| CTRI Number |
CTRI/2024/11/076961 [Registered on: 18/11/2024] Trial Registered Prospectively |
| Last Modified On: |
15/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Laser vs. Traditional Dentistry: A New Approach to Treating Cavities |
|
Scientific Title of Study
|
"Deep Caries Management with Er:YAG
Laser: A Multifaceted Randomized Controlled Trial Comparing Er
Laser Technology with Conventional Methods for Predictive Deep Caries Management in Restorative Dentistry" |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1303-5945 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sourabh T J |
| Designation |
Assistant Professor |
| Affiliation |
government dental college and research institute |
| Address |
Department of Conservative Dentistry and Endodontics Government Dental College and Research Institute Bengaluru
Bangalore
KARNATAKA
560002
India |
| Phone |
9886433370 |
| Fax |
|
| Email |
sourabhtorvi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kiran Kuamar N |
| Designation |
Professor & Head |
| Affiliation |
government dental college and research institute |
| Address |
Department of Conservative Dentistry and Endodontics Government Dental College and Research Institute Bengaluru
KARNATAKA
560002
India |
| Phone |
9449588573 |
| Fax |
|
| Email |
sourabhtorvi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sourabh T J |
| Designation |
Assistant Professor |
| Affiliation |
government dental college and research institute |
| Address |
Department of Conservative Dentistry and Endodontics Government Dental College and Research Institute Bengaluru
KARNATAKA
560002
India |
| Phone |
9886433370 |
| Fax |
|
| Email |
sourabhtorvi@gmail.com |
|
|
Source of Monetary or Material Support
|
| department of conservative dentistry & ENdodontics, Government dental college & Research institute. |
|
|
Primary Sponsor
|
| Name |
DrSourabh T J |
| Address |
department of conservative dentistry and endodontics govt dental college and research institute Bengaluru |
| Type of Sponsor |
Government medical college |
|
|
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 sourabh T J |
department of conservative dentistry and endodontics |
room no 4, government dental college and research institute, Victoria campus, Bengaluru 560002
Bangalore
KARNATAKA |
9886433370
sourabhtorvi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee, government dental college and research institute, Bengaluru |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K025||Dental caries on pit and fissure surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Caries Excavation with Conventional Methods |
Subgroup A1: Caries Excavation and Biodentine Application on Teeth with No Pulpal Involvement:
The carious lesions will be excavated using conventional methods.
Following excavation, Biodentine will be applied as a pulp protection material.
Subgroup A2: Caries Excavation, Diode Laser Photobiomodulation, and Biodentine Application on Teeth with No Pulpal Involvement:
Caries excavation will be performed using conventional methods.
Diode laser photobiomodulation will be applied to the excavation site.
Biodentine will be applied as a pulp protection material.
Subgroup A3: Caries Excavation with Pulpal Exposure and Pulp Capping with Biodentine Application:
In cases with pulpal exposure during excavation, the exposed pulp will be capped with Biodentine.
Subgroup A4: Caries Excavation with Pulpal Exposure and Direct Pulp Capping with Biodentine and Diode Laser Photobiomodulation:
In cases with pulpal exposure during excavation, direct pulp capping will be performed using Biodentine.
Diode laser photobiomodulation will be applied in conjunction with Biodentine.
|
| Intervention |
Caries Excavation with Er:YAG Laser |
Subgroup B1: Caries Excavation and Biodentine Application on Teeth with No Pulpal Involvement:
The carious lesions will be excavated using Er:YAG laser technology.
Following excavation, Biodentine will be applied as a pulp protection material.
Subgroup B2: Caries Excavation, Diode Laser Photobiomodulation, and Biodentine Application on Teeth with No Pulpal Involvement:
Caries excavation will be performed using Er:YAG laser technology.
Diode laser photobiomodulation will be applied to the excavation site.
Biodentine will be applied as a pulp protection material.
Subgroup B3: Caries Excavation with Pulpal Exposure and Pulp Capping with Biodentine Application:
In cases with pulpal exposure during excavation, the exposed pulp will be capped with Biodentine.
Subgroup B4: Caries Excavation with Pulpal Exposure and Direct Pulp Capping with Biodentine and Diode Laser Photobiomodulation:
In cases with pulpal exposure during excavation, direct pulp capping will be performed using Biodentine.
Diode laser photobiomodulation will be applied in conjunction with Biodentine.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants with at least one deep carious lesion (class I occlusal decay and extending into dentin) in a permanent tooth.
2. Teeth testing normal to sensibility tests (tested with electric pulp tester and cold test)
3. Teeth having no visible changes in the radiograph at the apical area. |
|
| ExclusionCriteria |
| Details |
1. Pregnant or lactating individuals.
2. Individuals with extensive tooth decay requiring endodontic treatment or tooth extraction.
3. Teeth testing abnormal to sensibility tests.
4. Participants with a history of previous laser treatment on the same tooth.
5. Participants with known allergies or hypersensitivity to any of the materials used in the study.
6. Participants with developmental or acquired dental anomalies that may affect the study outcomes.
7. Participants with severe periodontal disease, active oral infections, or conditions affecting the oral mucosa.
8. Individuals with systemic health conditions or immunocompromised status that may affect the study outcomes.
9. Participants unable to provide informed consent or understand the study requirements due to language barriers, cognitive impairments, or any other reasons.
10. Individuals with a history of any medical or dental conditions that could interfere with the success of dental restorations.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Effects of Er
laser on cariogenic microorganisms and microbial load
Primary Outcome: Reduction in cariogenic microorganisms (e.g., Streptococcus mutans counts, overall microbial load within the cavity).
2. Comparison of patient experiences and assessments between Er
laser and rotary bur
Primary Outcome: Patient comfort (measured via Visual Analog Scale (VAS) for pain), procedure acceptability, and time required for caries excavation.
3. Longevity and clinical outcomes of restorations
Primary Outcome: Restoration success rate (no secondary caries, integrity of the restoration).
4. Outcome for successful direct pulp capping using Er
laser vs. conventional methods
Primary Outcome: Pulp vitality and successful healing (assessed via clinical and radiographic signs of pulp health).
5. Effects of photobiomodulation with diode laser in conjunction with Er
laser therapy |
Regular follow-ups at 3 months, 6 months, 1 year, and 2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The secondary outcomes include cavity cleanliness, patient comfort (anesthesia needs, anxiety), and postoperative sensitivity, alongside clinical metrics like secondary caries, restoration integrity, and pulpal healing. Additional focus is given to patient satisfaction and healing when photobiomodulation is used with Er
laser therapy. These outcomes offer a broader perspective on treatment efficacy and patient experience. |
Regular follow-ups at 3 months, 6 months, 1 year, and 2 years |
|
|
Target Sample Size
|
Total Sample Size="288"
Sample Size from India="288"
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)
|
29/11/2024 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Comparative Assessment of Er Laser Therapy Versus Conventional Methods in Deep Caries ManagementObjectives:- To evaluate the antimicrobial effects of Erlaser therapy on cariogenic microorganisms and microbial load within therapeutic cavities compared to conventional methods (manual excavation and rotary methods).
- To compare patient experiences and objective assessments of Erlaser versus rotary bur methods in terms of excavation time, patient comfort, and acceptability.
- To analyze the longevity and clinical outcomes of restorations prepared with Erlaser cavities compared to conventional cavity preparation over a defined follow-up period.
- To investigate outcomes of direct pulp capping using Erlaser technology versus conventional methods in the management of deep caries.
- To assess the impact of adjunctive photobiomodulation with a diode laser alongside Erlaser therapy for managing deep caries lesions, with and without pulp involvement.
Primary Outcomes: 1. Reduction in microbial load 2. Patient comfort and procedural time 3. Restoration success rate over time 4. Pulp vitality in direct pulp capping 5. Success of photobiomodulation in lesion resolution Timeline: Immediate and short-term follow-up (within 1 week) for microbial reduction and patient comfort. Regular follow-ups at 3 months, 6 months, 1 year, and 2 years for assessing restoration longevity, pulp vitality, and clinical outcomes of photobiomodulation. |