UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032428 |
|---|---|
| Receipt number | R000036980 |
| Scientific Title | Effect Of 1% Alendronate Gel as a Local Host Modulating Agent on IL-6 Levels in GCF in Non-Surgical Management of Chronic Periodontitis - A Clinical Trial & An Immunological Analysis |
| Date of disclosure of the study information | 2018/04/30 |
| Last modified on | 2023/06/04 01:00:26 |
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Basic information
Public title
Effect Of 1% Alendronate Gel as a Local Host Modulating Agent on IL-6 Levels in GCF in Non-Surgical Management of Chronic Periodontitis - A Clinical Trial & An Immunological Analysis
Acronym
1% Alendronate Gel in Chronic Periodontitis
Scientific Title
Effect Of 1% Alendronate Gel as a Local Host Modulating Agent on IL-6 Levels in GCF in Non-Surgical Management of Chronic Periodontitis - A Clinical Trial & An Immunological 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
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
sinhashraddha30@gmail.com
Sponsor or person
Institute
ITS Dental College, Hospital and Research Centre, 47, Knowledge Park III, I.T.S. Dental College, Hospital and research Centre
Institute
Department
Personal name
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
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
| 2023 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036980
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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