CTRI Number |
CTRI/2021/03/031768 [Registered on: 08/03/2021] Trial Registered Prospectively |
Last Modified On: |
06/03/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Other |
Public Title of Study
|
A clinical trial to study the efficacy of Licorice root extract in patients with severe gum diseases. |
Scientific Title of Study
|
Assessment of Licorice extract as local drug delivery in treatment of chronic periodontitis: A randomized 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 Anju Jayaram |
Designation |
Post Graduate Student Department Of Periodontics |
Affiliation |
Sri Hasanamba Dental College And Hospital. |
Address |
Department of periodontics
Sri Hasanamba Dental College and Hospital,
Vidyanagar, Hassan, Karnataka.
Hassan KARNATAKA 573201 India |
Phone |
9400990436 |
Fax |
|
Email |
dranjujayaram@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
VIVEKANANDA M R |
Designation |
Associate Professor |
Affiliation |
sri hasanamba dental college and Hospital |
Address |
Department Of Periodontics,
Sri Hasanamba Dental College and Hospital,
Vidyanagar, Hassan, Karnataka.India
Hassan KARNATAKA 573201 India |
Phone |
09980843531 |
Fax |
|
Email |
vivekcodsperio@ymail.com |
|
Details of Contact Person Public Query
|
Name |
VIVEKANANDA M R |
Designation |
Associate Professor |
Affiliation |
sri hasanamba dental college and Hospital |
Address |
Department Of Periodontics,
Sri Hasanamba Dental College and Hospital,
Vidyanagar, Hassan, Karnataka.India
Hassan KARNATAKA 573201 India |
Phone |
09980843531 |
Fax |
|
Email |
vivekcodsperio@ymail.com |
|
Source of Monetary or Material Support
|
Sri Hasanamba Dental College and Hospital |
|
Primary Sponsor
|
Name |
Sri Hasanamba Dental college |
Address |
Vidyanagar, Hassan,
Karnataka 573201 Ph No. 08172267843 |
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 |
Vivekananda M R |
Sri Hasanamba Dental College and Hospital |
Dr Vivekananda MR BDS MDS Associate Professor Sri Hasanamba Dental College and Hospital VidyanagarHassan 573202 KarnatakaEmail id vivekcodsperioymailcom Contact No 9980843431 Hassan KARNATAKA |
09980843531
vivekcodsperio@ymail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
institutional ethical comitee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
periodontitis |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
local drug delivery |
All the participants will be given a brief about the purpose of the study and informed consent will be taken from the subjects before undertaking the study. Subjects will be randomly assigned. |
Intervention |
local drug delivery |
All the participants will be given a brief about the purpose of the study and informed consent will be taken from the subjects before undertaking the study. Subjects will be randomly assigned. |
|
Inclusion Criteria
|
Age From |
25.00 Year(s) |
Age To |
50.00 Year(s) |
Gender |
Both |
Details |
1. Systemically healthy individual between the age group of 25-50.
2. Willingness to comply with the study protocol.
3. Subjects who were diagnosed with generalized chronic periodontitis with a pocket depth of ≥ 5mm
|
|
ExclusionCriteria |
Details |
1. Subjects suffering from any known systemic diseases.
2. Subjects who had received any antibiotic therapy in the last 6 months.
3. Subjects who are smokers.
4. Pregnancy and lactation.
5. Unable or not willing to comply with the study protocol.
6. Any periodontal treatment within six months.
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
reduction of clinical signs |
reduction of clinical signs |
|
Secondary Outcome
|
Outcome |
TimePoints |
comparing the scaling and root palning as adjuct therapy |
6 months |
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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 1/ Phase 2 |
Date of First Enrollment (India)
|
09/03/2021 |
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 yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Periodontal diseases are among the most common infections
disturbing human kind and can lead to the demolition of the periodontal
ligament, cementum, gingiva, and alveolar bone. Plaque is the primary
etiological factor in gingival inflammation. The progression of the disease is
by microbial biofilm formation(dental plaque) which leads to periodontal
inflammation and then attachment loss as well as alveolar bone loss.1
Despite
the advances in various field of medicine, oral infections and dental caries
are still considered as serious public health problems and inflict a major
burden to health care services around the world and especially in developing countries.
Development of resistance against antibiotics and antiseptics is a growing
cause of concern which has limited the preventive measures. Therefore, there is
a continuing need to search for new antimicrobial agents. Over the last decade,
plant antimicrobial activity has been studied in different region of the world.2
Licorice root [Glycyrrhiza glabra
Linn] is an ancient herb that had been used as a traditional medicine and sweetener
in various parts of the world for over 4,000 years. It belongs to the pea
family (Leguminosae) which includes 30 species, along which G. glabra & G.
uralensis is widely used as antibacterial and anti-inflammatory agents. The
roots and rhizomes of the licorice are used. Licorice has anti-inflammatory,
antiviral, antibacterial, antispasmodic, antioxidative, antiallergic, hepatoprotective, expectorant activities.3
As
there are no studies regarding Licorice extract as a local drug delivery, thus
this study aim to assess the efficacy of Licorice root extract as local drug delivery
as an adjunct to scaling and root planing in treatment of chronic periodontitis. |