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CTRI Number  CTRI/2024/07/071649 [Registered on: 31/07/2024] Trial Registered Prospectively
Last Modified On: 10/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of Guava extracts and Chlorhexidine in Chronic Periodontitis 
Scientific Title of Study   Comparison of Guava leaf extract gel versus Chlorhexidine gel in the treatment of Chronic Periodontitis. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Siddhant Bandopant Bhuyar 
Designation  Post Graduate Student 
Affiliation  Vidarbha Youth Welfare Society Dental College and Hospital 
Address  Vidarbha Youth Welfare Society Dental College and Hospital, Wadali - Tapowan Road, Amravati Amravati MAHARASHTRA 444602 India

Amravati
MAHARASHTRA
444602
India 
Phone  7972618120  
Fax    
Email  sidbhuyar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sameer Gajendra Kedia 
Designation  Professor and PG Guide 
Affiliation  Vidarbha Youth Welfare Society Dental College and Hospital 
Address  Department of Periodontology, Vidarbha Youth Welfare Society Dental College and Hospital, Wadali - Tapowan Road, Amravati Amravati MAHARASHTRA 444602 India

Amravati
MAHARASHTRA
444602
India 
Phone  9370152435  
Fax    
Email  drsameerkedia@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Siddhant Bandopant Bhuyar 
Designation  Post Graduate Student 
Affiliation  Vidarbha Youth Welfare Society Dental College and Hospital 
Address  Department of Periodontology, Vidarbha Youth Welfare Society Dental College and Hospital, Wadali - Tapowan Road, Amravati Amravati MAHARASHTRA 444602 India

Amravati
MAHARASHTRA
444602
India 
Phone  7972618120  
Fax    
Email  sidbhuyar@gmail.com  
 
Source of Monetary or Material Support  
Vidarbha Youth Welfare Societys Institute of Pharmacy and Research, Anjangao Bari Road, Badnera - 444701 
 
Primary Sponsor  
Name  Dr Siddhant Bhuyar 
Address  Department of Periodontology, Vidarbha Youth Welfare Society Dental College and Hospital, Wadali - Tapowan Road, Amravati Amravati MAHARASHTRA 444602 India 
Type of Sponsor  Other [self ] 
 
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 
Dr Siddhant Bhuyar  Vidarbha Youth Welfare Society Dental College and Hospital  Department of Periodontology, Room Number 16, First Floor. Amravati MAHARASHTRA
Amravati
MAHARASHTRA 
7972618120

sidbhuyar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee - Vidarbha Youth Welfare Societys Dental College & Hospital, Amravati  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K053||Chronic periodontitis. Ayurveda Condition: DANTAGATAROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Guava leaf extract gel, Reference: NA, Route: Topical, Dosage Form: Dantamanjan Churna/ Gum Paint, Dose: 1(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: -Preparation of Guava Extract: Young leaves of guava will be plucked from the plants from Amravati district, Maharashtra. Leaves samples will be washed with tap water, and treated with Tween 20 to remove surface debris, dried in a shade and will be grounded in an electric blender to obtain it as a coarse powder.One hundred grams of coarse powdered sample will be put into a large beaker and will be mixed with 1 L of
2Comparator Arm (Non Ayurveda)-ChlorhexidineCommercially available Chlorhexidine gel used as a Gum paint Dose=1mg of 1% concentration , Route= Topical , Dosage Form = Gumpaint , Frequency= bd , Duration= 3 months.
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients with mild and moderate Chronic periodontitis. 
 
ExclusionCriteria 
Details  1. Patients with systemic condition and/or have taken an antibiotic for more than 5 days during the last 3 weeks.
2. Patients with severe periodontitis.
3. Pregnant women and lactating mother.
4. Patient who have undergone flap surgery or major periodontal treatment in the past 6 months. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Plaque Index (PI), Gingival Index (GI), and
Papillary Bleeding Index (PBI) 
Baseline, One and Half Months and Three
Months 
 
Secondary Outcome  
Outcome  TimePoints 
Patients acceptability of the gels in terms of ease
of use, taste & flavor. 
Will be taken at the end of the study. 
 
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   N/A 
Date of First Enrollment (India)   18/08/2024 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  
Chronic Periodontitis is multifactorial infectious disease in which chronic inflammation of periodontal apparatus leads to the destruction of surrounding periodontal tissue of teeth, which in turn cause loosening of teeth in their socket and eventually loss of teeth. Mainly, inflammation of periodontal tissue is caused by the Gram negative anaerobic bacteria which are Actinobacillus actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia, and Tannerella forsythia. An immuno- pathological response is triggered inside the periodontal tissue by the entry of these bacteria and their toxins, which activates inflammatory cells such as lymphocytes and macrophages, which then release cytokines and other bioactive chemicals. According to a study done by the WHO in 2018, around 15%–35% of adults are suffering from periodontal disease. Classical signs and symptoms of periodontal diseases are halitosis, bleeding gums while brushing and chewing, swollen and tender gingiva, mobility of teeth in their socket and recession of gingiva. There is a pressing need for improved diagnostic methods and affordable treatment approaches for periodontal disease. The goal of periodontal treatment is to cure the inflamed tissues, reduce the number of periodontal pathogens through mechanical debridement (scaling and root planning) with or without various surgical modalities and alter the host tissue response. Along with debridement therapy, use of chemotherapeutic agents are some of the other clinical methods employed to treat periodontal disease.
Psidium guajava Linn, commonly known as guava, has been used in ayurvedic medicine as a therapeutic agent. Guava is proven for its antidiarrheal, antimicrobial, antiparasitic, antitussive, hepatoprotective, antioxidant, antigenotoxic, antimutagenic, antiallergic, anticancer, and anti-hyperglycemic effects and also a good source of vitamin C. The leaves of guava have been reported to be used for the maintenance of oral hygiene according to Sharma et al 2021. The flavonoid compounds and their derivatives can inhibit the growth of different bacteria by disruption of membrane and inactivation of extracellular proteins by forming irreversible complexes. The adhesion of early settlers of dental plaque to the tooth surface has a role in the initiation of the development of dental plaque. The anti-inflammatory action of guava is in its ability to inhibit prostaglandin, kinin, and histamine.
Despite the well-established antimicrobial properties of Guava gel, there is a lack of comprehensive research on their specific effects on periodontal pathogens, including their virulence factors and enzymes. Only a limited number of studies have investigated the efficacy of Guava leaf extract gel as phytomedicines against periodontal pathogens. Moreover, there is a notable absence of literature comparing the effects of Guava extract gel on oral Gram-negative microbes. This research holds significant novelty in its exploration of Guava extract gel for treating Chronic Periodontitis, presenting a pioneering approach in the realm of dental care. The distinctive aspect lies in the incorporation of herbal remedies, specifically Guava extracts, into periodontitis management— an innovative departure from conventional treatments like adjunctive to scaling and root planning in the form of Chlorhexidine which is considered gold standard. Therefore, the present study is planned to evaluate the efficacy of Guava on patients suffering from Chronic periodontitis.
Hence, the current research aims to assess and compare the effectiveness of a gel made from Guava leaf extract gel in treating Chronic Periodontitis with Chlorhexidine gluconate gel.
 
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