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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035823
Receipt No. R000040812
Official scientific title of the study 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
Date of disclosure of the study information 2019/02/09
Last modified on 2019/02/09

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Basic information
Official scientific title of the study 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
Title of the study (Brief 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
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
Name of lead principal investigator suhani goel
Organization ITS Dental College,hospitaland research centre
Knowledge Park 3
Greater Noida
Division name Periodontics
Address ITS dental college, Hospital and Research Centre, KNOWLEDGE PARK 3, GREATER NOIDA-201308
TEL 9997015161
Email drsuhanigoel@gmail.com

Public contact
Name of contact person Suhani Goel
Organization 0120- 2331083, 2331089 email id- dental.gn@its.edu.in
Division name ITS DENTAL COLLEGE
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)

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

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 10 Month 29 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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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