FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/06/025676 [Registered on: 08/06/2020] Trial Registered Prospectively
Last Modified On: 04/06/2020
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Effect of Serum Vitamin D and Serum Calcium level on Stability of Dental Implant 
Scientific Title of Study   Determination of association of Serum Vitamin D and Serum Calcium level for Stability of Dental Implant at Second stage of Implant surgery- Cross sectional Study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vaishnavi Ramakant Chodankar 
Designation  Postgraduate student 
Affiliation  Government Dental College and Hospital, Nagpur 
Address  Room No 202, Department of Periodontology, 2nd floor, Government Dental College and Hospital Nagpur, Opposite MARD Canteen,Medical Square, Nagpur

Nagpur
MAHARASHTRA
440003
India 
Phone  09821877904  
Fax    
Email  vaishu2528@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Vaibhav Karemore 
Designation  Associate Professor 
Affiliation  Government Dental College and Hospital, Nagpur 
Address  Room No 212, Department of Periodontology, 2nd floor, Government Dental College and Hospital Nagpur, Opposite MARD Canteen,Medical Square, Nagpur

Nagpur
MAHARASHTRA
440003
India 
Phone  09011098882  
Fax    
Email  drperiodon@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Vaishnavi Ramakant Chodankar 
Designation  Postgraduate student 
Affiliation  Government Dental College and Hospital, Nagpur 
Address  Room No 202, Department of Periodontology, 2nd floor, Government Dental College and Hospital Nagpur, Opposite MARD Canteen,Medical Square, Nagpur

Nagpur
MAHARASHTRA
440003
India 
Phone  09821877904  
Fax    
Email  vaishu2528@gmail.com  
 
Source of Monetary or Material Support  
Department of Periodontology, Government Dental College and Hospital Nagpur, Opposite MARD canteen, Medical square, Nagpur 440003 
 
Primary Sponsor  
Name  Government Dental College and Hospital Nagpur 
Address  Government Dental College and Hospital Nagpur, opposite MARD canteen, Medical square, Nagpur 440003 
Type of Sponsor  Other [Government Dental 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 Vaishnavi Ramakant Chodankar  Government Dental College and Hospital, Nagpur  Room No 202, Department of Periodontology, 2nd floor, Government Dental College and Hospital Nagpur, Opposite MARD Canteen, Medical square, Nagpur 440003
Nagpur
MAHARASHTRA 
09821877904

vaishu2528@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee,Government Dental College and Hospital, Nagpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 8||Other Procedures, (2) ICD-10 Condition: E559||Vitamin D deficiency, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Adult male or female patients in the age range of 18-60 years.
2. Patients planned for two staged implant treatment in the mandibular posterior region 
 
ExclusionCriteria 
Details  1. Implants placed with procedures involving ridge expansion, ridge augmentation and sinus lift procedure.
2. Untreated medical or psychiatric problem, compromised immune system, pregnancy or lactation.
3. Patients on Vitamin D and Calcium supplement in past 6 months.
4. Past or present treatment with intravenous amino-bisphosphonates.
5. Poor oral hygiene and/or motivation, heavy smokers.
6. Any local factors like:-
a. Inadequate bone quantity and quality at prospective implant site
b. Signs of local inflammation or unhealed extraction sockets
c. Untreated periodontitis
d. History of chemotherapy
e. Patients with bruxism 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Stability of dental implant at second stage of dental implant surgery by Resonance frequency analysis.
2.Serum Vitamin D and Serum Calcium level at second stage of implant surgery 
1. 3 months after implant placement.
2. 3 months after implant placement. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Presence or absence of suppuration.
2. Presence or absence of soft tissue dehiscence over the implanted site.
3. Tenderness at the implant site.
4. Crestal bone level.
5. Peri-implant Radiolucency 
3 months after implant placement 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   10/06/2020 
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="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Mangano F, Mortellaro C, Mangano N, Mangano C. Is low serum vitamin D associated with early dental implant failure? A retrospective evaluation on 1625 implants placed in 822 patients. Mediators of inflammation. 2016;2016. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

        Dental implants are now a reliable solution for the functional and aesthetic rehabilitation of partially and completely edentulous patients. In order to achieve long term survival, osseointegration of dental implant needs to occur, that is, direct connection between the bone and implant surface without interposition of the fibrous tissue.

        Osseointegration is a complex phenomenon and depends on many factors, some related to the implant (material, macroscopic design and implant surface)some to the surgical prosthetic protocol (surgical technique, loading conditions and time) and others to patient (quantity and quality of bone at the receiving site and the host response)

         In spite of the high survival rate of implant, early failures occur even when optimal materials are used, surgical protocols are strictly followed and the quantity/quality of bone at recipient site is sufficient.

        All these observations would suggest the existence of specific patient related risk factors, this promotes an investigation into regulatory mechanisms controlling bone metabolism, bone remodeling and bone turnover.

        Vitamin D plays a fundamental role in bone metabolism. It is a fat soluble vitamin which promotes the absorption of calcium in the intestine and regulates calcium and phosphate homeostasis in the tissues and fundamental element in mineralization of bones and teeth. It stimulates the activity of osteoclasts and increases the production of extracellular matrix proteins by osteoblasts. It also plays a role in innate and adaptive immune response.  

        Importance of Vitamin D and its effects on bone metabolism is known but very few studies have investigated the effects of its depletion on stability of dental implants. Almost all studies have been done on animal models. Unfortunately very few prospective clinical studies have so far investigated the effects of vitamin D deficiency on osseointegration and stability of implant in humans.

          The purpose of this study is to investigate correlation between levels of Serum Vitamin D and Serum Calcium on stability of implant.

 

Review of literature      

1. Mangano et al (2016) carried out a retrospective clinical study to investigate if there is a link between low levels of vitamin D in blood and increased implant failures and found an increasing trend in incidence of early implant failure with worsening of Vitamin D deficiency but failed to prove an effective link between low serum levels of vitamin D and increased risk of early implant failure.

2. In orthopaedics, Maier G S et al (2014) founded the risk to develop a peri-prosthetic joint infection has been associated with a low vitamin D level.

3. Kelly et al (2009) demonstrated that vitamin D deficiency could significantly compromise the establishment of osseointegration of Ti6Al4V implants in rats.

4. Dvorak et al (2011) found Vitamin D deficiency has a negative impact on peri-implant bone formation in ovariectomized rats, which can be compensated by Vitamin D supplementation.

5. Zhou et al (2012) concluded that 1,25(OH)2D3 improves implant osseointegration in osteoporotic rats.

6. Bashutski JD et al (2011) concluded that Vitamin D deficiency at the time of periodontal surgery negatively affects periodontal treatment outcomes for up to 1 yr and Vitamin D status may be critical for post-surgical healing.

7. Choukroun J et al (2014) suggested exploration of vitamin D serum level and LDL Cholesterol  in the case of a failure of a bone graft or implant placement.

8. Fretwurst T et al (2016) illustrated two case reports with vitamin D deficiency and early implant failure and further concluded that Prospective, randomized clinical trials must follow to affirm the relationship between vitamin D deficiency, osteoimmunology, and early implant failure.

9. Wagner F et al (2017) stated that there is no contraindication to place dental implants in osteoporotic patients although osteoporosis significantly influence the peri-implant bone remodelling.

10. Salomó‐Coll O et al (2016) concluded that With the limitation of animal studies, topical application of vitamin D on dental implants could reduce crestal bone loss and increase 10% more bone‐to‐implant contact at 12‐week follow‐up period.

11. Trindade R et al (2015) concluded that Osseointegration of implant devices may also be affected potentially by bone cells and mediators that populate the osseous tissue.

12. Swami et al (2016) stated that RFA can be used to evaluate the effect of early and delayed loading, assess stability over a period of time and early diagnosis of implant failure.

13. Sennerby et al (2000)The resonance frequency analysis technique can supply clinically relevant information about the state of the implant–bone interface at any stage of the treatment or at follow-up examinations.

14. Sennerby L et al (2015) stated that implants with low and/or falling ISQ values pose an increased risk for failure compared with implants with high and/or increasing values.

15. Becker W et al (2018) compared two clinical instruments for resonance frequency analysis and found that Penguin RFA was less cumbersome to utilize and the window revealing the readings was very easier to read.

 

 
Close