| CTRI Number |
CTRI/2024/01/061413 [Registered on: 12/01/2024] Trial Registered Prospectively |
| Last Modified On: |
10/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To know if the mouth wash prepared from certain herbal products is effective and safe to treat the gingivitis |
|
Scientific Title of Study
|
Evaluation of the safety and the efficacy of a novel polyherbal mouthwash containing Emblica officinalis,Cinnamomum cassia,Silicate of magnesia,Nigella sativa and Eucalyptus globulus oil in patients with gingivitis:A randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RASHMI AZIM |
| Designation |
MDS(Periodontics) |
| Affiliation |
DR. Z. A. DENTAL COLLEGE, A.M.U. ALIGARH |
| Address |
DEPARTMENT OF PERIODONTIA AND COMMUNITY DENTISTRY
DR Z. A. DENTAL COLLEGE,
ALIGARH MUSLIM UNIVERSITY,
ALIGARH
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9045618522 |
| Fax |
|
| Email |
rashmi.azim@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Vivek Kumar Sharma |
| Designation |
Professor |
| Affiliation |
DR Z. A. DENTAL COLLEGE, A.M.U. |
| Address |
DEPARTMENT OF PERIODONTIA AND COMMUNITY DENTISTRY
DR Z A DENTAL COLLEGE
ALIGARH MUSLIM UNIVERSITY
ALIGARH
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9557870057 |
| Fax |
|
| Email |
yeahlifehai@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Rashmi Azim |
| Designation |
Junior Resident |
| Affiliation |
DR Z. A. DENTAL COLLEGE A.M.U. |
| Address |
DEPARTMENT OF PERIODONTIA AND COMMUNITY DENTISTRY
DR Z A DENTAL COLLEGE
ALIGARH MUSLIM UNIVERSITY
ALIGARH
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9045618522 |
| Fax |
|
| Email |
rashmi.azim@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR Ziauddin Ahmad Dental College AMU ALIGARH |
|
|
Primary Sponsor
|
| Name |
DR ZADC AMU ALIGARH |
| Address |
DR. Z.A.D.C. A.M.U; ALIGARH |
| Type of Sponsor |
Government medical college |
|
|
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 |
| RASHMIAZIM |
DR. Ziauddin Ahmad Dental College |
DEPARTMENT OF PERIODONTIA AND COMMUNITY DENTISTRY
DR ZIAUDDIN AHMAD DENTAL COLLEGE
ALIGARH MUSLIM UNIVERSITY
Aligarh
UTTAR PRADESH |
9045618522
rashmi.azim@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONALETHICSCOMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A488||Other specified bacterial diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CHLORHEXIDINE MOUTHWASH |
10 ML ONCE A DAY ORALLY AFTER TOOTH BRUSHING for 14 days |
| Intervention |
POLYHERBAL MOUTHWASH |
EMBLICA OFFICINALIS,CINNAMOMUM CASSIA,SILICATE OF MAGNESIA,NIGELLA SATIVA AND EUCALYPTUS OIL
10 ML ONCE A DAY ORALLY AFTER TOOTH BRUSHING FOR 14 DAYS
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
APPARENTLY HEALTHY INDIVIDUALS WITH
PRESENCE OF ATLEAST 20 NATURAL TEETH
DIAGNOSIS OF GINGIVITIS-DENTAL BIOFILM INDUCED |
|
| ExclusionCriteria |
| Details |
1)PREGNANCY AND LACTATION
2)DECOMPENSATED SYSTEMIC DISEASE
3)DEGENERATIVE BONE DISEASE
4)SJOGREN SYNDROME
5)ADVANCED PERIODONTAL OR ORTHODONTIC DISEASE
6)HISTORY OF ORAL PROPHYLAXIS WITHIN 6 MONTHS
7)HISTORY OF TAKING ANTIBIOTICS,ANTICOAGULANT,IMMUNOSUPPRESSIVE,ANTI-INFLAMMATORY MEDICATION OR USING ANTI-BACTERIAL
MOUTH RINSES FOR PAST 6 MONTHS.
8)SMOKING,DRUG AND ALCOHOL ABUSE
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)DECREASE IN SALIVARY CRP LEVEL
2)DECREASE IN GINGIVAL INDEX,GINGIVAL BLEEDING INDEX,PLAQUE INDEX |
three months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| effectiveness of polyherbal mouth wash |
three months |
|
|
Target Sample Size
|
Total Sample Size="156"
Sample Size from India="156"
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)
|
20/01/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Periodontal diseases have a
destructive effect on the supporting tooth tissues. The mildest form of these
diseases is gingivitis which is characterized by bleeding, plaque formation and
gum inflammation .Several lines of evidence have
shown that elimination of microbial dental plaque biofilm prevents gingivitis. In addition to mechanical oral hygiene approaches, there is a need for additional measures to control
bacterial plaque formation by using antimicrobial dentifrices or anti-plaque mouthwashes. Chlorhexidine, a bisguanide
is considered benchmark of antimicrobial rinses due to its high substantivity
and wide range of activity. Chlorhexidine is not a ‘Miraculous solution’ as it has
definite after effects like taste alteration, mucosal irritation, dry mouth,
tooth discoloration, cytotoxic effect.
Based on the ill-effects of chlorhexidine, World Health Organization admonished
researchers to probe the potential of herbs and plant extracts. Hence, finding newer antiplaque
and antimicrobial agents with a natural origin is important to increase
treatment compliance and reduce adverse effects upon long-term application. In dentistry, Herbal concentrates
were used to lessen inflammation, prevent dental caries, to heal gingivitis
& periodontitis, and as antimicrobials & antioxidants. The natural products used in this
study were Indian gooseberry (Emblica Officinalis), cinnamon(Cinnamomum Cassia), Hydrated
Magnesium silicate(silicate of magnesia)
, Black seed(Nigella Sativa),Eucalyptus oil(Eucalyptus Globulus) .The
efficacy of all the substances were proven individually. The combined effect of the substances was not studied previously . Thus the aim of the study was to
evaluate the clinical safety and
efficacy of polyherbal mouthwash containing Indian gooseberry, Cinnamon, Hydrated magnesium silicate, black seed And Eucalyptus oil against commercially
available chlorhexidine mouthwash.
|