Effect of Serum Vitamin D and Serum Calcium level on Stability of Dental Implant

Not yet recruiting

Conditions: Other Procedures, (2) ICD-10 Condition: E559||Vitamin D deficiency, unspecified,

Registration Number: CTRI/2020/06/025676

Lead Sponsor: Government Dental College and Hospital Nagpur

Brief Summary: Dental implants are now a reliable solution for thefunctional and aesthetic rehabilitation of partially and completely edentulouspatients. In order to achieve long term survival, osseointegration of dentalimplant needs to occur, that is, direct connection between the bone and implantsurface without interposition of the fibrous tissue.

Osseointegration is a complex phenomenon anddepends on many factors, some related to the implant (material, macroscopicdesign and implant surface)**,**some to the surgical prostheticprotocol (surgical technique, loading conditions and time) and others topatient (quantity and quality of bone at the receiving site and the hostresponse)

In spite of the high survival rate ofimplant, early failures occur even when optimal materials are used, surgicalprotocols are strictly followed and the quantity/quality of bone at recipientsite is sufficient.

All these observations would suggest theexistence of specific patient related risk factors, this promotes aninvestigation into regulatory mechanisms controlling bone metabolism, boneremodeling and bone turnover.

Vitamin D plays a fundamental role in bonemetabolism. It is a fat soluble vitamin which promotes the absorption ofcalcium in the intestine and regulates calcium and phosphate homeostasis in thetissues and fundamental element in mineralization of bones and teeth. Itstimulates the activity of osteoclasts and increases the production ofextracellular matrix proteins by osteoblasts. It also plays a role in innateand adaptive immune response.

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

The purpose of this study isto investigate correlation between levels of Serum Vitamin D and Serum Calciumon stability of implant.

**Review of literature**

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

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

3. Kelly et al (2009) demonstrated that vitamin D deficiencycould significantly compromise the establishment of osseointegration of Ti6Al4Vimplants in rats.

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

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

6. Bashutski JD**et al**(2011) concluded that Vitamin D deficiency atthe time of periodontal surgery negatively affects periodontal treatmentoutcomes for up to 1 yr and Vitamin D status may be critical for post-surgicalhealing.

7. Choukroun J**et al**(2014) suggested exploration of vitamin D serumlevel and LDL Cholesterol in the case of a failure of a bone graft orimplant placement.

8. Fretwurst T**et al**(2016) illustrated two case reports withvitamin D deficiency and early implant failure and further concluded thatProspective, randomized clinical trials must follow to affirm the relationshipbetween vitamin D deficiency, osteoimmunology, and early implant failure.

9. Wagner F et al (2017) stated that there is nocontraindication to place dental implants in osteoporotic patients althoughosteoporosis significantly influence the peri-implant bone remodelling.

10. SalomÃ³**â€****Coll O****et al**(2016) concluded that With the limitation of animal studies,topical application of vitamin D on dental implants could reduce crestal boneloss and increase 10% more boneâ€toâ€implant contact at 12â€week followâ€up period.

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

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

13. **Sennerby et al**(2000)The resonance frequency analysis techniquecan supply clinically relevant information about the state of the implantâ€“boneinterface 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 posean increased risk for failure compared with implants with high and/orincreasing values.

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

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

Adult male or female patients in the age range of 18-60 years.
Patients planned for two staged implant treatment in the mandibular posterior region.

Exclusion Criteria

Implants placed with procedures involving ridge expansion, ridge augmentation and sinus lift procedure.
Untreated medical or psychiatric problem, compromised immune system, pregnancy or lactation.
Patients on Vitamin D and Calcium supplement in past 6 months.
Past or present treatment with intravenous amino-bisphosphonates.
Poor oral hygiene and/or motivation, heavy smokers.
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.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Stability of dental implant at second stage of dental implant surgery by Resonance frequency analysis.	1. 3 months after implant placement. \| 2. 3 months after implant placement.
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 Measures

Name	Time	Method
1. Presence or absence of suppuration.	2. Presence or absence of soft tissue dehiscence over the implanted site.

Trial Locations

Locations (1): Government Dental College and Hospital, Nagpur
🇮🇳
Nagpur, MAHARASHTRA, India
Government Dental College and Hospital, Nagpur
🇮🇳Nagpur, MAHARASHTRA, India
Dr Vaishnavi Ramakant Chodankar
Principal investigator
09821877904
vaishu2528@gmail.com