| CTRI Number |
CTRI/2026/01/100334 [Registered on: 05/01/2026] Trial Registered Prospectively |
| Last Modified On: |
05/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
TO EVALUATE THE EFFECTIVENESS OF LOW LEVEL LASER THERAPY (LLLT) USING 810nm DIODE LASER ON IMPLANT STABILITY MEASURED BY RESONANCE FREQUENCY ANALYSIS (RFA)— A RANDOMIZED CONTROLLED CLINICAL TRIAL |
|
Scientific Title of Study
|
To Evaluate The Effectiveness Of Low Level Laser Therapy (LLLT) Using 810nm Diode Laser On Implant Stability Measured By Resonance Frequency Analysis (RFA)— A Randomized Controlled Clinical 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 Lakshay saini |
| Designation |
Post Graduate student |
| Affiliation |
JN Kapoor DAV (c) Yamunanagar |
| Address |
Dept of Periodontology & Oral Implantology, JN Kapoor Model town yamunanagar, Haryana 135001
Model town yamunanagar haryana 135001
Yamunanagar
HARYANA
131301
India |
| Phone |
09416060126 |
| Fax |
|
| Email |
lakshayssainis@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lakshay saini |
| Designation |
Post Graduate student |
| Affiliation |
JN Kapoor DAV (c) Yamunanagar |
| Address |
Dept of Periodontology & Oral Implantology, JN Kapoor Model town yamunanagar, Haryana 135001
Model town yamunanagar haryana 135001
Yamunanagar
HARYANA
131301
India |
| Phone |
09416060126 |
| Fax |
|
| Email |
lakshayssainis@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lakshay saini |
| Designation |
Post Graduate student |
| Affiliation |
JN Kapoor DAV (c) Yamunanagar |
| Address |
Dept of Periodontology & Oral Implantology, JN Kapoor Model town yamunanagar, Haryana 135001
Model town yamunanagar haryana 135001
Yamunanagar
HARYANA
131301
India |
| Phone |
09416060126 |
| Fax |
|
| Email |
lakshayssainis@gmail.com |
|
|
Source of Monetary or Material Support
|
| J.N Kapoor DAV (c) Dental College Yamunanagar, Haryana Pin Code -135001 |
|
|
Primary Sponsor
|
| Name |
J.N Kapoor DAV (c) Dental College |
| Address |
Model town yaamunanagar haryana 135001 |
| Type of Sponsor |
Other [Private Dental 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 Lakshay saini |
J.N Kapoor DAV (c) Dental college Yamunanagar |
Model town yamunanagar 135001
Yamunanagar
HARYANA |
09416060126
lakshayssainis@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Edentulous Patients |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
LLLT(Low Level Laser Therapy) |
Low-level laser therapy with a
wavelength of 810nm wavelength, a measured power output of 50mW and a spot size
of 0.4cm2 will be applied in six points (80 s each point of application; energy density=11
J/cm2) prior to the preparation of the bone bed. After suturing, Low-level laser therapy (LLLT) will be applied at same points again. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with age group greater than equals to 21years.
2. Patients should have at least one healed edentulous site in mandible.
3. Patients should have adequate bone dimensions for implant placement without
the need for guided bone regeneration procedure.
4. The insertion torque 30 to 60 N.cm
5. Patients should be systemically healthy.
6. Patients who are willing and available for recall and follow-ups.
|
|
| ExclusionCriteria |
| Details |
1. Patients with uncontrolled systemic diseases, pregnant and lactating women.
2. Patients who are current/ex-smoker or consume any other form of tobacco.
3. Patients who need advanced surgical procedure for implant placement
4. Patients have history of radiation therapy in the head and neck region. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) RFA (Resonance Frequency Analysis) to measure Implant Stability.
2) Radiographic evaluation. |
1) RFA (Resonance Frequency Analysis) to measure Implant Stability- at baseline, 2 weeks,4 weeks,8 weeks,12 weeks
2) Radiographic evaluation-at baseline,3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
secondary outcome
1) Plaque index (PI)
2) Gingival index (GI) |
1) Plaque index (PI)-at baseline,3 months
2) Gingival index (GI)-at baseline,3 months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 4 |
|
Date of First Enrollment (India)
|
20/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/01/2026 |
| 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)
|
Open to Recruitment |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 22-06-2025 and end date provided 22-06-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
RESEARCH QUESTION Whether Low Level Laser Therapy (LLLT) using 810nm diode laser is effective in enhancing the stability (ISQ values) of implants placed in partially edentulous mandibular sites measured by means of Resonance Frequency Analysis (RFA).
AIM: To evaluate the effectiveness of Low Level Laser Therapy (LLLT) using 810nm diode laser on implant stability measured by Resonance Frequency Analysis (RFA)
OBJECTIVES: 1. To determine the stability of implants placed by conventional method without Low Level Laser Therapy (LLLT) using Resonance Frequency Analysis (RFA). 2. To determine the stability of implants placed by conventional method with Low Level Laser Therapy (LLLT) using Resonance Frequency Analysis (RFA). 3. To compare the stability of implants placed conventionally with or without Low Level Laser Therapy (LLLT) using Resonance Frequency Analysis (RFA).
|