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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  
NIL 
 
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  
Name  Address 
nil   
 
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  
Status 
Approved/Obtained 
 
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

 
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