UMIN-CTR Clinical Trial

Basic information
Public title	Effect of Low Level Laser Therapy on wound healing and Gingival Crevicular Fluid Levels of MMP-8 following open flap debridement:A Randomized Clinical Trial
Acronym	Effect of Low Level Laser Therapy on wound healing and Gingival Crevicular Fluid levels of MMP-8 following open flap debridement:A Randomized Clinical Trial
Scientific Title	Effect of Low Level Laser Therapy on wound healing and Gingival Crevicular Fluid Levels of MMP-8 following open flap debridement:A Randomized Clinical Trial
Scientific Title:Acronym	Effect of Low Level Laser Therapy on wound healing and Gingival Crevicular Fluid levels of MMP-8 following open flap debridement:A Randomized Clinical Trial
Region	Asia(except Japan)

Condition
Condition	Low Level Laser Therapy
Classification by specialty	Dental medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	1.To evaluate the effect of low level laser therapy on wound healing following open flap debridement. 2.To evaluate the MMP-8 levels in GCF following low level laser therapy and open flap debridement
Basic objectives2	Others
Basic objectives -Others	1.To evaluate the effect of low level laser therapy on wound healing following open flap debridement. 2.To evaluate the MMP-8 levels in GCF following low level laser therapy and open flap debridement
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	1.MMP-8 levels in Gingival Crevicular Fluid. 2.Early Wound Healing Index 3.Landry Wound Healing Index
Key secondary outcomes	1.Gingival Index 2.Plaque Index 3.Pocket Probing Depth 4.Clinical Attachment Level

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Test site 1-open flap debridement with soft tissue diode laser The diode laser of 980nm ata power output of 2.5W in pulsed mode was used at baseline,3rd day and 7th day
Interventions/Control_2	Test site 2-open flap debridement only The diode laser of 980nm ata power output of 2.5W in pulsed mode was used at baseline,3rd day and 7th day
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	18 years-old <=
Age-upper limit	60 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients presenting with Chronic Periodontitis 1.Case definition as per 1999 Classification 2.Clinical Pobing Depth of more than 5mm and less than 7mm 3.Clinical attachment level of more than 4mm in atleast two adjacent sites per tooth. 4.Presence of minimum 20 teeth 5.Radiographic evidence of bone loss
Key exclusion criteria	1.Patients with systemic conditions like Diabetes melitus, hypertension, atherosclerosis and other systemic diseases known to affect periodontal status. 2.Pregnant and Lactating Women. 3.Use of hormonal contraceptives. 4.Pockets of more than 8mm in the studied area 5.Patients with deleterious habits like alcohol consumption , tobacco habits and any other adverse habits. 6 Patients who have received any surgical or non surgical periodontal therapy in past 6 months. 7.Patients who have received any antimicrobial therapy in past 6 months.
Target sample size	10

Research contact person
Last name of lead principal investigator	1st name Middle name Last name suhani goel
Organization	ITS Dental College,hospitaland research centre Knowledge Park 3 Greater Noida
Division name	Periodontics
Zip code
Address	ITS dental college, Hospital and Research Centre, KNOWLEDGE PARK 3, GREATER NOIDA-201308
TEL	9997015161
Email	drsuhanigoel@gmail.com

Public contact
1st name of contact person	1st name Middle name Last name Suhani Goel
Organization	0120- 2331083, 2331089 email id- dental.gn@its.edu.in
Division name	ITS DENTAL COLLEGE
Zip code
Address	KNOWLEDGE PARK 3
TEL	09997015161
Homepage URL
Email	drsuhanigoel@gmail.com

Sponsor
Institute	ITS Dental College,Hospital and Research centre KNOWLEDGE PARK 3 GREATER NOIDA-201308
Institute
Department

Funding Source
Organization	ITS Dental College,Hospital and Research centre KNOWLEDGE PARK 3 GREATER NOIDA-201308
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	India

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2019 Year 02 Month 09 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
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	2016 Year 10 Month 29 Day
Date of IRB
Anticipated trial start date	2016 Year 12 Month 07 Day
Last follow-up date	2018 Year 06 Month 15 Day
Date of closure to data entry	2018 Year 06 Month 15 Day
Date trial data considered complete	2018 Year 06 Month 15 Day
Date analysis concluded	2018 Year 10 Month 30 Day

Other
Other related information

Management information
Registered date	2019 Year 02 Month 09 Day
Last modified on	2019 Year 02 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040812

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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