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UMIN-CTR Clinical Trial |
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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 |
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 | |
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Condition | |||
Condition | Low Level Laser Therapy | ||
Classification by specialty |
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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 |
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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 |
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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 |
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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 |
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Age-upper limit |
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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 |
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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. |
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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 |
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 | |
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 |
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Date of disclosure of the study information |
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Progress | |||||||
Recruitment status | Completed | ||||||
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Date analysis concluded |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
URL releasing results | |
Results | |
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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 |