UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036164 |
|---|---|
| Receipt number | R000041075 |
| Scientific Title | EFFICACY OF 1% SODIUM CROMOGLYCATE GEL LOCAL DRUG DELIVERY AS AN ADJUNCT TO SCALING AND ROOT PLANING IN THE TREATMENT OF CHRONIC PERIODONTITIS: A CLINICAL STUDY |
| Date of disclosure of the study information | 2019/03/12 |
| Last modified on | 2019/03/12 03:46:42 |
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Basic information
Public title
EFFICACY OF 1% SODIUM CROMOGLYCATE GEL LOCAL DRUG DELIVERY AS AN ADJUNCT TO SCALING AND ROOT PLANING IN THE TREATMENT OF CHRONIC PERIODONTITIS: A CLINICAL STUDY
Acronym
EFFICACY OF 1% SODIUM CROMOGLYCATE GEL LOCAL DRUG DELIVERY AS AN ADJUNCT TO SCALING AND ROOT PLANING IN THE TREATMENT OF CHRONIC PERIODONTITIS: A CLINICAL STUDY
Scientific Title
EFFICACY OF 1% SODIUM CROMOGLYCATE GEL LOCAL DRUG DELIVERY AS AN ADJUNCT TO SCALING AND ROOT PLANING IN THE TREATMENT OF CHRONIC PERIODONTITIS: A CLINICAL STUDY
Scientific Title:Acronym
EFFICACY OF 1% SODIUM CROMOGLYCATE GEL LOCAL DRUG DELIVERY AS AN ADJUNCT TO SCALING AND ROOT PLANING IN THE TREATMENT OF CHRONIC PERIODONTITIS: A CLINICAL STUDY
Region
| Asia(except Japan) |
Condition
Condition
Chronic periodontitis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. To evaluate the effects of scaling and root planing on the periodontal parameters such as Plaque Index (PI), Modified Sulcus Bleeding Index (mSBI), Probing Pocket Depth (PPD), Relative Attachment level (RAL) in patients with chronic periodontitis.
2. To evaluate the effects of 1% sodium cromoglycate gel as an adjunct to scaling and root planing on the periodontal parameters such as Plaque Index (PI), Modified Sulcus Bleeding Index (mSBI), Probing Pocket Depth (PPD), Relative Attachment Level (RAL) in patients with chronic periodontitis.
3.To compare the effects of 1% sodium cromoglycate gel and placebo gel as an adjunct to scaling and root planing on the periodontal parameters such as Plaque Index (PI), Modified Sulcus Bleeding Index (mSBI), Probing Pocket Depth (PPD), Relative Attachment Level (RAL)in patients with chronic periodontitis.
4.To assess the patient pain related outcome using Numeric Pain Rating Visual Analogue Scale (VAS).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Relative Attachment Level (RAL) recorded at
baseline, 1 month and 3 months.
Key secondary outcomes
Plaque Index (PI), Modified Sulcus Bleeding Index (mSBI), Probing Pocket Depth (PPD) at baseline, 1 month, 3 months. Visual Analogue Scale (VAS) at 3rd day
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients were randomly allocated in test and control sites. In the Test sites 1% sodium cromoglycate gel was delivered after scaling and root planing. Plaque index (PI),Relative Attachment Level (RAL), Modified Sulcus Bleeding index (mSBI), and Probing Pocket Depth (PPD) were recorded at Baseline, 1 month and 3months.
Interventions/Control_2
In control sites after scaling and root planing local drug delivery of placebo gel was done.
Plaque index (PI), Relative Attachment Level(RAL), Modified Sulcus Bleeding index (mSBI),and Probing Pocket Depth (PPD) were recorded at Baseline, 1 month and 3 months.
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
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Willingness to comply with the study protocol.
Subjects in the age group more than or equal to 30 years without any systemic disease.
More than or equal to 20 teeth present in the oral cavity.
Patients with moderate chronic periodontitis having more than or equal to 2 interproximal sites with Clinical Attachment Loss more than or equal to 4 mm not on the same tooth and interproximal sites with Probing Pocket Depth more than or equal to five mm also not onthe same tooth each tooth site in two different quadrants.
Key exclusion criteria
Patient with any systemic disease.
Patient with aggressive periodontitis.
Users of tobacco in any form.
Patient on systemic mast cell stabilizer therapy.
Patient who had undergone periodontal therapy in previous 6 months.
Individual with known or suspected allergy to mast cell stabilizer group.
Pregnant or lactating women.
Patient with history of Antibiotic therapy for any chronic inflammatory condition with in six months prior to study.
Patient not willing to give written consent.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Dr. Nitanshi |
| Middle name | |
| Last name | khare |
Organization
School Of Dental Sciences, Sharda University,Greater Noida
Division name
Department of Periodontology
Zip code
201306
Address
Greater noida
TEL
+918010641510
nitanshi.khare@gmail.com
Public contact
Name of contact person
| 1st name | Dr. Nitanshi |
| Middle name | |
| Last name | Khare |
Organization
School of Dental Sciences, Sharda University
Division name
Department of Periodontology
Zip code
201306
Address
Plot No. 32-34, Knowledge Park III, Greater Noida, Uttar Pradesh 201306
TEL
+918010641510
Homepage URL
http://www.umin.ac.jp/ctr/index.htm
nitanshi.khare@gmail.com
Sponsor or person
Institute
Department of Periodontology, School of Dental Sciences, Sharda University
School of Pharmacy, Sharda University
Institute
Department
Personal name
Funding Source
Organization
Dr. Nitanshi Khare
Post Graduate student of MDS IIIrd year
Department of Periodontology
School of Dental Sciences, Sharda University,Greater Noida.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
School of Dental Sciences, Sharda University
Address
Plot No. 32-34, Knowledge Park III, Greater Noida, Uttar Pradesh 201310
Tel
+0918010641510
nitanshi.khare@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
2016000410
Org. issuing International ID_1
School of Dental Sciences Sharda University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
School of Dental Sciences, Sharda University, Greater Noida
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 03 | Month | 12 | 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
24
Results
-At 3 months follow up, the local drug delivery of 1% sodium cromoglycate gel and placebo gel showed significantly more improvement in Plaque index and Relative Attachment Level in test sites as compared to the control sites (p<0.001).
-For Modified sulcus bleeding index and probing pocket depth the statistically significant reduction was seen at 1 month and 3 months in test sites (p<0.001).
-No pain related to the 1% sodium cromoglycate and placebo gel observed using VAS Scale.
Results date posted
| 2019 | Year | 03 | Month | 12 | Day |
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 | 12 | Month | 29 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 29 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 09 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 26 | Day |
Date of closure to data entry
| 2018 | Year | 10 | Month | 05 | Day |
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 11 | Month | 24 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 03 | Month | 12 | Day |
Last modified on
| 2019 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041075
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