| 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
|
|
|
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
|
|
|
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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