| CTRI Number |
CTRI/2018/06/014668 [Registered on: 29/06/2018] Trial Registered Prospectively |
| Last Modified On: |
25/06/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Herbal mouthwash for 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 |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr AmbiliR |
| Designation |
Professor |
| Affiliation |
PMS College of dental science and research |
| Address |
Department of periodontics,
PMS College of dental science and research, Trivandrum,kerala
Thiruvananthapuram
KERALA
695028
India |
| Phone |
9447463676 |
| Fax |
914722587874 |
| Email |
ambiliranjith@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr AmbiliR |
| Designation |
Professor |
| Affiliation |
PMS College of dental science and research |
| Address |
Department of periodontics,
PMS College of dental science and research, Trivandrum,kerala
Thiruvananthapuram
KERALA
695028
India |
| Phone |
9447463676 |
| Fax |
914722587874 |
| Email |
ambiliranjith@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr AmbiliR |
| Designation |
Professor |
| Affiliation |
PMS College of dental science and research |
| Address |
Department of periodontics,
PMS College of dental science and research, Trivandrum,kerala
Thiruvananthapuram
KERALA
695028
India |
| Phone |
9447463676 |
| Fax |
914722587874 |
| Email |
ambiliranjith@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Dr.Ambili.R,Devikripa,KRA A143/A,Thumbikkonam lane,Kudappanakunnu.P.O,Trivandrum-43,Kerala |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
NA |
| Type of Sponsor |
Other [] |
|
|
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 |
| DrAmbiliR |
PMS College of dental science and research,Department of periodontics,Room no: 8 |
Departmet of periodontics,Room no:8, PMS College of dental science and research, Vattappara,Trivandrum, Kerala
Thiruvananthapuram
KERALA |
9447463676
914722587874
ambiliranjith@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee-PMS College of dental science and research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
periodontal disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cholorhexidine mouthwash
|
dose 30ml,
frequency- twice daily
route of administration-topical as a mouthwash
TOTAL duration of therapy- 2 weeks |
| Intervention |
Herbal Mouthwash
|
dose-30ml
frequency-twice daily
route of administration-topical as a mouthwash
TOTAL duration-2 weeks of therapy |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Systemically healthy patients diagnosed with chronic generalized periodontitis.
2.Presence of gingival inflammation, GI≥ 2
3.≥ 20naturalteeth
4.Probing depth (PD) ≥ 5mm in> 30 % of sites
5.CAL ≥ 3mm in> 30% of sites
• Radiographic evidence of generalized alveolar bone loss>50%
• Those willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
 Patients with systemic diseases or other conditions that could influence the periodontal status;
 Patients who are currently under any medication and who have taken antibiotics or anti-inflammatory drugs for the past 3 months
 orthodontic devices, extended prosthetic ï¬xed devices, removable partial dentures, or overhanging restorations
 regular use of chemotherapeutic antiplaque/anti gingivitis products
 periodontal treatment performed within 6 months before study initiation
 Pregnant and lactating females
 Aggressive periodontitis
 Current smokers
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Differences in mean gingival bleeding |
Baseline to 14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in plaque,pocket depth |
Baseline to 14 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2 |
|
Date of First Enrollment (India)
|
01/07/2018 |
| 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="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. 60 patients with
chronic periodontitis will be selected and they will be randomly divided into 2
groups. Detailed periodontal examination will be done in all the patients followed
by scaling and rootplaning. Group I will be instructed to use herbal mouthwash
prepared by Kottaykkal aryavaidya shala
according to the composition described in patent (United States patent application US 13/883,551. 2013 Sep
19) twice daily for 2 weeks. Group II will be instructed to use chlorhexidine
mouthwash, which is considered as the gold standard mouthwash. Reevaluation will
be done after 2 weeks to evaluate the efficacy of the mouthwash in reducing
gingival inflammation and plaque accumulation.
|