| CTRI Number |
CTRI/2025/09/095499 [Registered on: 30/09/2025] Trial Registered Prospectively |
| Last Modified On: |
30/05/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparative Evaluation Of Different Caries Detection Methods After Cavity Preparation - An Invivo Study |
|
Scientific Title of Study
|
COMPARATIVE EVALUATION OF VISUAL TACTILE METHOD VERSUS CARIES DETECTOR DYE IN DETECTION OF CARIES AFTER CAVITY PREPARATION AGAINST LASER FLUORESCENCE DEVICE (DIAGNODENT): AN IN-VIVO STUDY |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Boddepalli Divya |
| Designation |
Post Graduate |
| Affiliation |
ANIL NEERUKONDA INSTITUTE OF DENTAL SCIENCES |
| Address |
Department of conservative Dentistry and endodontics
Visakhapatnam
ANDHRA PRADESH
531162
India |
| Phone |
9182243709 |
| Fax |
|
| Email |
divyaboddepalli111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sudhakar naidu |
| Designation |
Professor |
| Affiliation |
ANIL NEERUKONDA INSTITUTE OF DENTAL SCIENCES |
| Address |
Department of Conservative dentistry and Endodontics
Visakhapatnam
ANDHRA PRADESH
531162
India |
| Phone |
9182243709 |
| Fax |
|
| Email |
padmabrajeswari@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Boddepalli Divya |
| Designation |
Post Graduate |
| Affiliation |
ANIL NEERUKONDA INSTITUTE OF DENTAL SCIENCES |
| Address |
Department of conservative Dentistry and endodontics
Visakhapatnam
ANDHRA PRADESH
531162
India |
| Phone |
9182243709 |
| Fax |
|
| Email |
divyaboddepalli111@gmail.com |
|
|
Source of Monetary or Material Support
|
| Anil neerukonda institute of dental sciences, sangivalasa, Bheemunipatnam mandal, Visakhapatnam District, Andhrapradesh, India. pin code 531162 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 B Divya |
ANIL NEERUKONA INSTITUTE OF DENTAL SCIENCES |
Department of Conservative Dentistry and Endodontics
Visakhapatnam
ANDHRA PRADESH |
9182243709
divyaboddepalli111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE-ANIDS |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K026||Dental caries on smooth surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
caries detecting methods |
visual tactile method versus caries detector dye against LF device(Diagnodent) |
| Intervention |
caries detection after cavity preparation |
class 2 cavity preparation will be done followed by evaluation with three caries detection methods. duration- done on first day, 1hour |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Moderate class II caries involved in posterior teeth (permanent premolars and molars)
Moderate caries risk
Presence of at least one open carious lesion into dentin on occlusal surface
|
|
| ExclusionCriteria |
| Details |
Primary/mixed dentition
High caries risk
Teeth with restorations
Pulp involvement and periapical pathology
Teeth with development anomalies and disturbances
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| caries detection methods like visual tactile examination, caries detector dyes, DIAGNOdent(laser fluorescence device) can effectively detect caries in cavities and ensure complete caries removal particularly in proximal areas |
Diagnodent(LF) values before and after cavity preparation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
10/10/2025 |
| 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)
Modification(s)
|
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
|
|
This In Vivo study includes selection of 48 permanent premolars
and molars with class II dental caries from adult patients aged 19 to 60
years, who referred to the Department of conservative dentistry and endodontics
in Anil Neerukonda institute of dental sciences. Visual and tactile examination of the relevant
dental carious lesion will be done with mouth mirror and probe and
Radiographs (IOPA, Bitewing) will be taken to assess the caries extension.
On the basis of the
radiographic investigation, the patients will be equally divided into three
groups.
|
In group I, Under rubber dam isolation of the carious tooth, the
LF readings will be noted preoperatively prior to cavity preparation.
Cavity preparation will be
done with conventional visual and tactile method using airotor and burs (Mani).
Then, the tooth is rinsed
and dried gently with compressed air. Ensure satisfactory residual caries
removal by both optical and tactile assessment with mouth mirror and probe.
Second LF readings noted after cavity preparation. In group II, Under rubber dam isolation of the carious tooth, the
LF readings will be noted preoperatively prior to cavity preparation.
Cavity preparation will be
done with conventional method using airotor and burs.
After cavity preparation,
caries detecting dye will be applied in the cavity and left in
place for 10 seconds, then rinsed off by a copious amount of water. After air
drying, the cavity will be examined by a mouth mirror to detect stained
dentin sites, dye stained
areas will be removed to ensure satisfactory caries removal. Second LF readings
noted after cavity preparation. In group III, Under
rubber dam isolation, the first LF readings will be noted preoperatively
prior to cavity preparation. Cavity preparation will be done with the visual and
tactile examination using airotor and burs. After conventional cavity
preparation, the second LF readings will be noted and tabulated.
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