| CTRI Number |
CTRI/2025/03/082249 [Registered on: 12/03/2025] Trial Registered Prospectively |
| Last Modified On: |
10/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Two Types of Laser Therapy Affecting Healing After Minimally Invasive Dental Implant Surgery. |
|
Scientific Title of Study
|
Comparative Evaluation of the effect of Low-Level Laser Therapy using two different wavelengths on post-surgical healing in patients undergoing Piezoelectric Flapless Implant Surgery |
| 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 Priyanshu Priyam |
| Designation |
POSTGRADUATE |
| Affiliation |
Manav Rachna DentaL College And Hospital |
| Address |
Room no 6 Department of Prosthodontics Manav Rachna Dental College Sector 43 Faridabad
Faridabad
HARYANA
121004
India |
| Phone |
8544263686 |
| Fax |
|
| Email |
bypriyanshu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pankaj Dhawan |
| Designation |
Professor and HOD |
| Affiliation |
Manav Rachna Dental College Faridabad |
| Address |
Room no 6 Department of Prosthodontics Manav Rachna Dental College Sector 43 Faridabad
Faridabad
HARYANA
121004
India |
| Phone |
9810382383 |
| Fax |
|
| Email |
dhawan.sds@mrei.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pankaj Dhawan |
| Designation |
Professor and HOD |
| Affiliation |
Manav Rachna Dental College Faridabad |
| Address |
Room no 6 Department of Prosthodontics Manav Rachna Dental College Sector 43 Faridabad
HARYANA
121004
India |
| Phone |
9810382383 |
| Fax |
|
| Email |
dhawan.sds@mrei.ac.in |
|
|
Source of Monetary or Material Support
|
| Manav Rachna Dental College And Hospital, Faridabad, Haryana-121004 |
|
|
Primary Sponsor
|
| Name |
Priyanshu Priyam |
| Address |
Room no 6 Department of Prosthodontics Manav Rachna Dental College Sector 43 Faridabad |
| Type of Sponsor |
Private 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 Priyanshu Priyam |
Manav Rachna Dental College and Hospital |
Room no 6, Department of Prosthodontics, Manav Rachna Dental College and Hospital sector 43 ,Faridabad, Haryana-121004
Faridabad
HARYANA |
08544263686
bypriyanshu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Clearance Certificate |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K068||Other specified disorders of gingiva and edentulous alveolar ridge, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
LLLT at 650nm |
To evaluate post surgical healing in
patient undergoing Piezoelectric
flapless implant surgery along with
LLLT at 650nm at 25mW, 80mJ for 1
min on 3rd day, 14th day and 6th
week post operatively |
| Comparator Agent |
LLLT at 940nm |
To evaluate post surgical healing in
patient undergoing Piezoelectric
flapless implant surgery along with
LLLT at 940nm
min on 3rd day, 14th day and 6th
week post operatively |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
a) Patients within age group of 20-40 years with missing teeth needing implant placement
b) Willingness to participate in the study and provide informed consent
c) Availability for follow-up visits as per the study protocol.
d) Patients with adequate bone height and width to accommodate implant of appropriate dimension |
|
| ExclusionCriteria |
| Details |
e) Patients with contraindications to Low-Level Laser Therapy (LLLT) such as photosensitivity,
active cancer in the treatment area or history of radiation therapy to the head or neck region
f) Patients having known systemic diseases contraindicated for implant placement
g) Inability or unwillingness to comply with the study protocol or attend follow-up visits
h) Pregnant and lactating women
i) Use of medications or substances known to interfere with wound healing/patients with history of intake of immunosuppressive drugs, anti coagulants and anti-cancer drugs three
months prior to the study
j) Patients undergoing orthodontic treatment
k) Patients having known history of bone disorders (e.g. osteoporosis, osteoarthritis)
l) Severe periodontal disease or active oral infections at the implant site |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| If there is a significant difference in post-operative healing between patients undergoing LLLT at 650 nm wavelength as compared to 940 nm wavelength following piezoelectric flapless implant surgery |
3rd day, 14th day and 6th week post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
21/03/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
The study would be conducted over a period of 1.5 years. The study would involve 34 patients requiring implant placement due to missing teeth. The patients would be divided into two equal groups of 17 each. Group 1 would receive LLLT with a diode laser at a wavelength of 650 nm, while Group 2 would receive LLLT at 940 nm. Both groups would undergo implant insertion using piezoelectric flapless surgery, and LLLT would be administered before surgery and at 24 and 36 hours post-surgery. Healing outcomes would be assessed using the Inflammatory Proliferative Remodeling (IPR) scale on 3rd day 14th day and 6th week post operatively1 . Sample Size The study would include a total of 34 patients which was determined using G Power Software (version 3.0.10). The sample size calculation considered an effect size of 0.912, a 5% level of precision, a 95% confidence level, and 80% power. Patients would be divided equally into two groups, with 17 patients in each group. |