UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031087 |
|---|---|
| Receipt number | R000035502 |
| Scientific Title | Comparative evaluation of Laser Bio-Stimulation as an adjunct to Non-Surgical Periodontal Therapy and its effects on Aspartate Aminotransferase levels in the management of Chronic Periodontitis-A Randomized Controlled Trial |
| Date of disclosure of the study information | 2018/01/31 |
| Last modified on | 2018/02/01 12:58:50 |
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Basic information
Public title
Comparative evaluation of Laser Bio-Stimulation as an adjunct to Non-Surgical Periodontal Therapy and its effects on Aspartate Aminotransferase levels in the management of Chronic Periodontitis-A Randomized Controlled Trial
Acronym
Comparative evaluation of Laser Bio-Stimulation as an adjunct to Non-Surgical Periodontal Therapy and its effects on Aspartate Aminotransferase levels in the management of Chronic Periodontitis-A Randomized Controlled Trial
Scientific Title
Comparative evaluation of Laser Bio-Stimulation as an adjunct to Non-Surgical Periodontal Therapy and its effects on Aspartate Aminotransferase levels in the management of Chronic Periodontitis-A Randomized Controlled Trial
Scientific Title:Acronym
Comparative evaluation of Laser Bio-Stimulation as an adjunct to Non-Surgical Periodontal Therapy and its effects on Aspartate Aminotransferase levels in the management of Chronic Periodontitis-A Randomized Controlled Trial
Region
| Asia(except Japan) |
Condition
Condition
Chronic Generalized Periodontitis
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1.To evaluate and compare the effects on Aspartate Aminotransferase levels in GCF following non-surgical periodontal therapy with and without Laser Biostimulation.
2.To evaluate and comapare the effects on Aspartate Aminotransferase levels in GCF following non surgical periodontal therapy with and without Laser Biostimulation on clinical parameters.
Basic objectives2
Others
Basic objectives -Others
Clinical evaluation of soft tissue diode laser as an adjunct to Non surgical periodontal therapy and evaluation of Aspartate Aminotransferase in gingival crevicular fluid .
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
Laser Biostimulation along with Scaling and Root Planing has shown promising results on clinical and biochemical marker evaluation.
Key secondary outcomes
Laser Biostimulation along with Scaling and Root Planing has shown promising results on clinical and biochemical marker evaluation.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Procedure for laser irradiation The diode laser of 980 nm at a power output of 2.5 W in pulsed mode was used. The tip of the fiber was inserted into the pocket.Each site was radiated for 30 seconds twice with 60 seconds interval.
Interventions/Control_2
Scaling and root planing alone
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Case definition as per AAP classification1999.
Clinical probing depth 5mm - 7mm
Clinical attachment loss atleast 4 mm in at least 2 adjacent sites per tooth
Presence of minimum 20 teeth.
Radiographic evidence of bone loss.
Key exclusion criteria
Patients with systemic conditions like Diabetes, hypertension, atherosclerosis and other systemic diseases known to affect periodontal status.
Pregnant LactatingWomen.
Use of hormonal contraceptives
Pockets of more than 8mm in the studied area
Patients with deleterious habits like alcohol consumption , tobacco habits and any other adverse habits.
Patients who have received any surgical or non surgical periodontal therapy in past 6 mo nt hs.
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 | Dr Stuti Gupta |
Organization
ITS DENTAL COLLEGE,HOSPITAL AND RESEARCH CENTRE
Division name
KNOWLEDGE PARK 3
Zip code
Address
Gautam buddh nagar,Uttar Pradesh,India,201308
TEL
9953742797
Stutigupta0901@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Dr Stuti Gupta |
Organization
ITS DENTAL COLLEGE,HOSPITAL AND RESEARCH CENTRE
Division name
Knowledge Park 3
Zip code
Address
Gautam buddh nagar,Uttar Pradesh,India,201308
TEL
9953742797
Homepage URL
Stutigupta0901@gmail.com
Sponsor or person
Institute
ITS DENTAL COLLEGE HOSPITAL AND RESEARCH CENTRE GREATER NOIDA,UTTAR PRADESH
Institute
Department
Personal name
Funding Source
Organization
ITS DENTAL COLLEGE,HOSPITAL AND RESEARCH CENTRE,knowledge park 3,Gautam Buddh Nagar,Uttar Pradesh,201308
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Indian
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
ITS DENTAL COLLEGE,HOSPITAL AND RESEARCH CENTRE,knowledge park 3,Gautam Buddh Nagar,Uttar Pradesh,201308
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 31 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 11 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 23 | Day |
Last follow-up date
| 2017 | Year | 09 | Month | 15 | Day |
Date of closure to data entry
| 2017 | Year | 09 | Month | 15 | Day |
Date trial data considered complete
| 2017 | Year | 09 | Month | 15 | Day |
Date analysis concluded
| 2017 | Year | 09 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 31 | Day |
Last modified on
| 2018 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035502
| Research Plan | |
|---|---|
| Registered date | File name |
| 2018/01/31 | 931DD779-7F54-4938-A8A6-7FFA2629479F.jpeg |
| Research case data specifications | |
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| Registered date | File name |
| 2018/01/31 | B0254BF7-B544-429D-A7F3-C48D6063B509.jpeg |
| Research case data | |
|---|---|
| Registered date | File name |
| 2018/01/31 | 2CC79B23-9642-4989-BC64-EBC717C48C59.jpeg |
