Unique ID issued by UMIN | UMIN000036356 |
---|---|
Receipt number | R000041105 |
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 | 2019/03/31 |
Last modified on | 2019/03/31 08:08:14 |
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.
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.
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.
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.
Asia(except Japan) |
chronic periodontitis
Dental medicine |
Others
NO
1. To evaluate the effects of scaling and rootplaning on the periodontal parameters suchas 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.
Efficacy
Exploratory
Pragmatic
Phase III
Relative Attachment level (RAL) at baseline, 1 month and 3 months
Plaque Index (PI), Modified Sulcus Bleeding Index (mSBI), Probing Pocket Depth (PPD) at baseline, 1 month and 3 months.
Visual Analogue Scale (VAS) recorded at 3rd day
Interventional
Factorial
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
NO
2
Treatment
Medicine |
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.
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.
30 | years-old | <= |
60 | years-old | >= |
Male and Female
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 equalto 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.
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.
24
1st name | Dr. Nitanshi |
Middle name | |
Last name | khare |
School Of Dental Sciences, Sharda University,Greater Noida
Department of Periodontology
201306
Solace girls hostel Gautam buddha nagar knowledge park 2 201306
+918010641510
nitanshi.khare@gmail.com
1st name | Dr. Nitanshi |
Middle name | |
Last name | khare |
School of Dental Sciences, Sharda University
Department of Periodontology
201306
Solace girls hostel Gautam buddha nagar knowledge park 2 201306
+918010641510
http://www.umin.ac.jp/ctr/index.htm
nitanshi.khare@gmail.com
School of Dental Sciences, Sharda University,Greater Noida
Dr. Nitanshi Khare
Post Graduate student of MDS IIIrd year
Department of Periodontology
School of Dental Sciences, Sharda University,Greater Noida.
Self funding
School of Dental Sciences, Sharda University
Plot No. 32-34, Knowledge Park III, Greater Noida, Uttar Pradesh 201310
+918010641510
nitanshi.khare@gmail.com
NO
2016000410
School of Dental Sciences Sharda University
School of Dental sciences, sharda University
2019 | Year | 03 | Month | 31 | Day |
Unpublished
24
-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.
2019 | Year | 03 | Month | 31 | Day |
Completed
2016 | Year | 12 | Month | 19 | Day |
2016 | Year | 12 | Month | 19 | Day |
2017 | Year | 05 | Month | 09 | Day |
2018 | Year | 09 | Month | 06 | Day |
2018 | Year | 10 | Month | 05 | Day |
2018 | Year | 11 | Month | 24 | Day |
2019 | Year | 03 | Month | 31 | Day |
2019 | Year | 03 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041105
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |