| CTRI Number |
CTRI/2019/04/018697 [Registered on: 23/04/2019] Trial Registered Prospectively |
| Last Modified On: |
01/02/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Local Drug Delivery for the treatment of Periodontal Diseases |
|
Scientific Title of Study
|
Comparison of Effectiveness of Subgingivally Delivered Boric acid gel and Curcumin gel as an adjunct to Mechanotherapy in Chronic Periodontitis: A clinical study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ruchika Lulla |
| Designation |
PG student |
| Affiliation |
Sharad Pawar Dental College |
| Address |
Nanak Nagar Near Nankani Mangal Karyalaya
Rampuri Camp
Amravati
Wardha
MAHARASHTRA
444603
India |
| Phone |
7588752199 |
| Fax |
|
| Email |
ruchika.lulla@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyanka Jaiswal |
| Designation |
Associate Professor |
| Affiliation |
Sharad Pawar Dental College |
| Address |
Department of Periodontics
Sharad Pawar Dental College
Sawangi (M), wardha.
Department of Periodontics
Sharad Pawar Dental College
Sawangi (M), wardha.
Wardha
MAHARASHTRA
442004
India |
| Phone |
9960713010 |
| Fax |
|
| Email |
priyanka.banode@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ruchika Lulla |
| Designation |
PG student |
| Affiliation |
Sharad Pawar Dental College |
| Address |
Nanak Nagar Near Nankani Mangal Karyalaya
Rampuri Camp
Amravati
Wardha
MAHARASHTRA
444603
India |
| Phone |
7588752199 |
| Fax |
|
| Email |
ruchika.lulla@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Ayurvedic College
Salod (H), Wardha
Maharashtra |
|
|
Primary Sponsor
|
| Name |
not applicable |
| Address |
not applicable |
| Type of Sponsor |
Other [not applicable] |
|
|
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 Ruchika Lulla |
Datta Meghe Institute of Medical sciences Sharad Pawar Dental College |
Dept. of Periodontics
Room no. 3
Wardha
MAHARASHTRA |
7588752199
ruchika.lulla@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE DATTA MEGHE INSTITUTE OF MEDICAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 3||Administration, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Boric acid gel |
Based on the results of in vitro experiments, we will be using a 0.75% concentration of boric acid (pH 4.9) in this clinical study, but in gel form, for subgingival delivery once after completion of scaling and root planing. |
| Comparator Agent |
Curcumin gel |
Curcumin solution will be prepared by mixing 250 gms of freshly prepared rhizome of curcuma longa in 5 ml of ethanol and kept in hot air oven at 540 degree Celsius for 24 h. A residue obtained will be mixed with 95 ml of glycerol, which will be used as a natural local drug delivery. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients motivated to have the therapy and willing to complete the follow-up.
2. Patients with a minimum of 20 teeth.
3. Subjects who readily give informed consent for the study.
4. Systemically healthy subjects, with deep pockets.
5. Patients with no history of periodontal therapy ij the preceding 6 months or under any antibiotic therapy. |
|
| ExclusionCriteria |
| Details |
1. Patients on systemic boron therapy, those with a known or suspected allergy to boron supplementation or curcumin.
2. Patients who have undergone periodontal therapy in the last 6 months.
3. Patients who were taking and had consumed vitamin supplements, anti-inflammatory agents, or statins in the previous 3 months.
4. Patients with any systemic disorder affecting periodontal health.
5. Patients with infectious conditions other than periodontitis.
6. Regular users of mouthwashes.
7. Chronic alcoholics
8. Those with aggressive periodontitis.
9. Patients consuming tobacco in any form, smokers, alcoholics
10. Immunocompromised and systemically unhealthy patients.
11. Pregnant or lactating females. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Probing pocket depth reduction |
baseline, post-operatively 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical attachment level gain |
baseline, post-operatively 3 months and 6 months |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
Final Enrollment numbers achieved (Total)= "26"
Final Enrollment numbers achieved (India)="26" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
23/04/2019 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Periodontitis,
a chronic inflammatory disease, is induced by bacterial biofilms that initiate
host response in gingival connective tissue. It is considered an infection because there is a
bacterial etiology and an immune response. Sub gingival
environment is Ideal for pathogenic bacteria and
Sub gingival microorganisms are the principle
etiologic factor in the development of periodontitis. Conventional
therapy (e.g., scaling and root planing [SRP] and ultrasonic debridement)
without adjunctive chemotherapy is often sufficient to suppress bacterial
pathogens, thereby attaining periodontal health. Local delivery of antimicrobial agents in Periodontics
implies antimicrobial therapy placed directly in the sub gingival region. Borinic acid are quinoline esters, a
recently-identified class of new antibacterial compounds that contains boron. It
plays a role in inflammatory and immune response regulation. It
also plays a vital role in osteogenesis and the maintenance of bones. Curcumin, the primary active constituent of turmeric exhibits anti-inflammatory, anti-oxidant, anticarcinogenic, antiviral, and antimicrobial activities. Therefore, the present study will be undertaken to evaluate and compare the effectiveness of boric acid gel and curcumin gel as an adjunct to scaling and root planing in patients with chronic periodontitis. |