| CTRI Number |
CTRI/2026/02/103272 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
06/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Assessment of bone activity around dental implants placed in type 2 Diabetes Mellitus patients after giving them ultrasound(LIPUS) therapy |
|
Scientific Title of Study
|
Assessment of osteoblastic activity around dental implants following Low-Intensity Pulsed Ultrasound (LIPUS) therapy in patients with type 2 Diabetes Mellitus: A split-mouth randomised 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 |
Sarvesh Kulkarni |
| Designation |
Post Graduate Student |
| Affiliation |
Sri Ramachandra Dental College and Hospital |
| Address |
Department of Prosthodontics, Sri Ramachandra Dental College and Hospital, Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), No.1 Ramachandra Nagar Porur, Chennai - 600116
Tamil Nadu, India.
Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), No.1 Ramachandra Nagar Porur, Chennai - 600116 Tamil Nadu, India.
Chennai
TAMIL NADU
600116
India |
| Phone |
8888284839 |
| Fax |
|
| Email |
d0323003@sriher.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
N. Shanmuganathan |
| Designation |
Professor and Head of Department |
| Affiliation |
Sri Ramachandra Dental College and Hospital |
| Address |
Department of Prosthodontics, Sri Ramachandra Dental College and Hospital, Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), No.1 Ramachandra Nagar Porur, Chennai - 600116
Tamil Nadu, India.
Sri Ramachandra Institute of Higher Education and Research (Deemed to be University),
No.1 Ramachandra Nagar
Porur, Chennai - 600116
Tamil Nadu, India.
Chennai
TAMIL NADU
600116
India |
| Phone |
9840231829 |
| Fax |
|
| Email |
shanmuganathan.n@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Sarvesh Kulkarni |
| Designation |
Post Graduate Student |
| Affiliation |
Sri Ramachandra Dental College and Hospital |
| Address |
Department of Prosthodontics, Sri Ramachandra Dental College and Hospital, Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), No.1 Ramachandra Nagar Porur, Chennai - 600116
Tamil Nadu, India.
Sri Ramachandra Institute of Higher Education and Research (Deemed to be University),
No.1 Ramachandra Nagar
Porur, Chennai - 600116
Tamil Nadu, India.
Chennai
TAMIL NADU
600116
India |
| Phone |
8888284839 |
| Fax |
|
| Email |
d0323003@sriher.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of Prosthodontics, Sri Ramachandra Dental College and Hospital, SRIHER |
| Sarvesh Kulkarni |
|
|
Primary Sponsor
|
| Name |
Sarvesh Kulkarni |
| Address |
Department of Prosthodontics, Sri Ramachandra Dental College and Hospital, Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), No.1 Ramachandra Nagar Porur, Chennai, PIN code - 600116, Tamil Nadu, 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 N Shanmuganathan |
Sri Ramachandra Dental College and Hospital |
Department of Prosthodontics, Sri Ramachandra Dental College and Hospital, Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), No.1 Ramachandra Nagar Porur, Chennai - 600116
Tamil Nadu, India.
Chennai
TAMIL NADU |
9840231829
shanmuganathan.n@sriramachandra.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee for students projects |
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 |
Low Intensity Pulsed Ultrasound(LIPUS) therapy |
Low-Intensity Pulsed Ultrasound (LIPUS) therapy will be applied to the experimental implant site following implant placement. LIPUS will be administered for 20 minutes per session. The first session will be given on the 7th postoperative day after suture removal, followed by a second session after 3 days, and the third and fourth sessions will be completed in the subsequent week. Osteoblastic activity around the implant site will be evaluated using bone scintigraphy at 30, 60, and 90 days and alkaline phosphatase (ALP) levels at 30 and 90 days. |
| Comparator Agent |
Placebo |
The control implant site will not receive Low-Intensity Pulsed Ultrasound (LIPUS) therapy following implant placement. All surgical and postoperative procedures will be identical to the intervention site except for the application of LIPUS. Osteoblastic activity around the implant site will be evaluated using bone scintigraphy at 30, 60, and 90 days and alkaline phosphatase (ALP) levels at 30 and 90 days. |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Partially edentulous participants with bilaterally missing mandibular posterior teeth willing for implant-supported prosthesis.
2. Patients aged between 21 to 60 years.
3. Patients with Controlled Type 2 Diabetes Mellitus (HbA1c level 5.7 to 8%).
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To asses the osteoblastic activity around dental implants in patients with Type 2 Diabetes Mellitus using bone scintigraphy
|
30 days, 60 days, 90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To asses the osteoblastic activity around dental implants in patients with Type 2 Diabetes Mellitus using Alkaline phosphatase (ALP) assay. |
30 days, 90 days |
| To asses the Patient Related Outcome Measures (PROMs) regarding the LIPUS therapy using Visual Analog Scale (VAS). |
|
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
12/03/2026 |
| 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="0"
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
|
Diabetes mellitus was once considered a contraindication to the use of dental implant therapy, as it has been associated with comorbidities, including increased susceptibility to infection, impaired wound healing, and periodontitis. Since dental implants and techniques for controlling diabetes have evolved, dental implant therapy has become increasingly common among patients with Type 2 Diabetes Mellitus. The rising success of dental implants in prosthodontic rehabilitation has shifted current trends to accommodate Dental Implant placement in patients with controlled Type 2 Diabetes Mellitus. With advancements in implant surface treatment technology, Type 2 Diabetes Mellitus with well-controlled blood glucose levels is no longer considered an absolute contraindication for implant surgery. However, several studies have reported that patients with these diseases still pose a potentially high risk of implant failure. Various studies have indicated that patients with Type 2 diabetes mellitus exhibit diminished proliferation and osteogenic differentiation capabilities of osteoblasts compared to individuals without Type 2 diabetes mellitus. Also, elevated blood glucose levels can significantly impact bone tissue remodeling and interfere with the bonding between implants and bone, particularly within the first three weeks following implant placement. Literature suggests various methods to improve osseointegration around Dental Implants in patients with Type 2 Diabetes Mellitus, however effective and simple methods to enhance the osseointegration around Dental Implants are yet to be found. Abdulhameed et al. suggested a simple and effective method known as Low-Intensity Pulsed Ultrasound (LIPUS) therapy for effectively enhancing implant osseointegration and reduced healing duration. Low-Intensity Pulsed Ultrasound (LIPUS) is a noninvasive therapy that harnesses acoustic pulsed energy to provide physical stimulation. The use of LIPUS (Low-Intensity Pulsed Ultrasound Stimulation) has been shown to have a stimulatory effect on bone regeneration and osseointegration around dental implants. |