| CTRI Number |
CTRI/2020/07/026770 [Registered on: 24/07/2020] Trial Registered Prospectively |
| Last Modified On: |
14/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of green coffee gel in treatment of periodontal pocket in chronic periodontitis patient |
|
Scientific Title of Study
|
“Comparative evaluation of efficacy of green coffee and chlorhexidine gel as a local
drug delivery in periodontal pocket in chronic periodontitis patientsâ€: A
randomized controlled clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrAnkita Ashok Katkurwar |
| Designation |
Postgraduate student |
| Affiliation |
MGV KBH Dental collage nashik |
| Address |
MGVs KBH dental collage,mumbai agra road,panchavati nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
8975916733 |
| Fax |
|
| Email |
katkurwarankita@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swapna Mahale |
| Designation |
Professor and HOD |
| Affiliation |
MGV KBH Dental collage nashik |
| Address |
MGVs KBH dental collage,mumbai agra road,panchavati nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
9422764080 |
| Fax |
|
| Email |
drsamahale@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrAnkita Ashok Katkurwar |
| Designation |
Postgraduate student |
| Affiliation |
MGV KBH Dental collage nashik |
| Address |
MGVs KBH dental collage,mumbai agra road,panchavati nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
8975916733 |
| Fax |
|
| Email |
katkurwarankita@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGVs KBH dental collage, Nashik |
|
|
Primary Sponsor
|
| Name |
MGVs KBH dental collage |
| Address |
mumbai agra road,panchavati nashik |
| 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 Ankita Ashok Katkurwar |
MGVs KBH dental collage |
Room no 302,department of periodontics and oral implantology,postgraduate section
Nashik
MAHARASHTRA |
8975916733
katkurwarankita@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KBH dental college institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Chlorhexidine gel |
The chlorhexidine gel will be delivered subgingivally in
the periodontal pocket. The pocket opening will be covered with Coe-pak to retain
the material in the pocket, as well as to prevent the ingress of oral fluid. Subjects
will be recalled after 7 days for removal of the periodontal dressing |
| Intervention |
Green coffee gel |
The green coffee will be delivered subgingivally in
the periodontal pocket. The pocket opening will be covered with Coe-pak to retain
the material in the pocket, as well as to prevent the ingress of oral fluid. Subjects
will be recalled after 7 days for removal of the periodontal dressing |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient diagnosed with mild and moderate chronic periodontitis
2. Patients with persistent pocket depth of minimum 4 -6 mm having minimum of 2-3 sites.
3. Systemically healthy subjectS. |
|
| ExclusionCriteria |
| Details |
1.History of any previous periodontal therapy in the last 6 months.
2.Use of drugs such as antibiotics, anti-inflammatory, corticosteroids,chemotherapeutics or immunological modulators that might alter the expected response of the oral tissues.
3. Tobacco consumption in any form.
4. Systemic diseases influencing the periodontal disease.
5. Pregnant and lactating women.
6. Allergy to chlorhexidine and green coffee |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Plaque Index (PI) (Silness & Loe, 1964)
2.Gingival Index (GI) (Loe and Silness, 1963)
3. Sulcus Bleeding Index.(SBI)( Muhlemann H.R & Son,1971)
4.Probing Pocket Depth (PPD)
5.Relative Attachment Level (RAL) |
baseline, and after 1 as well as 3 month after placement of gel |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| colony forming unit |
At baseline and 3 month after placement of drug |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/08/2020 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study will be carried out in 45 patients with mild to moderate chronic periodontitis having minimum pocket depth of 5-7 mm in systemically healthy patients. Acrylic stent will be used to ensure reproducibility of measurements during the subsequent examinations of PPD, RAL.
All the patients will be screened for periodontal findings. Patients meeting the inclusion criteria will be considered for the present study. Scaling and root planing will be done. Patient will be recalled after 3-4 weeks for rechecking of periodontal findings. Persistent pockets of minimum 4-6 mm will be considered for the further study. Selected patients will be randomly divided into 3 groups:
Group A- subgingival application of green coffee gel (15 patients)
Group B- subgingival application of chlorhexidine gel (15 patients)
Group C- Scaling and root planing only (15 patients).
In selected sites, subgingival plaque sample will be collected by a sterile curette and colony forming unit will be assessed.
The experimental sites will be isolated with cotton rolls to prevent contamination from saliva. The green coffee or chlorhexidine gel will be delivered subgingivally in the periodontal pocket. The pocket opening will be covered with Coe-pak to retain the material in the pocket, as well as to prevent the ingress of oral fluid. Subjects will be recalled after 7 days for removal of the periodontal dressing. Reassessment of the clinical parameters will be done at 1 and 3 month and colony forming unit will be assessed after 3 months of placement of experimental drugs. In between these appointments the patients will ask to maintain the oral hygiene. No other chemical plaque control measures will be used during the trial period.
|