| CTRI Number |
CTRI/2021/07/034545 [Registered on: 02/07/2021] Trial Registered Prospectively |
| Last Modified On: |
01/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of decay removal using four different methods. |
|
Scientific Title of Study
|
Comparative evaluation of clinical and microbiological assessment of caries excavation using conventional bur, smart bur, chemomechanical method and ErCr:YSGG laser : An invivo study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prerana Kothari S |
| Designation |
Post Graduate |
| Affiliation |
Rajarajeswari Dental College And Hospital |
| Address |
Rajarajeswari Dental College And Hospital No 14 Ramohalli Cross Mysore Road Kumbalgodu Bengaluru Karnataka Roon No 6 Department of Conservative Dentistry and Endodontics 2nd Floor Rajarajeswari Dental College And Hospital No 14 Ramohalli Cross Mysore Road Kumbalgodu Bengaluru Karnataka Bangalore KARNATAKA 560074 India |
| Phone |
09901365788 |
| Fax |
08028437468 |
| Email |
preranakothari1996@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Annapoorna Kini |
| Designation |
Professor |
| Affiliation |
Rajarajeswari Dental College And Hospital |
| Address |
Room No 6 Department of Conservative Dentistry and Endodontics 2nd floor Rajarajeswari Dental College And Hospital No 14 Ramohalli Cross Mysore Road Kumbalgodu Bengaluru Karnataka Room No 6 Department of Conservative Dentistry and Endodontics 2nd floor Rajarajeswari Dental College And Hospital No 14 Ramohalli Cross Mysore Road Kumbalgodu Bengaluru Karnataka Bangalore KARNATAKA 560074 India |
| Phone |
9916917852 |
| Fax |
08028437468 |
| Email |
kinimai@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Annapoorna Kini |
| Designation |
Professor |
| Affiliation |
Rajarajeswari Dental College And Hospital |
| Address |
Room No 6 Department of Conservative Dentistry and Endodontics 2nd floor Rajarajeswari Dental College And Hospital No 14 Ramohalli Cross Mysore Road Kumbalgodu Bengaluru Karnataka Room No 6 Department of Conservative Dentistry and Endodontics 2nd floor Rajarajeswari Dental College And Hospital No 14 Ramohalli Cross Mysore Road Kumbalgodu Bengaluru Karnataka Bangalore KARNATAKA 560074 India |
| Phone |
9916917852 |
| Fax |
08028437468 |
| Email |
kinimai@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajarajeswari Dental College and Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Prerana Kothari S |
| Address |
Rajarajeswari Dental College And Hospital No 14 Ramohalli Cross Mysore Road Kumbalgodu Bengaluru Karnataka |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prerana Kothari S |
Rajarajeswari Dental College and Hospital |
Room No 6 Department of Conservative Dentistry and Endodontics 2nd floor
No 14 Ramohalli Cross Mysore Road Kumbalgodu Bengaluru Karnataka 560074 Bangalore KARNATAKA |
09901365788
preranakothari1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Chemo mechanical method using Brix 3000 gel. |
BRIX3000 gel (Brix Srl Argentina) will be applied with a blunt spoon excavator allowing it to work for 2 mins. Once the applied gel turned turbid, it will be removed by using Hu-Friedy spoon excavator in pendulum motion without pressure. This procedure will be repeated till the healthy dentin is obtained. When applied for a second or third time, no color change in the gel will be observed, which indicates that there is no presence of carious infected tissue. |
| Intervention |
Er:Cr:YSGG Laser method. |
Er:Cr:YSGG laser with a frequency of 20 Hz will be set to obtain a power of 800W.Caries excavation will be carried out under non-contact mode using MZ8 laser tip under continuous water spray to decrease energy density. This facilitates the excavation of caries without change of operating parameters once set. Clinical evaluation of caries excavation will be done using Ericson’s visual and tactile criteria for the absence of discoloration and smooth passage of a William’s Probe with no tug back or catches.
|
| Intervention |
Polymer Bur method. |
Caries excavation will be done by using (SS White Smart Burs II) sizeRA4, RA6 and RA8 with a micromotor handpiece according to the size of the lesion, running at slow speed without a water coolant. Caries will be excavated in circular movements starting from the center of the lesion to the periphery, as recommended by the manufacturer. Excavation will be stopped when the instrument becomes macroscopically abraded and blunted and will no longer be able to remove the tissue. New polymer burs will be used for each tooth. |
| Comparator Agent |
Tungsten Carbide No 330-bur method. |
Caries excavation will be done by using Tungsten Carbide No 330 bur with an NSK Airotor handpiece. Intermittent cutting along with water coolant will be done until all the caries are excavated. The complete removal of caries will be checked according to Erickson criteria, i.e., optical(color) and tactile hardness. The color will be checked visually and hardness of the lesion lesion will be checked by the William’s Probe until a leather-hard texture and sharp scratching sound is heard. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1)Class 1 dentinal caries with broad occlusal cavitated lesion on permanent molars.
2)Radiographically carious lesion has to be confined to outer dentin of occlusal surface.
3)Patient aged between 18-40 years old.
4)Teeth with intact buccal/lingual surface.
5)RDT ≥ 1.5 mm
|
|
| ExclusionCriteria |
| Details |
1)Permanent molars with clinical and radiological signs and symptoms of pulpal and periapical lesions.
2)Teeth with any developmental anomaly.
3)Teeth with proximal caries and pulpal involvement.
4)Teeth with previous restoration and fractured crown.
5)Presence of white spot lesions.
6)Hypoplastic or hypomineralized teeth.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the caries removal efficacy in terms of microbiological assessment and efficiency in terms of time taken by Tungsten Carbide No 330 bur,Polymer bur,Brix 3000 gel,Er:Cr:YSGG laser |
Patient recalled for the follow up appointments at 3,6 and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Good oral hygiene is achieved. |
Patient recalled for the follow up appointments at 3,6 and 12 months |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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 3 |
|
Date of First Enrollment (India)
|
20/07/2021 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
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 - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - preranakothari1996@gmail.com
- For how long will this data be available start date provided 20-07-2021 and end date provided 20-07-2022?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
TITLE OF THE TOPIC: COMPARATIVE EVALUATION OF CLINICAL AND
MICROBIOLOGICAL ASSESSMENT OF CARIES EXCAVATION USING CONVENTIONAL BUR,SMART
BUR,CHEMOMECHANICAL METHOD AND ErCr:YSGG LASER : AN INVIVO STUDY.Dental caries is the most prevalent chronic disease in the global
population. It is characterised by the destruction of inorganic and dissolution
of organic material from tooth structure. The conventional
dentistry approach to caries treatment has been removing diseased tissue and
replacing it with a dental restorative material. Mechanical caries removal
traditionally involves the use of conventional tungsten carbide or round steel
burs and hand instruments. The disadvantages of these methods are overpreparation
of cavities, pain sensitivity and possible damage to the pulp. Since the dentistry has advanced so much in 21st century
that G.V.Blacks “Extension for prevention†has transformed to “Prevention for
Extension.†With the advent of adhesive materials and greater
understanding of the disease process we are moving into era of Minimal intervention dentistry.The
newer method for caries removal which follows the principle of minimally
invasive dentistry has developed recently since last decades.These include laser, chemo-mechanical
method, air abrasion, air polishing, ultrasonic, ozone method, polymer burs and
enzymes. The aim of the study is to compare the caries
removal efficacy in terms of microbiological assessment and efficiency in terms
of time taken by Tungsten Carbide Bur No.330,Polymer bur,BRIX 3000 and ErCr:YSGG Laser. INCLUSION CRITERIA: 1)Class 1 dentinal caries with
broad occlusal cavitated lesion on permanent molars. (2)Radiographically carious lesion has to be confined to outer dentin of occlusal surface. (3)Patient aged between 18-40 years old. (4)Teeth with intact buccal/lingual surface. 5)RDT ≥ 1.5 mm. EXCLUSION CRITERIA: 1)Permanent molars with clinical
and radiological signs and symptoms of pulpal and periapical lesions. (2)Teeth with any developmental
anomaly. (3)Teeth with proximal caries and
pulpal involvement. (4)Teeth with previous restoration
and fractured crown. (5)Presence of white spot lesions. (6)Hypoplastic or hypomineralized
teeth. A total of 60
patients between the age group 18 to 40 years fulfilling the inclusion criteria
will be included in the study after obtaining informed consent. Before starting
the procedure, preoperative radiograph will be taken and RDT will be
determined. All potential participants will be selected randomly and will be
divided into 4 groups depending on caries excavation methods. Rubber Dam will be
used for isolation of the respective tooth. Local anesthesia will be given if
the patient experiences pain or sensitivity during caries excavation. Caries
excavation will be done with the following methods mentioned above. Time taken will be
measured using a stopwatch from the beginning of caries removal to confirmation
of complete excavation of caries clinically. For Microbiological
Evaluation two samples of
carious material will be collected (one before caries excavation and one after)
in Eppendorf tubes that contains saline. They will be transported to the
laboratory within 2 hrs. The samples will then be placed on blood agar plates and
will be incubated aerobically at 37ºC for 48 hrs. Using the Digital Colony
Counter total number of colonies formed will be determined and expressed as
CFU/ml. Colony forming units per sample will be estimated before and after the
treatment and will then be processed according to S.O.P of RRMCH.
|