| CTRI Number |
CTRI/2019/10/021574 [Registered on: 09/10/2019] Trial Registered Prospectively |
| Last Modified On: |
08/10/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Dentistry
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
ayurvedic mouthwash to manage gum disease |
|
Scientific Title of Study
|
Evaluation of the Efficacy of an herbal mouthwash in the Management
of Chronic Periodontitis – a Randomized controlled clinical trial
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NA |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr AmbiliR |
| Designation |
Professor |
| Affiliation |
Departmnet of periodontics,PMS College of dental science and resarch |
| Address |
Departmnet of periodontics,PMS College of dental science and resarch
Thiruvananthapuram
KERALA
695028
India |
| Phone |
|
| Fax |
|
| Email |
ambiliranjith@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr AmbiliR |
| Designation |
Professor |
| Affiliation |
Departmnet of periodontics,PMS College of dental science and resarch |
| Address |
Departmnet of periodontics,PMS College of dental science and resarch
Thiruvananthapuram
KERALA
695028
India |
| Phone |
|
| Fax |
|
| Email |
ambiliranjith@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr AmbiliR |
| Designation |
Professor |
| Affiliation |
Departmnet of periodontics,PMS College of dental science and resarch |
| Address |
Departmnet of periodontics,PMS College of dental science and resarch
Thiruvananthapuram
KERALA
695028
India |
| Phone |
|
| Fax |
|
| Email |
ambiliranjith@yahoo.com |
|
|
Source of Monetary or Material Support
|
| herbal drugs will be provided by Ceego Lab Pvt Ltd, Chennai |
|
|
Primary Sponsor
|
| Name |
Ceego Lab Pvt Ltd Chennai |
| Address |
Wangs Kitchen, Old 96 / 6 , New 23 / 6 , Dr.Ambethkar Road ,1st Floor, Kodambakkam, Chennai, Tamil Nadu 600024 Opp To, 23, Dr Ambedkar Rd, Dr.Subbaraya Nagar, Kodambakkam, Chennai, Tamil Nadu 600024 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 AmbiliR |
PMS College of Dental Science and Research |
room no 8, department of periodontics,Golden Hills, Vattapara, Venkode, Thiruvananthapuram, Kerala 695028
Thiruvananthapuram
KERALA |
9447463676
ambiliranjith@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PMS dental college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A498||Other bacterial infections of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
chlorhexidine mouthwash |
10ml of commercially available 0.12% chlorhexidine will be diluted with equal quantity of water and patient will be instructed to use it twice daily for 2 weeks |
| Intervention |
herbal mouthwash |
patients will be instructed to rinse herbal mouthwash in whole extract liquid form as well as 2 powder forms (active ingredient powder and whole extract powder) 2 times daily for 2 weeks |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
• Systemically healthy patients diagnosed with chronic generalized periodontitis.
• Presence of gingival inflammation, GI≥ 2
• ≥ 20naturalteeth
• Probing depth (PD) ≥ 5mm in> 30 % of sites
• CAL ≥ 3mm in> 30% of sites
• Radiographic evidence of generalized alveolar bone loss>50%
• Those willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1. Patients with systemic diseases or other conditions that could influence the periodontal status
2.Patients who are currently under any medication and who have taken antibiotics or anti-inflammatory drugs for the past 3 months
3.orthodontic devices, extended prosthetic ï¬xed devices, removable partial dentures, or overhanging restorations
4.regular use of chemotherapeutic antiplaque/anti gingivitis products
5.periodontal treatment performed within 6 months before study initiation
6.Pregnant and lactating females
7.Aggressive periodontitis
8.Current smokers
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| change in bleeding on probing |
baseline and 2 weeks after scaling and root debridement |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| plaque accumulation |
baseline and 2 weeks after scaling and root debridement |
| pocket depth reduction |
baseline and 2 weeks after scaling and root debridement |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
15/10/2019 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The aim of the study is to evaluate the efficacy of an herbal mouthwash in the Management of Chronic Periodontitis in comparison with chlorhexidine mouthwash. 120 patients with chronic periodontitis will be selected and they will be randomly divided into 4 groups. Detailed periodontal examination will be done in all the patients followed by scaling and rootplaning. Group I will be instructed to use liquid form of herbal mouthwash, Group II will be instructed to use 30g active ingredient of drug in powder form diisolved in water , Group III will be instructed to use 50 g whole extract of herbal drug dissolved in water and Group IV will be instructed to use chlorhexidine mouthwash, which is considered as the gold standard mouthwash. Herbal drug in liquid and powder form will be prepared by Ceego Labs Pvt. Ltd, Chennai according to the composition described in patent (United States patent application US 13/883,551. 2013 Sep 19). the application of mouthwash is recommended twice daily for 2 weeks. Reevaluation will be done after 2 weeks to evaluate the efficacy of the mouthwash in reducing gingival inflammation and plaque accumulation. |