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CTRI Number  CTRI/2024/02/063034 [Registered on: 22/02/2024] Trial Registered Prospectively
Last Modified On: 21/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Topical application of UV-irradiated "Vitamin D" on implant surface during implantation for the evaluation of Osteoprotegerin (OPG) and implant stability: A Randomized control study 
Scientific Title of Study   Assessment of Osteoprotegerin (OPG) and implant stability through the Topical application of UV irradiated Vitamin D on implant surface during placement :A Randomized controlled clinical 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  Ruby Singh 
Designation  Junior Resident 
Affiliation  King Georges medical university 
Address  sixth floor , Department of Prosthodontics, crown and Bridges. Faculty of dental sciences King Georges medical university
Room no. 106 A block gautam buddha hostel shah mina road
Lucknow
UTTAR PRADESH
226003
India 
Phone  8004504669  
Fax    
Email  ruby17993@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jitendra Rao 
Designation  Professor 
Affiliation  King Georges medical university 
Address  sixth floor , Department of Prosthodontics, crown and Bridges. Faculty of dental sciences King Georges medical university

Lucknow
UTTAR PRADESH
226003
India 
Phone  9415576398  
Fax    
Email  drjit123@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ruby Singh 
Designation  Junior Resident 
Affiliation  King Georges medical university 
Address  sixth floor , Department of Prosthodontics, crown and Bridges. Faculty of dental sciences King Georges medical university
Room no. 106 A block gautam buddha hostel shah mina road
Lucknow
UTTAR PRADESH
226003
India 
Phone  8004504669  
Fax    
Email  ruby17993@gmail.com  
 
Source of Monetary or Material Support  
king georges medical university 
 
Primary Sponsor  
Name  King georges medical university 
Address  Seminar room, sixth floor Department of Prosthodontics, crown & bridge, New dental building chowk, lucknow 
Type of Sponsor  Government medical college 
 
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 Ruby Singh  King georges medical university,  Seminar room, sixth floor Department of Prosthodontics, crown & bridge, New dental building
Lucknow
UTTAR PRADESH 
8004504669

ruby17993@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  missing teeth in maxillary jaw  
Patients  (1) ICD-10 Condition: K068||Other specified disorders of gingiva and edentulous alveolar ridge,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  no coating of implant surface  no coating of implant surface 
Intervention  vitamin D  for implant placement in test group Prophylactic antibiotic coverage of 2 gm Amoxycillin will be given to all the subjects 1 hour before the procedure. After local anesthesia will be induced with 2% lignocaine with adrenaline (LOX 2% Adrenaline), a crestal incision will be made and the mucoperiosteal flap will be raised, after that UV irradiated topical Vitamin D of 6000000 IU will be coated on implant surface and implants will be placed according to recommendations given by manufacturer and gingival former will be placed.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients with edentulous space in the
maxillary jaw having healed bone site
indicated for rehabilitation with
implants.
2. Patient having sufficient residual bone
volume for implant placement.
3. Patient having good general health with no
systemic disease.
4. Patient having adequate oral hygiene.
5. Good general and periodontal health.
 
 
ExclusionCriteria 
Details  1. Patients who consume alcohol, smoke or use illicit drugs.
2. Patient with any systemic disease, irradiated patients, patients with previous or active treatments with steroids or bisphosphonates
3. Pregnant/lactating women
4. Systemic diseases which can affect bone metabolism such as osteoporosis and endocrine diseases
5. Patients taking antibiotics/steroids/anti inflammatory for the past 3 months.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
osteoprotegerin biomarker

 

0 weeks, 2 weeks, 12 weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
implant stability
crestal bone loss 
0 weeks, 2 weeks, 12 weeks, 6 months 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   15/03/2024 
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 Yet Recruiting 
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  

Dental implants have revolutionized oral rehabilitation, after 10 years of continuous follow-up, it found that success rate of dental implants is 95%. Osteoprotegerin (OPG) and receptor activator of nuclear factor kappa B ligand (RANKL) are osteoblast-derived factors that compete for binding to the same RANK receptor location and have regulating effects on osteoclastogenesis.   Osteoprotegerin belongs to the tumor necrosis factor receptor superfamily and it encodes for type I transmembrane glycoproteins.  Osteoprotegerin (OPG), also referred to as osteoclast inhibiting factor, is a soluble decoy receptor that can be located in the body. In growing bone, OPG amounts are high and its expression is increased by bone morphogenetic protein (BMP), IL1, TNF, TGF and estrogen. Biochemical changes can be achieved by topically applying biological mediators to the device surface and by applying substances with systemic effects, such as bisphosphonates. (5,6) The term "Vitamin D" applies to a class of vitamin kinds derived from fatty steroid hormones. Ergocalciferol and cholecalciferol are two forms of   Vitamin   D.   Calcitriol, another name for Vitamin D3, is the most active type of Vitamin D and is synthesized when skin cholesterol is exposed to UV radiation. Vitamin D plays a crucial part in maintaining the biological equilibrium of bone and calcium because it directly contributes to calcium absorption in the body. Additionally, this molecule decreases calcium and phosphorus loss while increasing bone reabsorption.  osteoblasts cells contain Vitamin D receptors. The production of genes is also regulated by Vitamin D. The effectiveness of tooth implants is significantly influenced by implant stability. Implant stability can be divided into two categories: biological stability, which results from osseointegration, and mechanical stability, which happens between the implant and bone. Collagen fibers, carbohydrates, cells, and calcium, which comprise the four main components of bone. Remodeling and hardening of bone occur constantly. Remodeling may be mechanical, medical, or biochemical. Following the stretching of the periodontal ligament fibers caused by the application of an orthodontic force, regions of compression and strain form. Osteoblastic activity can be seen in areas of strain while osteoclastic activity can be seen in regions of compression. 

Aim of the study is to Evaluation of salivary Osteoprotegerin (OPG) through UV irradiated topical application of Vitamin D on implant surface during placement.

 
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