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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032428
Receipt No. R000036980
Scientific Title EFFECT OF 1% ALENDRONATE GEL ON IL-6 LEVELS IN NON-SURGICAL MANAGEMENT OF CHRONIC PERIODONTITIS - A CLINICAL TRIAL & A BIOCHEMICAL ANALYSIS
Date of disclosure of the study information 2018/04/30
Last modified on 2018/04/30

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Basic information
Public title EFFECT OF 1% ALENDRONATE GEL ON IL-6 LEVELS IN NON-SURGICAL MANAGEMENT OF CHRONIC PERIODONTITIS - A CLINICAL TRIAL & A BIOCHEMICAL ANALYSIS
Acronym 1% Alendronate Gel in Chronic Periodontitis
Scientific Title EFFECT OF 1% ALENDRONATE GEL ON IL-6 LEVELS IN NON-SURGICAL MANAGEMENT OF CHRONIC PERIODONTITIS - A CLINICAL TRIAL & A BIOCHEMICAL ANALYSIS
Scientific Title:Acronym 1% Alendronate Gel in Chronic Periodontitis
Region
Asia(except Japan)

Condition
Condition Generalized Chronic Periodontitis
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To find out the effect of 1% Alendronate gel on levels of IL-6 in non-surgical management of Chronic Periodontitis.
To compare and evaluate the effect of 1% Alendronate Gel on clinical parameters.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II,III

Assessment
Primary outcomes In the present study the results showed statistically significant reduction in pocket probing depths (P < 0.001) and relative attachment gain (P < 0.001) at treated sites from baseline to 6 months. Similarly, there was a statistical significant reduction in IL-6 level in GCF at the treated site (P < 0.001).
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 1% Alendronate Gel
Interventions/Control_2
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
21 years-old <=
Age-upper limit
45 years-old >=
Gender Male and Female
Key inclusion criteria Chronic Periodontitis patients as per AAP classification of 1999 with PD 5mm to 7 mm.
Radiographic evidence of horizontal bone loss.
No history of periodontal therapy 6 months prior to the study.
No usage of antibiotics in the preceding 6 months of the study.
Key exclusion criteria Allergy to ALN/Bisphosphonate group of drugs.
Systemic ALN/Bisphosphonate group of drugs therapy.
Patients suffering from Aggressive Periodontitis.
Smokers and tobacco chewers.
Alcoholics.
Immunocompromised patients.
Pregnant or lactating females.
Radiographic evidence of vertical bone loss.
Patient suffering from any inflammatory bone disease
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Dr. Shradha
Organization ITS Dental College, Hospital and Research Centre
Division name Department of Periodontics
Zip code
Address 47, Knowledge Park III, I.T.S. Dental College, Hospital and research Centre
TEL 9540846621
Email sinhashraddha30@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Shradha Shradha
Organization ITS Dental College, Hospital and Research Centre
Division name Department of Periodontics
Zip code
Address 47, Knowledge Park III, I.T.S. Dental College, Hospital and research Centre
TEL 9540846621
Homepage URL
Email sinhashraddha30@gmail.com

Sponsor
Institute ITS Dental College, Hospital and Research Centre, 47, Knowledge Park III, I.T.S. Dental College, Hospital and research Centre
Institute
Department

Funding Source
Organization ITS Dental College, Hospital and Research Centre
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Dr.

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
2018 Year 04 Month 30 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 07 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 21 Day
Last follow-up date
2017 Year 09 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 04 Month 30 Day
Last modified on
2018 Year 04 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036980

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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