| CTRI Number |
CTRI/2025/05/087369 [Registered on: 22/05/2025] Trial Registered Prospectively |
| Last Modified On: |
22/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Assessing A 660nm Diode Lasers Effectiveness In Healing Post-Extraction Wounds In Patients With Diabetes |
|
Scientific Title of Study
|
Evaluating The Efficacy Of A 660nm Diode Laser For Post Extraction Wound Healing In Diabeteic 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 |
Dr Sree Hari S |
| Designation |
Post-Graduate |
| Affiliation |
Manipal College Of Dental Sciences,Mangalore |
| Address |
Manipal College of Dental Sciences Mangalore Light house Hill road Hampankatta Mangalore
Dakshina Kannada
KARNATAKA
570051
India |
| Phone |
7012609808 |
| Fax |
|
| Email |
hari.mcodsmlr2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dharnappa Poojary |
| Designation |
Professor and Head of Department |
| Affiliation |
Manipal College Of Dental Sciences,Mangalore |
| Address |
Department of Oral & Maxillofacial Surgery; Manipal College of Dental Sciences, Mangalore, Manipal Academy of Higher Education,Manipal
Dakshina Kannada
KARNATAKA
576104
India |
| Phone |
9901725285 |
| Fax |
|
| Email |
dharnappa.poojary@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sree Hari S |
| Designation |
Post-Graduate |
| Affiliation |
Manipal College Of Dental Sciences,Mangalore |
| Address |
Manipal College of Dental Sciences Mangalore Light house Hill road Hampankatta Mangalore
Dakshina Kannada
KARNATAKA
570051
India |
| Phone |
7012609808 |
| Fax |
|
| Email |
hari.mcodsmlr2023@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| self funded,, Department of Oral & Maxillofacial Surgery, Manipal College of Dental Sciences, Mangalore, Manipal Academy of Higher Education, Manipal, Karnataka- INDIA 576104 |
|
|
Primary Sponsor
|
| Name |
Dr Sree Hari S |
| Address |
Department of Oral & Maxillofacial Surgery, Manipal College of Dental Sciences, Mangalore, Manipal Academy of Higher Education, Manipal, Karnataka- INDIA 576104 |
| 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 Sree hari |
manipal college of dental sceinces,mangalore |
Department of Oral & Maxillofacial Surgery, Manipal College of Dental Sciences, Mangalore, Manipal Academy of Higher Education, Manipal, Karnataka- INDIA 576104
Dakshina Kannada
KARNATAKA |
7012609808
sreeh298@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| instituitional ethics committee MCODS,MANGALORE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E08-E13||Diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Laser |
Application of 660nm Diode Laser on Post Extraction Socket for 120 seconds immediately after extraction,24 hours and 48 hours post extraction |
| Comparator Agent |
non laser group |
antibiotics will be given |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with diabetes among age group 45 to 65 years
Patients with teeth indicated for forceps extraction
Patients willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
Patients less than 45 years
Non diabetic patients.
Patients with other systemic conditions like hypertension, asthma, allergy.
Patients unwilling to participate in the study.
Pregnant, lactating or female subjects taking oral contraceptives.
Patients with drug allergies.
Patients who have tobacco habits.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| : To compare and assess the time duration of wound healing in diabetic patients with and without the application of 660nm diode laser. |
: To compare and assess the time duration of wound healing in diabetic patients with and without the application of 660nm diode laser on the 3rd,5th and 7th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare & assess the time duration of wound healing in diabetic patients with & without the application of 660nm diode laser. |
To compare & assess the time duration of wound healing in diabetic patients with & without the application of 660nm diode laser on 3rd,5th & 7th day |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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 |
|
Date of First Enrollment (India)
|
22/06/2025 |
| 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="2"
Months="0"
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
|
This study assesses the efficacy of 660nm diode laser for post extraction wound healing in diabetic patients in 42 patients.this study consists of group A (experimental group) will be treated with 660 nm laser and antibiotics and group B (control group) will be treated with antibiotics.the patients will be explained about the procedure and frequency of visits.extraction of teeth will be performed as atraumatic as possible.depending on the site involved,a nerve block with 2% lignocaine with adrenaline (1:100000) will be given to anaestize the corresponding region.a periosteal eleveator will be used to reflect the gingival tissue surrounding the tooth.tooth will be luxated from the socket using elevators.appropriate forceps will be used depending on the tooth to be extarcted,available tooth structure to complete the extraction process in maxilla or mandible .healing of the extraction wounds will be checked on 3rd,5th,and 7th day using landry et al healing criteria.pain willbe measured on visual analog scale (VAS) ranging from 0(no pain) to 10(most severe pain).patient informed consent will be collected before the initiation of the study. |