| CTRI Number |
CTRI/2024/06/069252 [Registered on: 19/06/2024] Trial Registered Prospectively |
| Last Modified On: |
18/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Medical Device
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The effects of low level laser therapy after flap surgery in patients with chronic peridodo titis |
|
Scientific Title of Study
|
Effects of Photobiomodulation with flap surgery versus flap surgery alone on wound healing and pain management: A 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 |
Akanksha A Gugale |
| Designation |
MDS Post-Graduate |
| Affiliation |
KLE VK Institute of Dental Sciences |
| Address |
Dept.9,Second floor, KLE VK Institute of Dental Sciences, JNMC Campus, Nehru Nagar, Belagavi-590010
Belgaum
KARNATAKA
590010
India |
| Phone |
08975562900 |
| Fax |
|
| Email |
gugale.akanksha796@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shruti Karvekar |
| Designation |
Lecturer |
| Affiliation |
KLE VK Institute of Dental Sciences |
| Address |
Dept.9,Second floor, KLE VK Institute of Dental Sciences, JNMC Campus, Nehru Nagar, Belagavi-590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9986155460 |
| Fax |
|
| Email |
shruti.karvekar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Akanksha A Gugale |
| Designation |
MDS Post-Graduate |
| Affiliation |
KLE VK Institute of Dental Sciences |
| Address |
Dept.9,Second floor, KLE VK Institute of Dental Sciences, JNMC Campus, Nehru Nagar, Belagavi-590010
Belgaum
KARNATAKA
590010
India |
| Phone |
08975562900 |
| Fax |
|
| Email |
gugale.akanksha796@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept.9,Second floor, KLE VK Institute of Dental Sciences, JNMC Campus, Nehru Nagar, Belagavi-590010 |
| Self |
|
|
Primary Sponsor
|
| Name |
Dr Akanksha Gugale |
| Address |
KLE VK Institute of Dental Sciences, JNMC Campus, Nehru Nagar, Belagavi-590010 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Shruti Karvekar |
KLE VK Institute of Dental Sciences, JNMC Campus, Nehru Nagar, Belagavi-590010 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Akanksha Gugale |
KLE Dental College and Hospital |
KLE VK Institute of Dental Sciences, JNMC Campus, Nehru Nagar, Belagavi-590010
Belgaum
KARNATAKA |
08975562900
gugale.akanksha796@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Research and ethics committee KLE VKIDS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K056||Periodontal disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Normal flap surgery without any photobiomodulation |
The patients in group of flap surgery alone (control group) will undergo flap procedure without any photobiomodulation. Local anesthetic will be administered using 2% lignocaine hydrochloride with 1:80,000 adrenaline in the area to be operated. The surgical procedure will involve the elevation of a mucoperiosteal flap followed by debridement and root planing. post-operative analgesics will be prescribed |
| Intervention |
Photobiomodulation using Diode Lasers |
The patients will be randomized into either the Photobiomodulation with flap surgery (test group) or flap surgery alone (control group) using the computer-assisted randomization technique. Local anesthetic will be administered using 2% lignocaine hydrochloride with 1:80,000 adrenaline in the area to be operated. The surgical procedure will involve the elevation of a mucoperiosteal flap followed by debridement and root planing. In the test group, gallium/ aluminum/arsenide (GA-AL-AS) diode laser (Novolase, Trio-blue); 980nm laser will be used. 4J/cm2 dosage will be irradiated on buccal and lingual flaps before surgery and immediately post-operatively, 1-day post-op and 3-day post-op |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Systemically healthy individuals
Subjects of age 30 – 60 years.
Subjects with probing pocket depth of ≥ 5mm after phase I therapy.
Subjects willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
Pregnant women.
Subjects consuming tobacco in any form.
Patients with a history of long-term use of antibiotics and corticosteroids
Subjects who underwent periodontal therapy in the past 6 months
Previous or current radiation therapy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Wound healing index (WHI) |
immediate post-operative, 3 days, 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain assessment |
1 to 7 days |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
01/07/2024 |
| 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
|
The patients will be randomized into
either the Photobiomodulation with flap
surgery (test group) or flap
surgery alone (control group) using the computer-assisted randomization
technique. Local anesthetic will be administered using 2% lignocaine
hydrochloride with 1:80,000 adrenaline in the area to be operated. The surgical
procedure will involve the elevation of a mucoperiosteal flap followed by
debridement and root planing. In the test group, gallium/ aluminum/arsenide
(GA-AL-AS) diode laser (Novolase, Trio-blue); 980nm laser will be used. 4J/cm2
dosage will be irradiated on buccal and lingual flaps before surgery and
immediately post-operatively, 1-day post-op and 3-day post-op. Flap closure
will be done by 3-0 black braided silk sutures.
Post–operative
anti-inflammatory drugs will be prescribed to the patient.
Patient
will be discharged after giving post-operative instructions.
Follow up will be done
for clinical parameters after 7 days.
The postoperative pain
assessment will be done through two methods: the number of capsules taken by
the patient and visual analogue scale [no pain (0) to unbearable pain (10)]
Patient will
be recalled after 7 days for suture removal. |