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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  
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 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  
Status 
Not Applicable 
 
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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