| CTRI Number |
CTRI/2021/02/030993 [Registered on: 04/02/2021] Trial Registered Prospectively |
| Last Modified On: |
01/02/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effectiveness of laser treatment on postoperative pain and healing of extraction socket |
|
Scientific Title of Study
|
Efficacy of Low Level Laser Therapy in the management of Post-operative Pain and Healing of Extraction socket: A Split Mouth Randomised Controlled Trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Lipika Gopal |
| Designation |
PhD Scholar |
| Affiliation |
Manav Rachna Dental college |
| Address |
Department of Oral And Maxillofacial Surgery
Room no.- QF45
Manav Rachna Dental College
Faculty of Dental Sciences
MRIIRS Sector 43 Aravalli hills Faridabad
Faridabad
HARYANA
121004
India |
| Phone |
|
| Fax |
|
| Email |
lipikagopal@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashim Aggarwal |
| Designation |
PhD Supervisor |
| Affiliation |
Manav Rachna Dental college |
| Address |
Department of Oral and Maxillofacial Surgery
MRDC
FDS
MRIIRS
Sector 43 Aravalli hills Faridabad
Faridabad
HARYANA
121004
India |
| Phone |
|
| Fax |
|
| Email |
viceprincipal.mrdc@mrei.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lipika Gopal |
| Designation |
PhD Scholar |
| Affiliation |
Manav Rachna Dental college |
| Address |
Department of Oral and Maxillofacial Surgery
Room no. - QF-45
MRDC FDS
MRIIRS Sector 43 Aravalli hills Faridabad
Faridabad
HARYANA
121004
India |
| Phone |
|
| Fax |
|
| Email |
lipikagopal@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Manav Rachna Dental College FDS MRIIRS
Faridabad |
|
|
Primary Sponsor
|
| Name |
Dr Lipika Gopal |
| Address |
Pocket L Door number 423 Sarita vihar
New Delhi
Pin code 110076 |
| Type of Sponsor |
Other [Self] |
|
|
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 Lipika Gopal |
Manav Rachna Dental College FDS MRIIRS |
Department Of Oral and Maxillofacial Surgery, Room no.-QF 45
MRDC FDS MRIIRS
Sector 43 Aravali hills Faridabad Surajkund Road Pin code 121004
Faridabad
HARYANA |
9717546141
lipikagopal@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Manav Rachna International Institute of Research and Studies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K039||Disease of hard tissues of teeth,unspecified, (2) ICD-10 Condition: R688||Other general symptoms and signs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Post extraction of teeth - normal healing |
laser therapy acting as placebo as the laser to be applied without switching it on and extraction socket to be left for normal healing. |
| Intervention |
Post extraction of teeth, low level laser therapy in the socket |
Low level laser therapy. Laser parameters will be set as follow: Wavelength 940nm, Power output 0.5W in continuous mode of operation and in defocusing mode for 90secs, while the irradiation time (exposure time of radiation) will be calculated by timer. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
a)Patients requiring extraction of permanent teeth excluding molars.
b)Systemically healthy patients with no history of diabetes, thyroid disorder, cardiovascular and respiratory disorder or any other chronic illness.
c)Patients requiring extraction for orthodontic treatment, prosthetic rehabilitation, root fractures and carious lesions without any peri-apical pathology.
d)Atraumatic extraction sites.
e)Adjacent tooth should be present either mesial or distal to the tooth to be extracted. |
|
| ExclusionCriteria |
| Details |
a) Patients with periodontally compromised teeth which requires extraction
b) Use of anti-inflammatory/analgesics 2 weeks before the study.
c) Patients with history of photosensitivities, active seizures and malignancy where laser treatment is not applicable.
d) Pregnant, postmenopausal women and lactating mothers.
e) Patients using any form of tobacco
f) Known allergy to local anesthetics
g) Patients suffering from any hormonal, hematological or any other conditions that influence bone healing. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To assess the potential role of low level laser therapy (LLLT) on soft tissue healing of extraction sockets. |
Baseline, 3days, 7days and 84days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the rate of bone formation and changes in bone density after low level laser therapy (LLLT) in post extraction socket using 3 dimensional radiographic analysis by Cone Beam Computerised tomography.
2. To compare the pain perception of patients in extraction site treated with and without low level laser therapy. |
Baseline, 3days, 7days, 84days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
15/02/2021 |
| 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="1"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The following research aims to conclude the effect of Low level laser therapy on healing of extraction socket. The study would be concluded based on calculation of soft tissue healing index clinically, pain assessment with the help of VAS scale and 3-dimensional evaluation of alveolar bone dimensional and density changes with support of Cone Beam Computerised tomography images of post extraction sites treated with low level lasers compared to contralateral control sites (without laser therapy) in the same group of patients. |