| CTRI Number |
CTRI/2024/11/076561 [Registered on: 11/11/2024] Trial Registered Prospectively |
| Last Modified On: |
02/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Gingival Cleaning With An Soft And Flexible Dental Bur |
|
Scientific Title of Study
|
A Single Blind, Single center, Pilot clinical study to evaluate the safety and Comparative Evaluation of Conventional Therapy With and Without Use of AURIBUR, a soft dental bur for periodontal pocket curettage in the Treatment of Periodontitis: A Randomised split mouth trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AUR-CLN-20241902-1 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Esha Jaiswal |
| Designation |
Clinic Incharge |
| Affiliation |
Multispeciality Dental Clinic |
| Address |
Multispeciality Dental Clinic, First floor, Khante complex, In front of fruit market, Butibori
Nagpur
MAHARASHTRA
441108
India |
| Phone |
9960268612 |
| Fax |
|
| Email |
jaiswalesha07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Roshan Sakharkar |
| Designation |
CEO |
| Affiliation |
Aur Innovations Private Limited |
| Address |
Aur Innovations Private Limited, Plot no 110, New Subhedar Lay Out, Nagpur
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9975795635 |
| Fax |
|
| Email |
rusakharkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Roshan Sakharkar |
| Designation |
CEO |
| Affiliation |
Aur Innovations Private Limited |
| Address |
Aur Innovations Private Limited, Plot no 110, New Subhedar Lay Out, Nagpur, Maharashtra.
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9975795635 |
| Fax |
|
| Email |
rusakharkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aur Innovations Private Limited, Plot No 110, New Subhedar Lay Out, Nagpur - 440024,Maharashtra. |
|
|
Primary Sponsor
|
| Name |
Aur Innovations Prrivate Limited |
| Address |
Plot no 110, New Subhedar Lay Out, Nagpur 440024, Maharashtra |
| Type of Sponsor |
Other [Medical Device Company] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Multispeciality Dental Clinic |
In Front Of Fruit Market, Butibori 441108, Nagpur |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Madhuri Udhaorao Sakharkar |
Khalatkar hospital |
29, reshimbag, umped road
Nagpur
MAHARASHTRA |
7709271072
drmusakharkar@gmail.com |
| Dr Esha Jaiswal |
Multispeciality Dental Clinic |
First floor, chant complex, Near Fruit Market, Butibori, Nagpur, Maharashtra
Nagpur
MAHARASHTRA |
9960268612
jaiswalesha07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KHALATKAR HOSPITAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Plastic Flexible Dental Bur ( AuriBur ) |
Plastic Flexible Dental Bur ( AuriBur ), is used for cleaning and debridement of periodontal pocket in Periodontitis. |
| Comparator Agent |
Scalling and Root Planning With UltraSonic Scaller |
Scalling and root planning is done with the help of Ultra sonic scalller, In Periodontitis |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Male Or Female
Above 18 Yrs of age
Periodontal lesions with pocket probing depth, PPD more than 5mm
Have at least Two natural teeth excluding third molars.
Provide Informed consent and willingness to cooperate with the study protocol.
|
|
| ExclusionCriteria |
| Details |
Treatment with blood thinner drugs
Diseases such as HIV/AIDS, chronic renal failure, ,bleeding disorder and autoimmune diseases
Patient who require antibiotic prophylaxis before examination or treatment
Patient with some mental disability.
intraoral soft tissue or hard tissue pathosis.
Systemic condition contraindicating periodontal therapy
Healthy gingiva and periodontium,
Patient with psychiatric problems,
Simultaneous participation in any other clinical study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
- Reduced Gingival Inflammation And Swelling.
- Periodontal Pocket Depth reduction.
- evaluation of the safety of newly advanced Flexible Plastic Bur ( AURIBUR ) for periodontal pocket curettage in the Treatment of Periodontitis
- Evaluation and comparison of the Conventional Therapy With and Without Use of AURIBUR, a soft dental bur for periodontal pocket curettage in the Treatment of Periodontitis
|
- At Baseline
- 2 Weeks
- 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
evaluation and comparison of clinical parameters with combined efficacy of Auribur as an adjunct to scaling and root planing
Evaluation of combined efficacy of Auribur, a soft flexible Dental Bur for periodontal pocket curettage, as an adjunct to scaling and root planing on improving the Probing depth (PD), Clinical attachment level (CAL), Plaque Index (PI) and Gingival Index (GI).
|
Three Months |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
19/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [rusakharkar@gmail.com].
- For how long will this data be available start date provided 01-05-2025 and end date provided 01-05-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Periodontitis is the one among the most commonly reported oral disease in the human population. It is a polymicrobial disease, involving destruction of supporting tissues of the teeth which leads to pocket formation, loss of alveolar bone, mobility of teeth, thus eventually causing loss of dentition. This disease in turn affects the quality of life of the people. For decades, open flap debridement is considered the standard treatment protocol for management of chronic periodontitis. Despite its success rate, recurrence of the disease still exists. This is because of the nature of the anaerobic periodontal pathogens which are tissue invading and capable of releasing virulence factors that evades the host immune mechanism.There is a requirement of cost effective quality based treatment for patients who are unwilling to do other Conventional therapy like periodontal flap surgery, etc., for periodontitis in conjunction with patient education, oral hygiene improvement, scaling and root planing, and frequent recall maintenance. This research is required to Evaluate and compare the Conventional Therapy With and Without Use of AURIBUR, a soft dental bur for periodontal pocket curettage in the Treatment of Periodontitis |