| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K053||Chronic periodontitis. Ayurveda Condition: DANTAGATAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other 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 | | 2 | Comparator Arm (Non Ayurveda) | | - | Chlorhexidine | Commercially 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. |