| CTRI Number |
CTRI/2025/05/086562 [Registered on: 08/05/2025] Trial Registered Prospectively |
| Last Modified On: |
07/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Clinical and X-ray Evaluation of Er:YAG Laser-Assisted Pulp Treatment in Permanent Teeth with Cavity Exposure |
|
Scientific Title of Study
|
Randomized controlled trial of direct pulp capping using laser |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rakesh Yadav |
| Designation |
Professor |
| Affiliation |
King Georges Medical University |
| Address |
Department of Conservative Dentistry and Endodontics, King Georges Medical University, Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
94152811156 |
| Fax |
|
| Email |
rakeshanita10@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rakesh Yadav |
| Designation |
Professor |
| Affiliation |
King Georges Medical University |
| Address |
Department of Conservative Dentistry and Endodontics, King Georges Medical University, Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
94152811156 |
| Fax |
|
| Email |
rakeshanita10@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rakesh Yadav |
| Designation |
Professor |
| Affiliation |
King Georges Medical University |
| Address |
Department of Conservative Dentistry and Endodontics, King Georges Medical University, Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
94152811156 |
| Fax |
|
| Email |
rakeshanita10@yahoo.in |
|
|
Source of Monetary or Material Support
|
| King Georges Medical University, Lucknow |
|
|
Primary Sponsor
|
| Name |
Dr Rakesh Kumar yadav |
| Address |
Department of Conservative Dentistry and Endodontics
King Georges Medical University Lucknow |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| nil |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rakesh Kumar Yadav |
King Georges Medical University |
Department of conservative Dentistry and endodontics, Faculty of Dental sciences
Lucknow
UTTAR PRADESH |
9415281156
rakeshanita10@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| King Georges Medical University, Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ICD-10 Condition: K040/ Pulpitis |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group 1 : Biodentine which is a bioactive, tricalcium silicate cement |
In group 1, enamel preparation was done with a high-speed handpiece and diamond bur, while carious dentin was removed using a low-speed handpiece and carbide bur. In deeper sections, a sharp hand excavator was used to ensure thorough removal of carious tissue. In cases of pulp exposure, haemorrhage was controlled using a cotton pellet moistened with 2.5% sodium hypochlorite, applied for ten minutes. The tooth was then rinsed with saline to remove any residual sodium hypochlorite and dried using a cotton pellet. Biodentine was mixed per the manufacturer’s instructions and applied directly to the pulp exposure site, followed by restoration with composite resin. Radiographs were taken regularly to assess the clinical and radiographic condition. |
| Intervention |
Group 2 (Laser + Biodentine) for laser Er: Yag laser is used which is a soft and hard tissue laser |
For enamel cutting and cavity opening, an Er:YAG laser was set to an output power of 8.0 W, energy of 400 mJ, frequency of 20 Hz. For carious dentin removal, the settings included an output power of 4.0 W, energy of 200 mJ, frequency of 20 Hz. The exposed pulp was irradiated at settings of output power of 0.5 W, energy of 30 mJ, frequency of 15 Hz with no water . Irradiation was performed 5-20 times in a sweeping manner in continuous wave mode until adequate hemostasis was achieved.
After irradiation of pulp with Er:YAG laser the exposed pulp was covered with Biodentine was applied to cover the exposed pulp and the restored with composite resin
Radiographs were taken regularly to assess the clinical and radiographic condition. |
| Intervention |
Group 3 (Laser alone) only Er: YAG laser is used followed by a restoration |
For enamel cutting and cavity opening, an Er:YAG laser was set to an output power of 8.0 W, energy of 400 mJ, frequency of 20 Hz. For carious dentin removal, the settings included an output power of 4.0 W, energy of 200 mJ, frequency of 20 Hz. The exposed pulp was irradiated at settings of output power of 0.5 W, energy of 30 mJ, frequency of 15 Hz with no water . Irradiation was performed 5-20 times in a sweeping manner in continuous wave mode until adequate hemostasis was achieved. After irradiation of pulp with Er:YAG laser the exposed pulp was covered with resin modified GIC. Radiographs were taken regularly to assess the clinical and radiographic condition. |
|
|
Inclusion Criteria
|
| Age From |
11.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Permanent teeth with deep caries with remaining dentin thickness less than 0.5 mm
Positive responses to cold and electric pulp tests
Absence of clinical symptoms
No radiographic evidence of periapical changes
No associated swelling pus exudate or abnormal mobility
Restorable teeth
|
|
| ExclusionCriteria |
| Details |
Immunocompromised or pregnant patients
Antibiotics and analgesic use within the week before the treatment
Teeth with irreversible pulpitis or pulp necrosis
Tooth showing abnormal response to electric pulp testing and heat test
Sensitivity to percussion or touch.
Pulp exposure greater than 2 mm
Pulp exposure before complete caries removal
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome consisted of clinical symptoms and radiographic symptoms. For clinical criteria, the evaluation included pulp sensibility tests,spontaneous pain, mobility, sinus tract formation, and performing palpation and percussion tests. For radiographic criteria included detecting any radiolucency at the periapical or furcation areas, assessing for pathological changes like internal and external resorption, checking for periodontal ligament widening, and monitoring dentin bridge formation. |
3 months, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| clinical criteria, the evaluation included pulp sensibility tests,spontaneous pain, mobility, sinus tract formation, & performing palpation & percussion tests. For radiographic criteria included detecting any radiolucency at the periapical or furcation areas, assessing for pathological changes like internal & external resorption, checking for periodontal ligament widening, & monitoring dentin bridge formation. |
3 months, 6 months & 12 months |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
20/05/2025 |
| 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="3"
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
|
This study aimed to evaluate the clinical and radiographic outcomes of direct pulp capping (DPC) in permanent teeth using Er:YAG laser-assisted techniques compared to conventional methods. The trial involved patients with deep carious lesions and pinpoint pulp exposures, meeting specific inclusion criteria. Following standardized protocols, pulp exposure sites were managed with either laser-assisted or traditional techniques, and outcomes were assessed over a defined follow-up period. The primary objective was to assess the effectiveness of the Er:YAG laser in preserving pulp vitality and promoting healing. |