| CTRI Number |
CTRI/2024/08/072894 [Registered on: 22/08/2024] Trial Registered Prospectively |
| Last Modified On: |
22/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
"Randomized Controlled Trial on Photobiomodulation with CO2 and Diode Lasers: Impact on Implant Stability, Post-Surgical Healing, and Inflammation in Dental Patients" |
|
Scientific Title of Study
|
Comparative Evaluation Of The Implant Stability, Post-surgical Healing And Inflammation By Photobiomodulation Using CO2 Laser And Diode Laser: Randomized 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 |
HAGE YAKANG |
| Designation |
post graduate students |
| Affiliation |
Government dental college and hospital |
| Address |
Government Dental College and Hospital, Nagpur. Address Medical College Premises, Medical Square , Nagpur , Maharashtra 440003
202 DEPARTMENT OF PERIODONTOLOGY, GOVERNMENT OF DENTAL COLLEGE AND HOSPITAL NAGPUR.
Nagpur
MAHARASHTRA
440003
India |
| Phone |
08413060310 |
| Fax |
|
| Email |
hageyakang97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
HAGE YAKANG |
| Designation |
post graduate students |
| Affiliation |
Government dental college and hospital |
| Address |
Government Dental College and Hospital, Nagpur. Address Medical College Premises, Medical Square , Nagpur , Maharashtra 440003
202 DEPARTMENT OF PERIODONTOLOGY, GOVERNMENT OF DENTAL COLLEGE AND HOSPITAL , NAGPUR
Nagpur
MAHARASHTRA
440003
India |
| Phone |
08413060310 |
| Fax |
|
| Email |
hageyakang97@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaibhav Karemore |
| Designation |
Associate Professor |
| Affiliation |
Government dental college and hospital |
| Address |
Department Of Periodontology,Government Dental College and Hospital, Nagpur. Address Medical College Premises, Medical Square , Nagpur , Maharashtra 440003
Department of Periodontollogy Government Dental College and Hospital, Nagpur. Address Medical College Premises, Medical Square , Nagpur , Maharashtra 440003
Nagpur
MAHARASHTRA
440003
India |
| Phone |
9011098882 |
| Fax |
|
| Email |
drperiodon@gmail.com |
|
|
Source of Monetary or Material Support
|
| Deparment of Periodontology Government Dental College and Hospital, Nagpur. Address Medical College Premises, Medical Square , Nagpur , Maharashtra 440003 |
|
|
Primary Sponsor
|
| Name |
HAGE YAKANG |
| Address |
Government Dental College and Hospital, Nagpur. Address Medical College Premises, Medical Square , Nagpur , Maharashtra 440003 |
| Type of Sponsor |
Other [self funded] |
|
|
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 Yakang Hage |
Government Dental College and Hospital Nagpur |
202, DEPARTMENT OF PERIODONTOLOGY, GOVERNMENT OF DENTAL COLLEGE AND HOSPITAL NAGPUR
Nagpur
MAHARASHTRA |
08413060310
hageyakang97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Dental College and Hospital, Nagpur. Address Medical College Premises, Medical Square , Nagpur , Maharashtra |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Implants will be placed without photobiomodulation to the implants. |
after explaining the study to the patients, an informed consent will be taken from the patient before the study.
Implants will be placed without photobiomodulation to the implants. |
| Intervention |
Patients receiving CO 2 laser photobiomodulation during implant surgery.
|
after explaining the study to the patients, an informed consent will be taken from the patient before the study.
In test group 1, patients will receive intraoral CO2 irradiation for 30 through a handpiece that will enter contact with the mucosa and which will be positioned to allow light to enter perpendicularly to the longitudinal axe of the dental implant at 3mm from the bone crest.
2. Three points will be irradiated: the buccal side and the palatal or lingual side using the CO2 laser, to stimulate bone tissue regeneration; and the occlusal side, to stimulate mucosal tissue regeneration and anti-inflammatory effect.
3. The laser treatment will repeat 10 days later after suture removal.
|
| Intervention |
Patients receiving Diode laser photobiomodulation during implant surgery. |
after explaining the study to the patients, an informed consent will be taken from the patient before the study.
1. In test group 2, patients will receive intraoral diode laser irradiation for 30s through a handpiece that will enter contact with the mucosa and which will be positioned to allow light to enter perpendicularly to the longitudinal axe of the dental implant at 3mm from the bone crest immediately after implant placement. 2. Three points will be irradiated: the buccal side and the palatal or lingual side using the diode laser, to stimulate bone tissue regeneration; and the occlusal side, to stimulate mucosal tissue regeneration and anti-inflammatory effect. 3. laser treatment will repeat 10 days later after suture removal.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients above 18 years of age.
2) Patients who opt for dental implant surgery for a missing tooth.
3) Thin biotype
4) Patient with healthy systemic condition.
5) Adequate oral hygiene levels.
|
|
| ExclusionCriteria |
| Details |
1. Patients with systemic diseases that contraindicate the surgery, immune-compromised patients.
2. Patients with implant sites that presented complications.
3. Pregnant or lactating females.
4. Patients not willing to participate in the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary outcomes measured will be implant stability, post-surgical healing, and inflammation. Implant stability will be assessed using resonance frequency analysis. Healing will be evaluated through clinical assessments using the Landry healing index, and inflammation will be measured by clinical signs and potentially biochemical markers in peri-implant crevicular fluid.
This methodological structure allows the study to rigorously test the efficacy of two different types of lasers in improving the clinical outcomes of dental implants, providing clear insights into which modality might be more effective or if photobiomodulation offers significant benefits over traditional implant procedures without such interventions.
|
T0 at baseline period
T1 at 10 days
T2 at 4 weeks
T3 at 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
This methodological structure allows the study to rigorously test the efficacy of two different types of lasers in improving the clinical outcomes of dental implants, providing clear insights into which modality might be more effective or if photobiomodulation offers significant benefits over traditional implant procedures without such interventions.
|
T0 at baseline period
T1 at 10 days
T2 at 4 weeks
T3 at 3 months |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
10/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/09/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
title of my proposed study, is “Comparative Evaluation of the Implant
Stability, Post-Surgical Healing and Inflammation by Photobiomodulation using
CO2 Laser and Diode Laser: Randomized Controlled Trialâ€. This research is
particularly novel because it compares two different lasers that enhance implant stability and accelerate
post-surgical healing. This would not only improve patient outcomes but also
potentially reduce the incidence of peri-implantitis and other complications
associated with dental implants. Additionally, this study’s findings will
contribute to a better understanding of the biological mechanisms involved in
osseointegration and tissue repair, further benefiting the field and enhancing
the scientific promotion of implant treatment methodologies. |