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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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