UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035823 |
|---|---|
| Receipt number | R000040812 |
| 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 |
| Date of disclosure of the study information | 2019/02/09 |
| Last modified on | 2019/02/09 14:27:58 |
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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
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
drsuhanigoel@gmail.com
Public contact
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
drsuhanigoel@gmail.com
Sponsor or person
Institute
ITS Dental College,Hospital and Research centre
KNOWLEDGE PARK 3
GREATER NOIDA-201308
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040812
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