| CTRI Number |
CTRI/2025/11/097064 [Registered on: 07/11/2025] Trial Registered Prospectively |
| Last Modified On: |
05/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia Dentistry Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Low Intensity Pulsed Ultrasound Therapy on Dental Implant Stability and Bone Healing |
|
Scientific Title of Study
|
A Prospective Randomised Controlled Study To Evaluate The Impact Of Low Intensity Pulsed Ultrasound(LIPUS) Threapy On Osseointegration,Primary Stability And PEiimplant bone Quality in Dental implant Patients |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rohan Diyya |
| Designation |
Post graduate Trainee |
| Affiliation |
Meenakshi Ammal Dental College and Hospital |
| Address |
Alapakkam Mian RD,Janaki Nagar,Maduravoyal,Thiruvallur,TAmil Nadu. Alapakkam Mian RD,Janaki Nagar,Maduravoyal,Thiruvallur,TAmil Nadu,600095 Thiruvallur TAMIL NADU 600095 India |
| Phone |
9490575151 |
| Fax |
|
| Email |
diyya.rohan@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Rohan Di |
| Designation |
Post graduate Trainee |
| Affiliation |
Meenakshi Ammal Dental College and Hospital |
| Address |
Alapakkam Mian RD,Janaki Nagar,Maduravoyal,Thiruvallur,TAmil Nadu. Alapakkam Mian RD,Janaki Nagar,Maduravoyal,Thiruvallur,TAmil Nadu,600095 Thiruvallur TAMIL NADU 600095 India |
| Phone |
9490575151 |
| Fax |
|
| Email |
diyya.rohan@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Rohan Di |
| Designation |
Post graduate Trainee |
| Affiliation |
Meenakshi Ammal Dental College and Hospital |
| Address |
Alapakkam Mian RD,Janaki Nagar,Maduravoyal,Thiruvallur,TAmil Nadu. Alapakkam Mian RD,Janaki Nagar,Maduravoyal,Thiruvallur,TAmil Nadu,600095 Thiruvallur TAMIL NADU 600095 India |
| Phone |
9490575151 |
| Fax |
|
| Email |
diyya.rohan@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Meenakshi ammal Dental College and Hospital |
| Address |
Alapakkam Main Rd,Janaki Nagar,Maduravoyal,Thiruvallur,TAmil Nadu,600095 |
| 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 |
| Rohan Diyya |
Meenakshi Ammal Dental College and Hospiital |
Alapakkam main rd,Janaki nagar,MAduravoyal,Chennai Thiruvallur TAMIL NADU |
9490575151
diyya.rohan@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 |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged between 20 and 40 years
Patients requiring a dental implants
Adequate bone height and width as assessed clinically and radiologically
Healthy, non-smoking individuals
Patients willing to comply with the study protocol and follow-up visits |
|
| ExclusionCriteria |
| Details |
Patients with systemic diseases that could affect bone healing
Patients with a history of radiation therapy in the head and neck region
Patients with poor oral hygiene or active periodontal disease
Patients with any condition that contraindicates dental implant surgery
5.Pregnant or lactating women.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Implant Stability Quotient (ISQ) values via RFA
Insertion and removal torque values
Marginal bone level changes via CBCT |
Implant Stability Quotient (ISQ) values via RFA
Insertion and removal torque values
Marginal bone level changes via CBCT |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
02/01/2026 |
| 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="11" Days="28" |
|
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
|
The research addresses the critical role of osseointegration a direct bone and implant interface—in the success of dental implants It explores how LIPUS a noninvasive therapy using acoustic energy may accelerate bone healing and improve implant stability by stimulating osteogenic cell activity and enhancing bone quality around implants This prospective randomized controlled trial includes 22 patients aged 20 to 40 who require single dental implants Patients are randomized into two groups one receives LIPUS therapy twice weekly for 20 minutes starting one week post surgery for three weeks while the control group undergoes standard care without LIPUS Outcomes are assessed using resonance frequency analysis insertion torque measurements and cone beam computed tomography CBCT imaging to monitor implant stability peri implant bone densityvand marginal bone loss at baseline 3 months and 6 monthsvPrevious studies cited in the thesis suggest that LIPUS can enhance bone formation decrease healing time and minimize crestal bone loss without adverse effects The study aims to provide robust clinical evidence for LIPUS as an adjunct treatment to improve the success rates of dental implants potentially transforming post operative care by enabling faster recovery and better implant integration Ethical considerations patient selection criteria study methodology and statistical plans are thoroughly outlined to ensure rigorous evaluation of the techniques efficacy and safety Overall the thesis positions LIPUS therapy as a promising innovation in oral and maxillofacial surgery to optimize implant outcomes and patient quality of life |