| CTRI Number |
CTRI/2024/12/078406 [Registered on: 20/12/2024] Trial Registered Prospectively |
| Last Modified On: |
18/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of low level laser treatment on dental implants |
|
Scientific Title of Study
|
EVALUATION OF EFFECT OF PHOTO BIOMODULATION WITH LOW LEVEL LASER THERAPY AND HISTO MORPHOMETRIC ANALYSIS AROUND DENTAL IMPLANTS |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VANAPAMALA GNANA KUSUMANJALI |
| Designation |
post graduate student |
| Affiliation |
St. Joseph dental college |
| Address |
Department of periodontics, st joseph dental college, duggirala, eluru.
West Godavari
ANDHRA PRADESH
533403
India |
| Phone |
09493650695 |
| Fax |
|
| Email |
anjalivanapamala@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P Aravind kumar |
| Designation |
HOD |
| Affiliation |
St. Joseph dental college |
| Address |
Department of periodontics, St joseph dental college, duggirala, eluru.
West Godavari
ANDHRA PRADESH
533403
India |
| Phone |
9948544799 |
| Fax |
|
| Email |
pavuluriak@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr P Aravind kumar |
| Designation |
HOD |
| Affiliation |
St. Joseph dental college |
| Address |
Department of periodontics, St joseph dental college, duggirala, eluru.
ANDHRA PRADESH
533403
India |
| Phone |
9948544799 |
| Fax |
|
| Email |
pavuluriak@gmail.com |
|
|
Source of Monetary or Material Support
|
| st joseph dental college, duggirala,eluru, andhra pradesh, India, 534003 |
|
|
Primary Sponsor
|
| Name |
Vanapamala Gnana kusumanjali |
| Address |
Department of Periodontics, St Joseph Dental College, Duggirala, Eluru, Andhra Pradesh, 534003. |
| Type of Sponsor |
Private medical 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 Vanapamala Gnana Kusumanjali |
St joseph dental college |
Department of periodontics, room number 8, St joseph dental college, duggirala, eluru.
West Godavari
ANDHRA PRADESH |
09493650695
anjalivanapamala@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe, St Joseph dental college & hospital, duggirala, eluru, west godavari district, Andhra pradesh. |
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 |
| Intervention |
low level laser |
low level laser will be applied during initial osteotomy and bone morphology using sem analysis and elemental analysis using EDX will be analysed |
| Comparator Agent |
not applicable |
bone morphology using sem analysis and elemental analysis using EDX will be analysed without exposing to low level laser during initial osteotomy |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Implants in Partially/ Completely edentulous sites in maxilla or mandible.
Good systemic health |
|
| ExclusionCriteria |
| Details |
Any systemic disease that affects the periodontium were contraindicated for implant placement.
Inability or unwillingness to complete the trial.
Patients on any medication that could affect or alter the course of periodontal treatment.
Poor oral hygiene.
• Pregnant, Lactating mothers.
• History of smoking and alcohol abuse.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Scanning Electron Microscopic Analysis
Energy-Dispersive X-ray Spectroscopy |
Scanning Electron Microscopic Analysis at baseline and at 6months
Energy-Dispersive X-ray Spectroscopy at baseline and at 6months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
implant stability using resonance frequency analysis
pain scale |
Resonance frequency analysis at baseline & at 6months.
pain scale at baseline & after 10 days |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
02/01/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
02/01/2025 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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 - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - nil
- For how long will this data be available start date provided 02-11-2024 and end date provided 02-11-2029?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
This study aimed to evaluate the effect of photobiomodulation by low level laser therapy and histomorphometric analysis in dental implants. The current study is a double-masked, randomized clinical trial. A total of 28 patients of age 25 to 55 years were assigned randomly into two groups. Group I: 14 osteotomy sites were treated with low level laser. Group B: 14 Osteotomy sites were not treated with low level laser. bone samples were collected using trephine drill during initial osteotomy and during 2nd stage of implant and samples will be subjected to SEM analysis to know bony architecture and EDX analysis will be done for calcium and phosphorous analysis. Implant stability will be measured by using Penguin RFA device. |