| CTRI Number |
CTRI/2024/10/075032 [Registered on: 10/10/2024] Trial Registered Prospectively |
| Last Modified On: |
09/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Testing the Effectiveness of Zinc Oxide Nanoparticles in Light Therapy to Help Treat Gum and bone Disease Alongside Deep Cleaning Treatment. |
|
Scientific Title of Study
|
Clinical Evaluation of Effectiveness of Zinc Oxide Nanoparticles as Photocatalyst in Photodynamic Therapy as an Adjunct to SRP in the Management of Periodontitis – A Randomized Control Trial |
| 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 Srishty Sharma |
| Designation |
Second year Post Graduate, MDS, Department of Periodontics |
| Affiliation |
Nair Hospital Dental College |
| Address |
Room 202, Department of Periodontics, Nair Hospital Dental College,Mumbai Central, Mumbai, Maharashtra, INDIA
Mumbai (Suburban) MAHARASHTRA 400008 India |
| Phone |
9667896855 |
| Fax |
|
| Email |
srishtyesic@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Mala Dixit Baburaj |
| Designation |
Professor and Head of Department, Department of Periodontics |
| Affiliation |
Nair Hospital Dental college |
| Address |
Room 202, Department of Periodontics, Nair Hospital Dental College,Mumbai Central, Mumbai, Maharashtra, INDIA
Mumbai (Suburban) MAHARASHTRA 400008 India |
| Phone |
9223340938 |
| Fax |
|
| Email |
maladixit25@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Mala Dixit Baburaj |
| Designation |
Professor and Head of Department, Department of Periodontics |
| Affiliation |
Nair Hospital Dental College |
| Address |
Room 202, Department of Periodontics, Nair Hospital Dental College,Mumbai Central, Mumbai, Maharashtra, INDIA
Mumbai (Suburban) MAHARASHTRA 400008 India |
| Phone |
9223340938 |
| Fax |
|
| Email |
maladixit25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.srishty sharma room 202, department of Periodontics, Nair Hospital Dental College, A.L Nair road, Mumbai Central, Mumbai, Maharashtra- 400008, India |
|
|
Primary Sponsor
|
| Name |
Dr. Srishty Sharma |
| Address |
room 202, department of Periodontics, Nair Hospital Dental College,Mumbai Central, Mumbai, Maharashtra |
| 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 Srishty Sharma |
Nair Hospital Dental College |
room 202, department of Periodontics, Nair Hospital Dental College,Mumbai Central, Mumbai, Maharashtra Mumbai (Suburban) MAHARASHTRA |
9667896855
srishtyesic@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Nair Hospital Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Scaling and Root planing (SRP) with Photodynamic therapy with metal oxide |
Scaling and Root planing (SRP) with Photodynamic therapy with zinc oxide nanoparticles as an adjucnt to primary treatment.total Duration 3 months |
| Comparator Agent |
scaling and root planing with photodynamic therapy |
scaling and root planing along with photodynamic therapy as an adjuct to primary treatment. total duration is 3 months |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) systemically healthy adult patients
2)patients diagnosed with chronic periodontitis
3)patients with periodontal pocket greater than 3mm and less than 7mm
4)patient with no contraindication for laser
5)patient with informed consent and ready to comply with the treatment |
|
| ExclusionCriteria |
| Details |
1) Systemic diseases- active cancer, photodermatoses, photoallergies, encephalitis, meningitis, hyper/ hypo thyroidism.
2) Pregnancy.
3) Smoking
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Gingival index (Loe and Silness-1964)
2.Pocket Probing Depth
3.Plaque index (silness and loe)
4. Clinical Attachment level
5.Bleeding on probing
|
1) at baseline
2) 1 week
3) 1 month
4) 3 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| none |
none |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/11/2024 |
| Date of Study Completion (India) |
18/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
|
Periodontitis,
an inflammatory disease of the gums that destroys the foundation on which
teeth rest. Deterioration of periodontal ligaments (PDLs), the development of
periodontal pockets, and the resorption of alveolar bone are hallmarks.
Pockets may get infected with periodontitis because of the proliferation of
microflora, especially anaerobes, which cause a loss of clinical connection,
and the deterioration of alveolar bone [1]
Photodynamic
therapy (PDT) is a form of phototherapy involving photochemistry,
photophysics, and photobiology. PDT as a noninvasive method for tumor
treatment, differing from surgery, radiotherapy and chemotherapy, is less
toxic, short-term, non-resistant to the drug. Therefore, PDT has been already
applied in skin cancer , squamous cell carcinoma, prostate cancer, breast
cancer, cervical cancer, lung cancer , and much other cancer prevention and
treatment, which becomes more highly focused.[2]
It employs photosensitizers that are excited by appropriate
light in the presence of oxygen, to generate cytotoxic reactive oxygen
species (ROS), especially singlet oxygen. The ROS exerts toxic actions on
periodontal pathogens in either planktonic cultures or biofilm status to
substantially reduce the bacterial colonization without side effects and drug
resistance. effective for antibacterial treatment of deep periodontal
pockets, when excitation light with large penetration depth is involved to
trigger PDT effect, which is difficult to reach by mechanical approaches.[3]
The clinical evidence points out two significant limitations of
current phototherapeutic interventions: restricted penetration of
photosensitizer and light propagation inside the dentinal tubules, which
confines aPDT to marginal efficiency in vivo which are overcome by nano
platform based photosensitisers. The use of nano-based platforms to enhance
photosensitizers’ penetration . The application of nanoscale science has been
serving a link between engineering/technology and medicine/dentistry to
produce efficient platforms for the delivery of photosensitizers in target
dysbiotic biofilms which are located 5-7mm depth in pocket. The mobility and
bioavailability of nanoparticles will largely depend upon their diffusion
coefficients, which will be related to their size and physicochemical
characteristics, and the nature of the biofilm. Metallic nanoparticles have a
high surface-to-volume ratio, which guides the ability of such material to
interact with the bacterial membrane to induce bactericidal action [3 ]
Zinc is an indispensable trace element for humans and plays a
crucial role in regulating cellular metabolism and homeostasis. ZnO NPs can
be easily biodegraded and absorbed in the body and thus have been listed as
generally recognized as a safe (GRAS) material by the Food and Drug
Administration (FDA)[5]
ZnO nanoparticles are a newer type of promising candidate
because of its high safety, low price, lack of polluting effects, and good
stability against air and sunlight. the combination of their excellent
catalytical and antimicrobial properties together with their biocompatibility
makes ZnO nanostructures promising materials for tissue regeneration,
bacterial resistance, and wound dressing.
Zn 2+ ions released from ZnO nanostructures not only have the ability
to stimulate bone formation in vitro but can also enhance keratinocyte
migration toward a wound site and promote healing. the excellent electronic
properties of ZnO nanostructures make them suitable for the fabrication of
biosensors, and their unique photoluminescent properties, such as a tunable
emission wavelength, together with their high aqueous stability and high quantum
yield (QY) make ZnO-based quantum dots (QDs) promising candidates as
bioprobes for cell and tissue imaging [6]
zinc
oxide nanoparticles (ZnONPs), belonging to the family of semiconducting metal
oxide, are used as photosensitizers in aPDT. The photoresponse of ZnO
consists of two parts: a rapid process of photogeneration and recombination
of electron-hole pairs and a slow process attributed to the oxygen adsorption
and Photodesorption on the film surface as well as the grain boundaries. ZnO NPs,
such as the promising arrangement of its electronic structure, light
absorption properties, and charge transport characteristics, make it possible
to use it as a photosensitizer. ZnO NPs get photocatalyzed under both
ultra-violet and visible light irradiation, releasing ROS, which eventually
causes bacterial cell death [7]
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