| CTRI Number |
CTRI/2025/04/084761 [Registered on: 15/04/2025] Trial Registered Prospectively |
| Last Modified On: |
14/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Which Laser Works Better for Healing and Comfort During Dental Implant Surgery |
|
Scientific Title of Study
|
Comparative Evaluation of Two Diode Laser Wavelengths on Soft Tissue Healing, Postoperative Pain and Temperature Rise during
Second-Stage Implant Surgery: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Daisy Hemchandra Sinha |
| Designation |
Post Graduate Student |
| Affiliation |
Manav Rachna International Institute of Research and Studies |
| Address |
Manav Rachna Dental College, Department of Prosthodontics and Crown and Bridge, Room No. 6, 1st Floor, Q Block, Faridabad
Faridabad
HARYANA
121004
India |
| Phone |
9327719541 |
| Fax |
|
| Email |
daisysinha2602@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shrimant Raman |
| Designation |
Reader |
| Affiliation |
Manav Rachna International Institute of Research and Studies |
| Address |
Manav Rachna Dental College, Department of Prosthodontics and Crown and Bridge, Room No. 6, 1st Floor, Q Block, Faridabad
Faridabad
HARYANA
121004
India |
| Phone |
9971246808 |
| Fax |
|
| Email |
shrimantraman.sds@mrei.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Daisy Hemchandra Sinha |
| Designation |
Post Graduate Student |
| Affiliation |
Manav Rachna International Institute of Research and Studies |
| Address |
Manav Rachna Dental College, Department of Prosthodontics and Crown and Bridge, Room No. 6, 1st Floor, Q Block, Faridabad
Faridabad
HARYANA
121004
India |
| Phone |
9327719541 |
| Fax |
|
| Email |
daisysinha2602@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self, Manav Rachna Dental College, Department of Prosthodontics and crown and bridge, Room no 6, Q block,1st Floor, Faridabad, Haryana 121004, India |
|
|
Primary Sponsor
|
| Name |
Dr Daisy Hemchandra Sinha |
| Address |
Manav Rachna Dental College, Department of Prosthodontics and Crown and Bridge, Room no. 6, 1st Floor, Q- Block, Faridabad, Haryana 121004, India |
| 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 Daisy Hemchandra Sinha |
Manav Rachna International Institute of Research and Studies |
Department of Prosthodontics and Crown and Bridge, Room no.6, 1st floor , Q Block, Faridabad, Haryana 121004, India
Faridabad
HARYANA |
9327719541
daisysinha2602@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Manav Rachna Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients with implant insertion recruited for conventional loading |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Diode laser wavelength 650nm for second stage implant surgery |
Soft tissue healing using healing index at 1st day, 3rd day and 7th day postoperatively.
Postoperative pain using VAS scale at 1st day, 3rd day and 7th day postoperatively.
Temperature rise using a thermal imaging camera prior to surgery, immediately after uncovering, 15sec after uncovering. |
| Comparator Agent |
Diode laser wavelength 940nm for second stage implant surgery
|
Soft tissue healing using healing index at 1st day ,3rd day and 7th day postoperatively.
Postoperative pain using VAS scale at 1st day, 3rd day, 7th day postoperatively.
Temperature rise using a thermal imaging camera prior to surgery, Immediately after
uncovering, 15sec after uncovering . |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Healthy patients with sufficient bone volume for implant placement
Co-operative patient, willing to give consent
No history of systemic conditions that may affect implant healing (e.g., uncontrolled
diabetes) |
|
| ExclusionCriteria |
| Details |
Patients with Ongoing uncontrolled periodontal disease or active oral infections
Patients with a known history of any systemic diseases
Patients with a history of smoking
Patients with peri-implant bone loss in the peri-apical radiograph |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare the effectiveness of two diode laser wavelengths (650nm and
940nm) in soft tissue healing using healing index.
To evaluate and compare the effectiveness of two diode laser wavelengths (650nm and
940nm) in reducing postoperative pain using VAS scale.
To evaluate and compare the temperature rise in peri-implant tissues during the
application of 650nm and 940nm diode lasers using a thermal imaging camera. |
Soft tissue healing on 1st day,3rd day, and 7th day postoperatively.
Postoperative pain on 1st day, 3rd day, 7th day postoperatively.
Temperature rise prior to surgery, immediately after uncovering, and 15 sec after uncovering.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="22"
Sample Size from India="22"
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)
|
12/05/2025 |
| 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="6"
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 randomized controlled parallel arm trial aims to comparatively evaluate the effects of two diode laser wavelengths 650 nm and 940 nm on soft tissue healing, postoperative pain and temperature rise during second stage dental implant surgery. The study will include assessment parameters such as the Landry, Turnbull and Howley healing index for soft tissue healing, the Visual Analog Scale for postoperative pain evaluation, and thermal imaging using a Hikmicro Mini2Plus camera to monitor intraoperative temperature changes. The results will provide clinical insights into the optimal diode laser wavelength for enhanced healing and patient comfort in implantology.
|