UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036164
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email nitanshi.khare@gmail.com

Sponsor
Institute Department of Periodontology, School of Dental Sciences, Sharda University

School of Pharmacy, Sharda University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041075

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.