UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039770 |
|---|---|
| Receipt number | R000045311 |
| Scientific Title | Effect of Low Level Laser Therapy on Wound Healing and Levels of Osteoprotegerin (OPG) In Gingival crevicular fluid following Open Flap Debridement: A Randomized Controlled Clinical Trial |
| Date of disclosure of the study information | 2020/03/12 |
| Last modified on | 2020/03/11 14:35:35 |
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Basic information
Public title
Effect of Low Level Laser Therapy on Wound Healing and Levels of Osteoprotegerin (OPG) In Gingival crevicular fluid following Open Flap Debridement: A Randomized Controlled Clinical Trial
Acronym
Effect of Low Level Laser Therapy on Wound Healing and Levels of Osteoprotegerin (OPG) In Gingival crevicular fluid following Open Flap Debridement: A Randomized Controlled Clinical Trial
Scientific Title
Effect of Low Level Laser Therapy on Wound Healing and Levels of Osteoprotegerin (OPG) In Gingival crevicular fluid following Open Flap Debridement: A Randomized Controlled Clinical Trial
Scientific Title:Acronym
Effect of Low Level Laser Therapy on Wound Healing and Levels of Osteoprotegerin (OPG) In Gingival crevicular fluid following Open Flap Debridement: A Randomized Controlled Clinical Trial
Region
| Asia(except Japan) |
Condition
Condition
Periodontitis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of low level laser therapy on wound healing and OPG levels following open flap debridement
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Decrease in clinical parameters following low level laser therapy and more increase in osteoprotegerin levels on laser treated site
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Arm 1: Open flap debridement with Low level laser therapy at baseline, 3 months and 6 months
0.8-1.2 watt for 3 cycles/10 seconds
duration: 3 cycles/10 seconds each cycle
Interventions/Control_2
arm 2: Open flap debridement only
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients with chronic periodontitis
presence of atleast 20 permanent teeth
clinical probing depth more than or equal to 5 mm and less than 8 mm post phase 1 therapy
Key exclusion criteria
pregnant and lactating women
patient allergic to medications
patient with systemic disease
smokers
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Subarbie |
| Middle name | |
| Last name | Abrol |
Organization
ITS DENTAL COLLEGE
Division name
GREATER NOIDA
Zip code
201308
Address
Knowledge park 3, Gautam Buddha Nagar, Uttar Pradesh
TEL
8826199391
subarbieabrol@gmail.com
Public contact
Name of contact person
| 1st name | Shivjot |
| Middle name | |
| Last name | Chhina |
Organization
ITS Dental College
Division name
Greater Noida
Zip code
201308
Address
knowledge park 3, Greater Noida
TEL
9811787808
Homepage URL
hod.perio.gn@its.edu.in
Sponsor or person
Institute
ITS Dental college, Greater Noida
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
ITS dental college
Address
knowledge park 3 , Greater Noida
Tel
8826199391
subarbieabrol@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
10
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 06 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 11 | Day |
Last modified on
| 2020 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045311
