| 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
|
|
|
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
|
|
|
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. |