| CTRI Number |
CTRI/2018/05/013652 [Registered on: 03/05/2018] Trial Registered Prospectively |
| Last Modified On: |
26/04/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
To Evaluate if usage of curcumin gel along with scaling and root planing can bring better results then using scaling and root planing alone |
|
Scientific Title of Study
|
Evaluation of efficacy of Curcumin gel as local drug delivery when used as an adjunct to scaling and root planing in chronic generalized periodontitis patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kalyani Prapurna Sistla |
| Designation |
post graduate student |
| Affiliation |
sri rajiv gandhi college of dental sciences |
| Address |
department of periodontology
sri rajiv gandhi college of dental sciences
chola nagar
RT nagar post
bengaluru
323 A SECTOR 8 UKKUNAGRAM VISHAKAPATNAM ANDHRA PRADESH
Bangalore
KARNATAKA
560032
India |
| Phone |
9902246366 |
| Fax |
|
| Email |
drkalyanisvr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kalyani Prapurna Sistla |
| Designation |
post graduate student |
| Affiliation |
sri rajiv gandhi college of dental sciences |
| Address |
department of periodontology
sri rajiv gandhi college of dental sciences
chola nagar
RT nagar post
bengaluru
323 A SECTOR 8 UKKUNAGRAM VISHAKAPATNAM ANDHRA PRADESH
Bangalore
KARNATAKA
560032
India |
| Phone |
9902246366 |
| Fax |
|
| Email |
drkalyanisvr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kalyani Prapurna Sistla |
| Designation |
post graduate student |
| Affiliation |
sri rajiv gandhi college of dental sciences |
| Address |
department of periodontology
sri rajiv gandhi college of dental sciences
chola nagar
RT nagar post
bengaluru
323 A SECTOR 8 UKKUNAGRAM VISHAKAPATNAM ANDHRA PRADESH
Bangalore
KARNATAKA
560032
India |
| Phone |
9902246366 |
| Fax |
|
| Email |
drkalyanisvr@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
kalyani prapurna sistla |
| Address |
sri rajiv gandhi college of dental sciences cholanagar RT nagar bangalore 32 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kalyani prapurna |
sri rajiv gandhi college of dental sciences |
room no 12 2nd floor department of periodontology and implantology sri rajiv gandhi college of dental sciences cholanagar RT nagar post bangalore 32
Bangalore
KARNATAKA |
9902246366
drkalyanisvr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| sri rajiv gandhi college of dental sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
scaling and root planing alone |
the site where only scaling and root planing will be performed |
| Intervention |
scaling and root planing and curcumin gel |
scaling and root planing followed by application of curcumin gel in the contralateral side of the same patient |
|
|
Inclusion Criteria
|
| Age From |
25.00 Day(s) |
| Age To |
40.00 Day(s) |
| Gender |
Both |
| Details |
1.Patients willing to take part in the study
2.Subjects of the age group between 25 to 40 years without any systemic disease
3.Patient with more than 20 natural teeth
4.Patient with chronic periodontitis having a PPD of ≥5 mm.
• Patients with no history of allergies.
|
|
| ExclusionCriteria |
| Details |
1.Pregnant woman and lactating mothers
2.Teeth with both endo‑perio lesions
3.Patient with use of tobacco or tobacco related products
4.Patient on antibiotics within 3 months prior to study
• Patients having systemic diseases like diabetes mellitus, hypertension, bleeding disorders, hyperparathyroidism, and compromised medical conditions
•Patients who have had periodontal treatment in last 6 months.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| clinical attachment loss and pocket depth |
base line and after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| plaque index and gingival index |
baseline and after 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/05/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Periodontitis and dental
caries are among the two most prevalent diseases of oral cavity. Dental plaque
and calculus are the pre requisite for any of periodontal diseases and complete
elimination of plaque and calculus is the basic goal of any periodontal treatment.
The present study is designed to evaluate the efficacy of local drug delivery
with curcumin, gel post scaling and root planing and its effect on clinical
parameters like plaque, gingival scores and pocket depth and CAL.
10 patients with two
sites in the contralateral quadrants having probing pocket depths (PPDs) of ≥5 mm will be selected. Full mouth scaling and root planing (SRP) will be performed which will be followed by
application of curcumin gel on a single side. Assessment of plaque index (PI),
gingival index (GI), PPD, and clinical attachment levels (CALs) will be done at
baseline and at 4th week. |