacterial DNA integrity during transport.
Transport and microbiological analysis All sample were transported to the school of basics life sciences , under sterile conditions The samples were subjected to PCR analysis for the detection of peptostreptococcus species, which are obligate anaerobics commonly associated with persistent endodontic infections and apical periodontitis.
PCR was chosen due to its high sensitivity and specificity in detecting low bacterial loads compared to culture methods
Grouping and Disinfection Protocol Following biochemical preparations, all canals were irrigated using 5% sodium hypochlorite (NaOCI) and 17% EDTA, which are considered the gold standard for organic tissues dissolution and smear layer removal, respectively
Patients were randomly allocated into six groups as follows:
Control Group (n=15) Final irrigation was performed using sterile saline
Group 1 - Apple Cider Vinegar (n=15) Irrigation was performed using 5% apple cider vinegar, followed by final irrigation with sterile saline. Apple Cider Vinegar has demonstrated antimicrobial efficacy due to its acetic acid content Group 2 - Diode Laser (n=15) A 940nm diode laser was used for canal disinfection in the presence of saline. Diode lasers have been shown to penetrate dentinal tubules and reduce anaerobic bacterial load effectively Group 3 - Gymnema Sylvestre (n=15) Disinfection was carried out using the Gymnema Sylvestre mother tincture Q 1000 CH solution in the presence of saline. Gymnema sylvestre exhibits documented antimicrobial and anit-infalamatory properties
Group 4 - Diode Laser + Apple Cider Vinegar (n=15) Disinfection was performed using a 940 nm diode laser in the presence of 5% apple cider vinegar followed by saline irrigation
Group 5 - Diode laser + Gymenam Sylvestre (n=15) Disinfection was performed using a 940 nm diode laser in the presence of Gynema Sylvestre mother tincture followed by saline irrigation.
Post-disinfection Sampling After completion of cleaning and shaping and final disinfection protocols, post-treatment microbial samples were collected using sterile paper points and transported in T.E buffer for PCR analysis to assess bacterial reduction.
Follow-up and Outcome Assessment Patients were recalled at 7, 15, 30, 45, 60 days for follow-up Clinical outcome was measured using RVG and PAI was calculated Post-operative pain was assessed using a VAS, a validated toll for pain assessment in endodontics studies Microbiological analysis using traditional polymerase chain reaction (PCR)
- Conditions
- Diabete Type 2
- Being tested
- 940 nm diode laser, apple cider vinegar, Gymnema Sylvestre, Saline (NaCl), Diode laser and Gymnema Sylvestre
- Keywords
- Endodontics, Diode laser, Apple cider vinegar, Gymnema sylvestre
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
940 nm diode laserOther
Also called diode laser
laser for irrigation
apple cider vinegarOther
5% apple cider vinegar
Gymnema SylvestreOther
Also called gudmar
antidiabetic agent
Saline (NaCl)Other
Also called saline
saline is used as ideal irrigant
Diode laser and Gymnema SylvestreOther
Also called combination therapy
This is the combination disinfection
Diode laser and apple cider vinegarOther
combination therapy used will enhance the disinfection
| Study group | Role | What they receive |
|---|---|---|
| Saline | Experimental | Saline is used in the ideal conditions Receives: Other: 940 nm diode laser; Other: apple cider vinegar; Other: Gymnema Sylvestre; Other: Saline (NaCl); Other: Diode laser and Gymnema Sylvestre; Other: Diode laser and apple cider vinegar |
| 940 nm diode laser | Experimental | it is used for disinfecting the canal Receives: Other: 940 nm diode laser; Other: apple cider vinegar; Other: Gymnema Sylvestre; Other: Saline (NaCl); Other: Diode laser and Gymnema Sylvestre; Other: Diode laser and apple cider vinegar |
| Apple cider vinegar | Experimental | It is used as irrigating agent Receives: Other: 940 nm diode laser; Other: apple cider vinegar; Other: Gymnema Sylvestre; Other: Saline (NaCl); Other: Diode laser and Gymnema Sylvestre; Other: Diode laser and apple cider vinegar |
| Gymnema sylvestre | Experimental | It is used as irrigating agent Receives: Other: 940 nm diode laser; Other: apple cider vinegar; Other: Gymnema Sylvestre; Other: Saline (NaCl); Other: Diode laser and Gymnema Sylvestre; Other: Diode laser and apple cider vinegar |
| 940 diode laser and Apple cider vinegar | Experimental | For disinfecting the canal Receives: Other: 940 nm diode laser; Other: apple cider vinegar; Other: Gymnema Sylvestre; Other: Saline (NaCl); Other: Diode laser and Gymnema Sylvestre; Other: Diode laser and apple cider vinegar |
| 940 diode laser and Gymnema sylvestre | Experimental | For disinfecting the canal Receives: Other: 940 nm diode laser; Other: apple cider vinegar; Other: Gymnema Sylvestre; Other: Saline (NaCl); Other: Diode laser and Gymnema Sylvestre; Other: Diode laser and apple cider vinegar |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Diabete Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sharda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Lakshmi Pandey, Sharda University
- Investigators
- Dr Ekta Choudhary, MDS, Study director, School of Dental Sciences , Sharda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07549373
- Sponsor's protocol ID
- ShardaU
- Status last verified
- May 2026
- First submitted
- 1 Apr 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: PROTOCOL STRATERGIES, STATISTICAL ANALYSIS
Publications
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.
PubMed 34393125Sonarkar 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.
PubMed 29674826Mota 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.
PubMed 25219289Mirzaei 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.
PubMed 32013917Korona-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.
PubMed 34205290Farcas-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.
PubMed 31624647Owlia 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.
PubMed 36148044Nair 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.
PubMed 33082657
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07549373
- Acronym / sponsor ID
- ShardaU
- Conditions
- Diabete Type 2
- Keywords
- Endodontics, Diode laser, Apple cider vinegar, Gymnema sylvestre
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sharda UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 24 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study design and ethical consideration The present study will be a randomized controlled clinical study conducted over the period of one year; the study protocol will be reviewed and approved by the institutional; ethics committee , sharda university. All procedures will be performed in accordance with the ethical standards laid down in the declaration of Helsinki.
Patients diagnosed with type 2 diabetes mellitus will be recruited after obtaining written informed consent. Convenience sampling will be employed due to the clinical nature of the study and availability of eligible patient reporting to the out patient department during the study period. .Randomisation will be done using lottery method Patient selection and sampling method Type 2 diabetic patients fulfilling the inclusion criteria will be selected using a convenience sampling technique over a one year period.
Convenience sampling has been widely used in clinical endodontic trials where strict criteria limit patient availability.
After patient recruitment, the selected tooth will be isolated using the rubber dam to maintain asepsis and prevent salivary contamination, which is critical for accurate microbiological sampling.
Access cavity preparation will be performed using and access opening bur # 2 followed by refinement of the access wall using an endo z carbide bur to ensure straight line access to root canals.
Working length determination The working length was determined using the electronic apex locator (Dentsply propex II) and radiographic verification. The use of an electronic apex locator in conjunction with a radiograph has been shown to improve accuracy and reduce procedural errors.
Canal instrumentation and initial microbiological sampling Root canal enlargement was performed up ISO size 20 file , following standardized instrumentation protocol to ensure uniformity across all groups For predisinfection microbial sampling , a sterile paper point was inserted into the root canal and maintained for 1 min, ensuring it reached the apical 3rd of the canal. This technique has been validated for effective recovery of intracanal microorganisms.
The collected paper points were immediately transferred into strile vials containing TE buffer, which preserve bacterial DNA integrity during transport.
Transport and microbiological analysis All sample were transported to the school of basics life sciences , under sterile conditions The samples were subjected to PCR analysis for the detection of peptostreptococcus species, which are obligate anaerobics commonly associated with persistent endodontic infections and apical periodontitis.
PCR was chosen due to its high sensitivity and specificity in detecting low bacterial loads compared to culture methods
Grouping and Disinfection Protocol Following biochemical preparations, all canals were irrigated using 5% sodium hypochlorite (NaOCI) and 17% EDTA, which are considered the gold standard for organic tissues dissolution and smear layer removal, respectively
Patients were randomly allocated into six groups as follows:
Control Group (n=15) Final irrigation was performed using sterile saline
Group 1 - Apple Cider Vinegar (n=15) Irrigation was performed using 5% apple cider vinegar, followed by final irrigation with sterile saline. Apple Cider Vinegar has demonstrated antimicrobial efficacy due to its acetic acid content Group 2 - Diode Laser (n=15) A 940nm diode laser was used for canal disinfection in the presence of saline. Diode lasers have been shown to penetrate dentinal tubules and reduce anaerobic bacterial load effectively Group 3 - Gymnema Sylvestre (n=15) Disinfection was carried out using the Gymnema Sylvestre mother tincture Q 1000 CH solution in the presence of saline. Gymnema sylvestre exhibits documented antimicrobial and anit-infalamatory properties
Group 4 - Diode Laser + Apple Cider Vinegar (n=15) Disinfection was performed using a 940 nm diode laser in the presence of 5% apple cider vinegar followed by saline irrigation
Group 5 - Diode laser + Gymenam Sylvestre (n=15) Disinfection was performed using a 940 nm diode laser in the presence of Gynema Sylvestre mother tincture followed by saline irrigation.
Post-disinfection Sampling After completion of cleaning and shaping and final disinfection protocols, post-treatment microbial samples were collected using sterile paper points and transported in T.E buffer for PCR analysis to assess bacterial reduction.
Follow-up and Outcome Assessment Patients were recalled at 7, 15, 30, 45, 60 days for follow-up Clinical outcome was measured using RVG and PAI was calculated Post-operative pain was assessed using a VAS, a validated toll for pain assessment in endodontics studies Microbiological analysis using traditional polymerase chain reaction (PCR)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Saline | Experimental | Other: 940 nm diode laser, Other: apple cider vinegar, Other: Gymnema Sylvestre, Other: Saline (NaCl), Other: Diode laser and Gymnema Sylvestre, Other: Diode laser and apple cider vinegarSaline is used in the ideal conditions |
| 940 nm diode laser | Experimental | Other: 940 nm diode laser, Other: apple cider vinegar, Other: Gymnema Sylvestre, Other: Saline (NaCl), Other: Diode laser and Gymnema Sylvestre, Other: Diode laser and apple cider vinegarit is used for disinfecting the canal |
| Apple cider vinegar | Experimental | Other: 940 nm diode laser, Other: apple cider vinegar, Other: Gymnema Sylvestre, Other: Saline (NaCl), Other: Diode laser and Gymnema Sylvestre, Other: Diode laser and apple cider vinegarIt is used as irrigating agent |
| Gymnema sylvestre | Experimental | Other: 940 nm diode laser, Other: apple cider vinegar, Other: Gymnema Sylvestre, Other: Saline (NaCl), Other: Diode laser and Gymnema Sylvestre, Other: Diode laser and apple cider vinegarIt is used as irrigating agent |
| 940 diode laser and Apple cider vinegar | Experimental | Other: 940 nm diode laser, Other: apple cider vinegar, Other: Gymnema Sylvestre, Other: Saline (NaCl), Other: Diode laser and Gymnema Sylvestre, Other: Diode laser and apple cider vinegarFor disinfecting the canal |
| 940 diode laser and Gymnema sylvestre | Experimental | Other: 940 nm diode laser, Other: apple cider vinegar, Other: Gymnema Sylvestre, Other: Saline (NaCl), Other: Diode laser and Gymnema Sylvestre, Other: Diode laser and apple cider vinegarFor disinfecting the canal |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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%
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 940 nm diode laserAlso: diode laserlaser for irrigation | Other | 940 diode laser and Apple cider vinegar, 940 diode laser and Gymnema sylvestre, 940 nm diode laser, Apple cider vinegar, Gymnema sylvestre, Saline |
| apple cider vinegar5% apple cider vinegar | Other | 940 diode laser and Apple cider vinegar, 940 diode laser and Gymnema sylvestre, 940 nm diode laser, Apple cider vinegar, Gymnema sylvestre, Saline |
| Gymnema SylvestreAlso: gudmarantidiabetic agent | Other | 940 diode laser and Apple cider vinegar, 940 diode laser and Gymnema sylvestre, 940 nm diode laser, Apple cider vinegar, Gymnema sylvestre, Saline |
| Saline (NaCl)Also: salinesaline is used as ideal irrigant | Other | 940 diode laser and Apple cider vinegar, 940 diode laser and Gymnema sylvestre, 940 nm diode laser, Apple cider vinegar, Gymnema sylvestre, Saline |
| Diode laser and Gymnema SylvestreAlso: combination therapyThis is the combination disinfection | Other | 940 diode laser and Apple cider vinegar, 940 diode laser and Gymnema sylvestre, 940 nm diode laser, Apple cider vinegar, Gymnema sylvestre, Saline |
| Diode laser and apple cider vinegarcombination therapy used will enhance the disinfection | Other | 940 diode laser and Apple cider vinegar, 940 diode laser and Gymnema sylvestre, 940 nm diode laser, Apple cider vinegar, Gymnema sylvestre, Saline |
Primary outcome
Visual Analog Scale (VAS)
Time frame: 6 months
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
Detection of peptostreptococcus species after the use of intervention
Time frame: one year
Absence of peptostreptococcus species on PCR signifies disinfection of canal presence of peptostreptococcus species on PCR signifies irrigating agent is not effective
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Background: PubMed 34393125Jambagi 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.
- Background: PubMed 29674826Sonarkar 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.
- Background: PubMed 25219289Mota 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.
- Background: PubMed 32013917Mirzaei 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.
- Background: PubMed 34205290Korona-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.
- Background: PubMed 31624647Farcas-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.
- Background: PubMed 36148044Owlia 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.
- Background: PubMed 33082657Nair 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.
- Individual participant dataSharing planned: Yes. PROTOCOL STRATERGIES, STATISTICAL ANALYSIS
Related trials for Diabete Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr Ekta Choudhary, MDS study director
School of Dental Sciences , Sharda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 940 nm diode laser, apple cider vinegar and Gymnema Sylvestre in people with Diabete Type 2, run by Sharda University at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lakshmi Pandey, MDS (+917349052235, drlakshmipandey024@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07549373, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.