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CTRI Number  CTRI/2024/03/064158 [Registered on: 14/03/2024] Trial Registered Prospectively
Last Modified On: 14/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   In addition to clenaing the teeth use of nano-biofusion gel as an additional aid in periodontitis patients 
Scientific Title of Study   Clinical efficacy of nano-bio-fusion gel as an adjunct to non-surgical periodontal therapy in chronic periodontitis 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shahanaz Shaik 
Designation  3rd year Postgraduate 
Affiliation  KLE VK Institute of Dental Sciences 
Address  Department of Periodontics, KLE VK Institue Of Dental Sciences, Belagavi
Department of Periodontics, KLE VK Institue Of Dental Sciences, Belagavi
Belgaum
KARNATAKA
590010
India 
Phone  8074821125  
Fax    
Email  sk.shahanaz21@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Neelamma Shetti 
Designation  Reader 
Affiliation  KLE VK Institute of Dental Sciences 
Address  Department of Periodontics, KLE VK Institute of Dental Sciences, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  7795447015  
Fax    
Email  neelushetti1@gmail.com  
 
Details of Contact Person
Public Query
 
Name  shahanaz shaik 
Designation  3rd year Postgraduate 
Affiliation  KLE VK Institute of Dental Sciences 
Address  KLE VK Institute Of Dental Sciences, Nehru nagar Belagavi
KLE VK Institute Of Dental Sciences, Nehru nagar Belagavi
Belgaum
KARNATAKA
590010
India 
Phone  8074821125  
Fax    
Email  sk.shahanaz21@gmail.com  
 
Source of Monetary or Material Support  
KLE VK Institute Of Dental Sciences Nehru nagar, Belagavi, 590010 Karnataka. 
 
Primary Sponsor  
Name  Dr Shahanaz Shaik 
Address  Department Of Periodontics, KLE VK Institution Of Dental Sciences, BELAGAVI- 590010  
Type of Sponsor  Other [Self funded] 
 
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 Shahanaz Shaik  KLE VK Institute Of Dental Sciences  Department Of Periodontics, Belagavi- 590010
Belgaum
KARNATAKA 
8074821125

sk.shahanaz21@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional reaserch and ethics comittee KLE VKIDS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  k 53 - chronic periodontitis patients 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nono- biofusion gel   Clinical efficacy of nano-bio-fusion gel as an adjunct to non-surgical periodontal therapy in chronic periodontitis 
Comparator Agent  Ultrasonic scaling  Compare with non surgical periodontal therapy 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1.Age group of 25-55 years
2.Apparently Healthy individual
3.Patient with chronic periodontitis
4.Pocket depth of 4mm to 6mm
5.patient who are willing to given informed consent
 
 
ExclusionCriteria 
Details  1.Histroy of systemic diseases.
2.Smoking
3.Previous history of any periodontal treatment before 6 months.
4.Pregnancy and lactating woman
5.Under medication of any antibiotic/drugs that after the periodontal status.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Probing depth (PD)
Clinical attachment level (CAL)
 
baseline and 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Plaque index(PI)
Gingival index(GI) 
baseline & 3 months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   23/03/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Periodontal disease [PD] is an immuno-inflammatory destructive disease of periodontal tissues characterised by loss of soft tissue attachment and alveolar bone resorption caused by pathogenic microorganisms resulting in pocket formation and or gingival recession.             

Owing to the chronic nature of the disease, most of the patients report to the dentist only when the disease has reached the established destructive stage, thus requiring a comprehensive treatment procedure which is time consuming and the outcome may not be promising in most of the cases. It is worth mentioning that the deleterious effects of PD are not limited to the oral cavity, but extends its clutches to gain ready access to the systemic circulation through the pocket epithelium, eliciting host immuno-inflammatory response, eventually resulting in systemic complications. PD starts as an inflammatory reaction confined to the gingival tissue (gingivitis), but when left untreated it progresses to involve the periodontal ligament, cementum and supporting alveolar bone, resulting in pocket formation which provides a favourable environment for the growth of pathogenic anaerobic microorganisms.

The treatment of periodontal pocket by mechanical removal of local factors and disruption of subgingival plaque biofilm is mandatory. Therefore, scaling and root planning treatment of choice of these conditions.

With the growing understanding about microbial etiopathogenesis of PD, the need for development of novel technologies has resulted in the evolution of multiple advanced systemic or local/intra pocket antimicrobial delivery systems. Nevertheless, most of the systemic antimicrobials are associated microbial resistance with its inadvertent use, failure to reach the site of infection and attain adequate concentration and poor tissue penetration. Owing with these disadvantages with systemic antimicrobials local Drug Delivery agents have been introduced. LDDS, the therapeutic goal is achieved by placing the antimicrobial agents directly in the sub gingival sites/periodontal pocket, which releases the active drug in an immediate or controlled/sustained fashion to combat the microbial attack, simultaneously minimizing its undesirable effects on non-oral systemic/body sites. LDDS have several advantages over systemic antimicrobial agents, which include minimally invasive and direct application at the site of infection, avoidance of gastro-intestinal issues and first pass metabolism, reduction in the dose and frequency of drug administration. Placement of LDDS is aided by the presence of periodontal pocket, which acts as natural reservoir in which gingival crevicular fluid (GCF) provides hydrated environment that boosts distribution of the drug throughout the pocket. As an adjacent scaling, many chemical agents such as chlorohexidine, herbal agents such as propolis, aloe vera green tea extracts, neem, curcumin have gained popularity for local drug delivery.Propolis produced by honeybees is a resinous mixture collected from parts of plants, buds, and exudates. In 1908, the first scientific work with propolis, illustrating its composition and pleiotropic property, was published and was first patented in 1968. Nowadays, propolis is a natural remedy in the different formulation in the field of medicine and dentistry. Vitamin C, a key processor of cell growth, healing, and repair of tissue, influences the metabolism of collagen within the periodontium. It also maintains the epithelial barrier function to bacterial products and integrity of periodontal microvasculature. Vitamin E serves as an antioxidant to limit free radical and to protect cells from lipid peroxidation. Vitamin E works in synergistic with Vitamin C and maintains the integrity of the cell membranes.

The oral cavity being a natural moist environment, the potency and effectiveness of the topical application of various agents to prevent progression of disease are markedly reduced. Nano-Bio Fusion (NBF) gingival gel used in the study is a patented scientifically formulated, bio adhesive antioxidant gel harvesting naturally occurring antioxidants for targeted action. It mainly acts based on the NBF technology which allows the ultrafine antioxidants to surpass the moist intraoral environment, enter the cells and rejuvenate, revitalize, support, protect, and optimize gum and soft oral tissue. The natural antioxidant power of propolis, vitamin C, and vitamin E is amplified with Nano Bio-Fusion technology. For example, nano Vitamin C is ten times more potent in hundred times smaller quantities, than Vitamin C on its own. Once applied, NBF gel creates nano-bioactive protective film which results in increased absorption, resulting in improved clinical effectiveness and visible results after application.

 
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