| CTRI Number |
CTRI/2022/04/041809 [Registered on: 12/04/2022] Trial Registered Prospectively |
| Last Modified On: |
08/04/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Other (Specify) [Chemomechanical caries removal agent] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Removal of deep caries with chemical solutions |
|
Scientific Title of Study
|
Efficacy Of Chemomechanical Method of Caries Removal Using BRIX- 3000 in vital pulp therapy- A Randomized Controlled Trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Janani Balachandran |
| Designation |
Reader |
| Affiliation |
Sree Balaji Dental College and Hospital |
| Address |
Velachery Rd, VGP Rajesh Nagar, Pallikaranai, Chennai, Tamil Nadu
Chennai
TAMIL NADU
600100
India |
| Phone |
9941100678 |
| Fax |
|
| Email |
janani.balachandran@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Janani Balachandran |
| Designation |
Reader |
| Affiliation |
Sree Balaji Dental College and Hospital |
| Address |
Velachery Rd, VGP Rajesh Nagar, Pallikaranai, Chennai, Tamil Nadu
Chennai
TAMIL NADU
600100
India |
| Phone |
9941100678 |
| Fax |
|
| Email |
janani.balachandran@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Janani Balachandran |
| Designation |
Reader |
| Affiliation |
Sree Balaji Dental College and Hospital |
| Address |
Velachery Rd, VGP Rajesh Nagar, Pallikaranai, Chennai, Tamil Nadu
Chennai
TAMIL NADU
600100
India |
| Phone |
9941100678 |
| Fax |
|
| Email |
janani.balachandran@gmail.com |
|
|
Source of Monetary or Material Support
|
| Clinical area, Dr. A.P.J Abdul Kalam Education and Research Center and Super Specialty Dental Clinic, |
| nil |
|
|
Primary Sponsor
|
| Name |
Indian Dental Research Foundation IDA |
| Address |
Prabhadevi , Mumbai |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Janani Balachandran |
Dr. A.P.J. Abdul Kalam Education & Research Centre and Superspeciality Dental Clinic |
Block No. 6, 1st Floor, 386, Sane Guruji Premises,, Opp. Siddhivinayak Temple, Swatantrya Veer Savarkar Marg, Prabhadevi, Mumbai, Maharashtra 400025
Mumbai (Suburban)
MAHARASHTRA |
9941100678
janani.balachandran@gmail.com |
| Dr Janani Balachandran |
Sree Balaji Dental College and Hospital |
Velachery Rd, VGP Rajesh Nagar, Pallikaranai, Chennai, Tamil Nadu 600100
Chennai
TAMIL NADU |
9941100678
janani.balachandran@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee A.P.J. Abdul Kalam Education & Research Centre and Super speciality Dental Clinic |
Approved |
| Sree Balaji Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Chemomechanical preparation using BRIX 3000 |
After rubber dam isolation, preparation was done with high speed bur just enough to enlarge the diameter of cavity. In case of a wide cavity Brix 3000 was directly applied. Application of the material was done according to the manufacturer’s instructions. The material was applied with a blunt spoon excavator and left for 2 minutes (allowing it to interact with infected dentin). At first, Brix gel was clear, but later on, due to its effect (decomposition of the carious lesion) it turned darker (turbid). The decayed dentin, which became softened (due to the action of the material) was then scraped away using a blunt excavator in a pendulum movement without pressure. If necessary, the procedure was repeated to get healthy dentin until the gel remained clear (without any evidence of darkish colour) indicating that the infected carious lesion was completely removed. Then the cavity was examined by tactile sensation and visual inspection (Banerjee et al., 2000) to assess the complete removal of the carious lesion. |
| Comparator Agent |
Traditional cavity preparation using high speed carbide bur |
After rubber dam isolation caries removal was done using a high speed hand piece (NSK) with a round carbide bur(SS White, Germany). The cavities were then checked using the same criteria that was used with group 1 (G1)to check for the remaining caries.After the completion of caries removal, by either method, cavities were restored according to the depth of the cavity. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Bilateral open carious lesion with dentin involvement
2.Opening should be large enough to allow penetration of a small excavator
3.No proximal caries as evidenced by intra oral periapical radiographs
•Teeth without clinical or radiographic evidence of pulp, furcation or periapical pathology.
|
|
| ExclusionCriteria |
| Details |
1.History of pain and pulp exposure.
2.Presence of sinus opening with pus discharge and radiographic evidence of furcation or periapical pathology.
3.Hypersensitivity to any of the component of BRIX 3000.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessing the pain scores (HP VAS) and time (T) taken for deep caries excavation using chemomechanical method of cavity preparation as compared to conventional method. |
HP VAS scale taken after cavity preparation (post procedure). Time taken for the procedure recorded. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Higher success rates of vital pulp therapy when BRIX 3000 CMCP is used |
1, 3 and 6 months post-treatment |
|
|
Target Sample Size
|
Total Sample Size="134"
Sample Size from India="134"
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)
|
25/04/2022 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
AIM - The purpose of the current study was to evaluate the efficacy of chemomechanical method of caries removal using BRIX 3000 as compared to conventional caries excavation with burs in vital pulp therapy
METHODOLOGY - The double-blind randomized control trial was conducted on 134 patients who were randomly divided into chemomechanical caries removal with BRIX 3000(Group I - 67 patients) and high-speed bur excavation with aerator (Group II - 67 patients). Time (T) required for cavity preparation and pain perceived by the patients (HP - VAS scores) were recorded. After the final restoration patients were recalled at the end of 1,3 and 6 months for follow-up. During the follow-up recalls the success of pulp capping procedures was recorded by calibrated examiners who evaluated the pulp (Endo frost, Dry Ice) and periapical status (IOPA). The results were statistically analyzed by Independent sample t-test and Mann Whitney U test.
CONCLUSION - The primary outcome measures suggested more time taken with BRIX 3000 as compared to high-speed burs. however, the patient felt more comfortable and the HP VAS scores are significantly lower for BRIX 3000. This method can eliminate the need for local anesthesia for deep caries excavations.
BRIX 3000 effectively removed only the carious dentin leaving behind sound dentin for remineralization, this will lead to increased success rates achieved in pulp capping procedures. BRIX 3000 is an important aid in this revolution towards minimally invasive dentistry and is an important material in the dental arsenal. |