| CTRI Number |
CTRI/2024/10/075708 [Registered on: 23/10/2024] Trial Registered Prospectively |
| Last Modified On: |
18/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
EFFICIANCY OF COVENTIONAL BURS, SMART BURS AND BRIX 3000 IN CARIES REMOVAL |
|
Scientific Title of Study
|
COMPARATIVE EVALUATION OF THE EFFICACY OF BRIX3000, SMART BURS, AND CONVENTIONAL METHOD IN CARIES EXCAVATION. |
| Trial Acronym |
caries removal |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akanksha shah |
| Designation |
2nd yr post graduate student |
| Affiliation |
H.K.E. SOCIETY’S S. NIJALINGAPPA INSTITUTE OF DENTAL SCIENCES AND RESEARCH, KALABURAGI- 585105. |
| Address |
Arihant Building 8th cross, Vitthal nagar, Kalaburagi.
Gulbarga
KARNATAKA
585103
India |
| Phone |
8951888201 |
| Fax |
|
| Email |
akankshashah1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Supriya Patil |
| Designation |
Reader |
| Affiliation |
H.K.E. SOCIETY’S S. NIJALINGAPPA INSTITUTE OF DENTAL SCIENCES AND RESEARCH, KALABURAGI- 585105. |
| Address |
Patil building, Khuba Plot, Brahampur, Kalaburagi, Karnataka 585105
Gulbarga
KARNATAKA
585105
India |
| Phone |
8951888201 |
| Fax |
|
| Email |
akankshashah1997@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Akanksha shah |
| Designation |
2nd yr post graduate student |
| Affiliation |
H.K.E. SOCIETY’S S. NIJALINGAPPA INSTITUTE OF DENTAL SCIENCES AND RESEARCH, KALABURAGI- 585105. |
| Address |
Arihant building, 8th cross, Vitthal nagar, Kalaburagi.
Gulbarga
KARNATAKA
585103
India |
| Phone |
8951888201 |
| Fax |
|
| Email |
akankshashah1997@gmail.com |
|
|
Source of Monetary or Material Support
|
| HKES, s S NIJALINGAPPA COLLEGE OF DENTAL SCIENCE AND RESEARCH INSTITUTE, KALABURGI - 585105, INDIA |
|
|
Primary Sponsor
|
| Name |
Akanksha shah |
| Address |
Arihant Building, 8th cross, Vitthal nagar, Kalaburagi. |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| ANUPAM |
SUDESHNAVIHAR APTS BEHIND GANDHI TVS SHOWROOM, RAILWAY LINES SOLAPUR - 413001 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR AKANKSHA SHAH |
H.K.E. SOCIETY’S S. NIJALINGAPPA INSTITUTE OF DENTAL SCIENCES AND RESEARCH, KALABURAGI- 585105. |
Department No:4,
Department of Conservative Dentistry and Endodontics
Gulbarga
KARNATAKA |
8951888201
akankshashah1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| S. Nijalingappa Institute of Dental Sciences and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
patient with class 1 dental caries on molars (caries which are only involving enamel and dentin on occlusal surface) |
| Patients |
(1) ICD-10 Condition: K025||Dental caries on pit and fissure surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BRIX3000
POLYMER BURS |
BRIX3000 - is a papain-based chemo mechanical agent, with a proteolytic enzyme and works on the bio encapsulation technology
POLYMER BURS - They are paddle shaped burs and have a unique flute design
The cutting edges will go blunt when in contact with harder materials, such as healthy dentin. |
| Comparator Agent |
ROUND BUR |
no 2- 4 small round bur along with normal aerotar |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Wide Class 1 deep carious lesion on permanent molars
2.No pulpal involvement as evident on a radiograph
3.Good oral hygiene
4.Patient willing for voluntary participation and have signed the informed consent
|
|
| ExclusionCriteria |
| Details |
1.Pulpal exposure or bleeding during the excavation procedure
2.Patients with underlying systemic diseases.
3.Teeth with any developmental anomalies
4.Teeth with any previous restorations
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Colony forming unit will be checked to determine the efficacy of caries removal of these products |
1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Shapiro Wilk test will be used to check which all variables will follow normal distribution
colony forming units will be calculated to determine the most efficient method |
24-48hrs incubation will be done prior to calculation of colony forming unit |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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
|
N/A |
|
Date of First Enrollment (India)
|
11/11/2024 |
| 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="6"
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 - NO
|
|
Brief Summary
|
In this era of “Minimal Invasive Dentistry†preserving tooth structure, is increasingly becoming a standard in dental practice. Conventional caries removal and cavity preparation entails the use of high-speed handpiece and burs which undoubtedly improved the speed and efficiency of cavity preparation but has many inevitable disadvantages. To overcome these, various newer caries excavation techniques have been suggested like air abrasion, air polishing, ultrasonic, Sono abrasion, lasers and the chemomechanical caries removal technique. Chemomechanical caries removal (CMCR) is a non-invasive technique of removal of caries via eliminating infected dentin. BRIX-3000, papain-based chemical mechanical agent, with a proteolytic enzyme obtained from leaves latex and fruits of green papaya (Carica Papaya) that acts as a chemical debriding agent. Another minimally invasive method of caries removal is by using polymer burs. The cutting edges will wear down in contact with harder materials, such as healthy dentin. The recruited patients will be distributed equally into three groups ü Group I – Conventional method (n=22) ü Group II – BRIX3000 (n=22) ü Group III - Smart Burs (n=22) Caries excavation will be done with respective agents, and the working time will be calculated. Microbial analysis will be carried out, thus all the samples will be evaluated for a total reduction in the bacterial count (CFU) and mean working time study hypothesis is that minimal invasive technique can prove that they can effectively remove all the caries as well preserve tooth structure |