UMIN-CTR Clinical Trial

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
Email	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
Email	hod.perio.gn@its.edu.in

Sponsor
Institute	ITS Dental college, Greater Noida
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045311