| CTRI Number |
CTRI/2018/05/013986 [Registered on: 21/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
10/11/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To clinically evaluate different types of mouthwashes in swollen gums |
|
Scientific Title of Study
|
Comparative evaluation of Triphala, Aloevera and Chlorhexidine mouthwash on Gingivitis: A randomized placebo-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 |
Vivek Bypalli |
| Designation |
Post graduate student |
| Affiliation |
Vishnu Dental College |
| Address |
Vishnu dental college,Vishnupur,
Bhimavaram,
West godavari district
West Godavari ANDHRA PRADESH 534202 India |
| Phone |
9640166656 |
| Fax |
|
| Email |
vivek.baipalli@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Gautami S Penmetsa |
| Designation |
Professor |
| Affiliation |
Vishnu Dental College |
| Address |
Vishnu dental college,Vishnupur,
Bhimavaram,
West godavari district
West Godavari ANDHRA PRADESH 534 202 India |
| Phone |
9951011618 |
| Fax |
|
| Email |
gautamipenmetsa@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Gautami S Penmetsa |
| Designation |
Professor |
| Affiliation |
Vishnu Dental College |
| Address |
Vishnu dental college,Vishnupur,
Bhimavaram,
West godavari district
West Godavari ANDHRA PRADESH 534 202 India |
| Phone |
9951011618 |
| Fax |
|
| Email |
gautamipenmetsa@gmail.com |
|
|
Source of Monetary or Material Support
|
| vishnu dental college, Bhimavaram |
|
|
Primary Sponsor
|
| Name |
PI |
| Address |
department of periodontics and implantology, block 2,
vishnu dentalcollege,bhimavaram. |
| Type of Sponsor |
Other [private dental 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 |
| vivekbypalli |
Vishnu Dental College |
department of periodonticsand implantology,
block 2,room number 7, bhimavaram.
West Godavari ANDHRA PRADESH |
9640166656
vivek.baipalli@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commite |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K051||Chronic gingivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Aloevera |
Aloe vera or Aloe barbadensis miller (family Liliaceae) is a tropical plant easily grown in hot and dry climates of Africa, Asia, America and Europe.
it is antiinflammatory, antibacterial, antifungal, antiviral, wound healing, pain relief. Advised 10ml twice daily for 30 days. |
| Intervention |
chlorhexidine |
chlorhexidine is an antimicrobial agent.it prevents plaque accumulation. Hence it is a antiplaque and antigingival agent. Advised 10ml twice daily for 30days. |
| Comparator Agent |
Triphala |
TRP is considered a traditional Ayurvedic medicine made from fruits of three medicinal trees:
Amalaki (Emblica officinalis)
Bibhitaki (Terminalia belerica)
Haritaki (T. chebula)
It has antibacterial and antiseptic properties, and anti-inflammatory action.
Advised 10ml of mouthwash twice daily for 30 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
age groups of 18-40 years with chronic generalized gingivitis.
Minimum of 20 teeth in the mouth.
No periodontal treatment was done in last 6 months.
|
|
| ExclusionCriteria |
| Details |
poor oral hygiene
Pregnancy and lactating women
Patients on antibiotic therapy for last 1 month.
Smokers
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| gingival index,bleeding index |
Baseline,15 days,30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Plaque index |
Baseline,15 days,30 days |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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 4 |
|
Date of First Enrollment (India)
|
02/01/2017 |
| 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="1" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Dental plaque is associated with the most prevalent oral diseases like dental caries and periodontal diseases. The removal of plaque is a determining component in the prevention of these diseases. The use of mechanical agents is a simple and cost effective method that has been demonstrated to be effective in control of gingivitis. Most of the individuals do not practice an acceptable standard of mechanical plaque removal due lack of dexterity in performing oral hygiene methods. Aloe barbadensis, also known as aloevera, has the greatest medicinal value. Aloevera was regarded as the most effective for general therapeutic and medicinal uses. The parenchymal tissue makes up the inner portion of Aloe leaves and produces a clear, thin, tasteless, jelly-like material called Aloevera gel. The gel contains approximately 98.5% water, with the remaining 0.5–1% solid material consisting of a wide range of compounds including vitamins A, C and E. Vitamin B1 (thiamine), niacin, vitamin B2 (riboflavin), choline, folic acid, traces of vitamin B12 and enzymes such as acid phosphatase, alkaline phosphatase, amylase, lactic dehydrogenase and lipase. The purpose of the study is to evaluate the efficacy of the aloevera in treatment of gingivitis. |