| CTRI Number |
CTRI/2025/11/097977 [Registered on: 24/11/2025] Trial Registered Prospectively |
| Last Modified On: |
21/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Medical Device
Surgical/Anesthesia
Diagnostic
Preventive
Screening
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing laser and ultrasound treatments for better bone strength and gum healing in people receiving dental implants |
|
Scientific Title of Study
|
Comparative evaluation of effects of low- level laser therapy and low intensity pulsed ultrasound therapy on peri-implant bone density and soft tissue healing following dental implant surgery-A clinico radiographic study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anju C |
| Designation |
Postgraduate Student |
| Affiliation |
Coorg Institute Of Dental Science |
| Address |
Coorg Institute of Dental Science,department of periodontics and implantology,room no.4, SH 88B, Kodagu Coorg District, Virajpet, Karnataka 571218
Coorg Institute of Dental Science,department of periodontics and implantology,room no.4, SH 88B, Kodagu Coorg District, Virajpet, Karnataka 571218
Kodagu
KARNATAKA
571218
India |
| Phone |
09447766337 |
| Fax |
|
| Email |
anjuc89@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anju C |
| Designation |
Postgraduate Student |
| Affiliation |
Coorg Institute Of Dental Science |
| Address |
Coorg Institute of Dental Science,department of periodontics and implantology,room no.4, SH 88B, Kodagu Coorg District, Virajpet, Karnataka 571218
Coorg Institute of Dental Science,department periodontics and implantology,room no.4, SH 88B, Kodagu Coorg District, Virajpet, Karnataka 571218
Kodagu
KARNATAKA
571218
India |
| Phone |
09447766337 |
| Fax |
|
| Email |
anjuc89@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Radhika B |
| Designation |
Professor |
| Affiliation |
Coorg Institute Of Dental Science |
| Address |
Coorg Institute of Dental Science,department of periodontics and implantology,room no.4, SH 88B, Kodagu Coorg District, Virajpet, Karnataka 571218
Coorg Institute of Dental Science,department of periodontics and implantology, rooom no.4, SH 88B, Kodagu Coorg District, Virajpet, Karnataka 571218
Kodagu
KARNATAKA
571218
India |
| Phone |
9742096982 |
| Fax |
|
| Email |
radika_b24@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Coorg Institute of Dental Science, SH 88B, Kodagu Coorg District, Virajpet, Karnataka 571218 |
|
|
Primary Sponsor
|
| Name |
Anju C |
| Address |
Coorg Institute of Dental Science,department of periodontics and Implantology, Room No.4, SH 88B, Kodagu Coorg District, Virajpet, Karnataka 571218 |
| Type of Sponsor |
Other [] |
|
|
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 |
| Anju C |
Coorg Institute Of Dental Science |
Coorg Institute of Dental Science,department of periodontics and implantology,room no.4, SH 88B, Kodagu Coorg District, Virajpet, Karnataka 571218
Kodagu
KARNATAKA |
9447766337
anjuc89@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Review Board, Coorg Institute Of Dental Science |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K069||Disorder of gingiva and edentulousalveolar ridge, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
dental titanium implant and low level laser therapy |
Measuring the peri implant bone density and soft tissue healing around the implant immediately and 3 months follow up after implant placement and adjunctive low level laser therapy application. |
| Intervention |
dental titanium implants |
Measuring the peri implant bone density and soft tissue healing around the subcrestal implants placed in edentulous region immediately and 3 months after placement. |
| Comparator Agent |
dental titanium implants and low intensity pulsed ultrasound therapy |
Measuring the peri implant bone density and soft tissue healing around the implant immediately and 3 months follow up after implant placement and adjunctive low intensity pulsed ultrasound therapy application. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients aged between 18 and 45 years, irrespective of gender
2.Presence of a single edentulous site in the posterior maxilla or mandible
3.Good oral hygiene and healthy adjacent teeth
4.Willingness to provide informed consent and adhere to study protocol
|
|
| ExclusionCriteria |
| Details |
1.Systemic conditions contraindicating implant placement (e.g., uncontrolled diabetes, immunocompromised status)
2.History of radiotherapy or any medications that may alter bone density
3.Smokers and tobacco users
4.Pregnant or lactating women
5.Patients with poor oral hygiene or untreated periodontal disease
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| increase in peri implant bone density around the implant in low intensity pulsed ultrasound group |
peri implant bone density will be assessed immediately after placement and 3 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improvement in soft tissue healing around the implants in the low level laser therapy group |
soft tissue healing will be checked immediately, and 3, 7, and 14 consecutive days. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
19/01/2026 |
| 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="0"
Months="3"
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
|
1.Rationale Dental implants are highly successful due to osseointegration. Peri implant soft tissue healing protects long term implant health. To enhance healing, low level laser therapy and low intensity pulsed ultrasound therapy offer non invasive options. Low level laser therapy of 500 to 1200nm light stimulates angiogenesis, and osteoblastic function thereby accelerating bone remodelling and implant stability. Low intensity pulsed ultrasound therapy of 30 to 100 mw per centimeter square activates mechanotransduction, increasing growth factors and osteogenic genes .So adjuctive methods like LLLT and LIPUS can improve bone regeneration and implant stabilty. 2 .Objective To evaluate and compare effect of LLLT and LIPUS on peri implant bone density and soft tissue healing. 3. Method Implant placement will be done under local anesthesia. Sites will be randomly assigned into 3 groups. Group A will be control group .Group B will be LLLT group with 940nm,100mW,356mW Per centimetersuare.Application will be immediately,3,7and 14 days after implant placement and 10 seconds per session.Group c will be LIPUS group with 1 MHZ,20mW and 100 mW per centimetersquare.Application will be 15 minute per session and twice weekely of 8 sessions.Follow up will be done after 3 months to assess peri implant bone density and soft tissue healing.Bone density will be assessed by CBCT in SIDEXIS software version 2.0.Soft tissue healing will be assessed by Langer’s healing index. 4. Expected outcome Peri implant bone density will be increased in LIPUS group and soft tissue healing will be increased in LLLT group.
|