Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05956561 |
| Other study ID # |
EDIF 863 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 20, 2020 |
| Est. completion date |
April 29, 2023 |
Study information
| Verified date |
July 2023 |
| Source |
Ain Shams University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The goal of this observational study is to investigate relation between serum vitamin D
levels and early implant failure. in all patient seeking delayed dental implant placement at
Faculty of Dentistry, Ain Shams University from September 2020 to April 2023, all the
patients must fulfil the inclusion criteria including age above 18, no medical condition
interference and compliance to study. The main question[s] it aims to answer are:
- is vitamin D deficiency caustic to early implant failure
- can implant stability indicate implant failure Participants will receive implants and
prosthetic rehabilitated according to each case.
Description:
Brånemark discovered the process of osseointegration in the 1960s and placed the first dental
implant about 50 years ago. Since then dental implant became a basic alternative to
conventional prosthodontic treatment options. Many clinical studies on dental implants have
been published. Most studies present data on implant, prosthesis survival and on bone
response adjacent to the implants. However, only few studies have investigated whether there
is any possible correlation between serum levels of vitamin D and dental implant stability.
Osseointegration, the formation interface between implant and bone, is basic step of dental
implant success. Although it depends on variety of causes mention some of them: surgical and
prosthetic factors (surgical technique , operator experience, timing and type of prosthetic
loading, and quality of prosthetic rehabilitation), implant-related factors (material,
design, and surface), and patient-related factors (bone volume/quality at the recipient site
and host response ). Mechanical stability of dental implant is a prerequisite for successful
osseointegration. The alveolar bone architecture of the implant drilling site dictates the
success of anchored endosseous dental implants. Immediately and up to several months
afterwards, a series of cellular and molecular events occur where host tissues biologically
integrate the alloplastic material into the native bony structure. As cortical bone withstand
torsional loading and provides higher initial stability, cancellous bone is richer in
vascular canals and thus, vasculature to supply mesenchymal progenitor cells. In this sense,
the complex and dynamic process of osseointegration may occur via contact osteogenesis, where
the implant surface is surrounded by bone cells after fixation to form de novo bone, or via
distance osteogenesis, where bone formation is preceded by the osteoclastogenesis of the
existing tissue. Despite all improvements introduced mainly on surgical and prosthetic
protocols (design ,threads, micro- and nano-topographical (surface) treatments, and adding
growth factors) all of them and more improve dental implant survival rate, making it possible
to accomplish procedures were previously associated with high rate of failure as immediate
implant placement and immediate load of dental implant. Meanwhile with such improvement but
there are few percent of failure seem impossible to recognize its etiology. Based on
chronological criteria, failures can be classified as either "early dental implant failures"
(EDIFs) or "late dental implant failures" (LDIFs). EDIFs are due to unsuccessful
osseointegration, indicating impaired bone healing, whereas LDIFs are due to loss of
osseointegration. Both have different etiologies. LDIF is related to infection, occlusal
overloading, and failure of the implant components. EDIF is usually caused by inadequate
surgical and prosthetic protocols, low bone volume or quality at the recipient site, habits
(smoking and parafunctions), or systemic conditions endanger osseointegration. Early failures
due to lack of osseointegration are one of modern implantology nightmares. But as some
patient categories seem to be specific vulnerable to it more than else, it might be possible
to correlate it to patient's systemic health condition. Vitamin D is one of thi systemic
condition that may have impact on dental implant failure but barely mentioned in dental
literature. Today vitamin D is worldwide public health concern, vitamin D considered
deficient when serum 25(OH) levels are <10 ng/mL, insufficient when serum levels are 10-30
ng/mL, and optimal with serum levels of >30 ng/mL. Vitamin D deficiency can result from
inadequate dietary intake and insufficient exposure to sunlight. Vitamin D, fat-soluble
hormone regulates calcium phosphate homeostasis and mineral bone metabolism. It is
transformed into the active form (1, 25- dyhydroxy vitamin D3) by hydroxylation, firstly in
the liver then in the kidney. It stimulates osteoblast bone matrix production, coupling bone
resorption to form and optimize bone remodeling. As it increases calcium absorption in
intestine and so reduce PTH secretion and systemic bone resorption with a possible inhibition
of osteoclastogenesis. Vitamin D effect during dental implant osseointegration remains
limited in literature. In animals, Kelly et al. studied the osseointegration process in rats
with deficiency in Vitamin D and reported lower BIC values and mechanical bone strength after
2 weeks postimplant placement. Noteworthy that implant failure might be confounded by raise
insufficiency of vitamin D prevalence in populations. Zhou et al. reported titanium screw
fixation in rats after 8 weeks of oral treatment with vitamin D, with significant increment
of peri-implant bone density, bone-implant contact (1.5 times higher) and peri-implant
trabecular microarchitecture. Recently, topical application of vitamin D (10%) and melatonin
(5%) solutions on the surface of immediate implants placed in dogs evaluated. Both topical
applications significant improved new bone formation around implants and reduced crestal bone
loss at 12 weeks following surgery, standing out positive correlation between vitamin D and
early stages of osseointegration. Therefore, these results may suggest that vitamin D has
effect on bone healing after implant insertion. Schulze-Spate et al., in a randomized,
double-blind, placebo-controlled clinical trial in humans, reported finding a higher bone
remodeling activity related to higher vitamin D levels. A retrospective study correlate early
implant failure and low serum levels of vitamin D showed a higher incidence of the implant
failure rate but a correlation between both factors could not determine . Therefore, vitamin
D seems to improve bone health and implant healing. The present study will be selected from
those seeking delayed dental implant selected from those attending the outpatient clinic at
Oral and Maxillofacial Surgery Department in the Faculty of Dentistry, Ain Shams University
from February 2020 to February 2021. The following data will be collected from each patient
through diagnostic chart as follow: Personal data, chief complaint, full medical history,
dental history, family history and personal habits as smoking, alcohol consumption and habits
related to the oral hygiene. The study protocol will be explained to all prospective
candidates, and a written informed consent will be received from each patient before
participation. All the data will be reviewed by ethics commits of faculty of dentistry Ain
Shams University.
Eligibility criteria:
I. Inclusion criteria:
1. Patients with vitamin D sufficient, insufficient and deficient according to Enzyme
Immunoassay test.
2. Patients with horizontal ridge width and vertical ridge height, according to class III
of Cawood and Howell classification.
3. Patients with matched parameters of implant including diameter, length and
manufacturing.
4. Patients' compliance to oral hygiene measures.
5. Compliance with all requirements in the study and signing the informed consent.
6. Patient with sufficient inter arch space.
II. Exclusion criteria:
1. Patients with diseases of the immune system or any medical condition that may influence
the outcome.
2. Patients with history of intravenous and/or oral bisphosphonate use.
3. Pathologic lesions in the site of implant placement.
4. Patients who are pregnant or lactating mothers.
5. Smokers patients.
6. Patients with poor oral hygiene habits that are not amenable to motivation and
improvement.
7. Patients with history of irradiation of the head and neck region.
8. Patients who need pre-surgical augmentation for the alveolar ridge or sinus lift.
9. Patients need immediate implant placement. A-Pre-operative Phase 1- Clinical
examination:
- Clinical examination of the implant placement site for ensuring the health and
amount of soft tissue.
- Study models will have prepared and articulated to assess inter-arch space and
analyze the occlusion with respect to the site of the future implant. 2-
Radiographic examination:
- Cone Beam Computed Tomography (CBCT) will be done for each patient to evaluate the
alveolar ridge height and width at the site of implant placement. 3- Laboratory
investigation: 25-hydroxy vitamin D level will be done for each patient
preoperative using Enzyme Immunoassay (EIA) test categorized by mean serum vitamin
D status as follows: [26]
1. Sufficient, 25 (OH) D >30 ng/mL (>75 nmol/L)
2. Insufficient, 25 (OH) D 10-30 ng/mL (50-75 nmol/L)
3. Deficient, 25 (OH) D <10 ng/mL (<50 nmol/L). B- Surgical Phase
- All patients will receive dental implants under local anesthesia according to the
manufacturer drilling protocol.
- The initial implant stability will be analyzed using Osstell® in terms of ISQ
(Implant Stability Quotient) reading (R0). C-Post-operative Phase 1- Post-operative
instructions:
Will be given for each patient in a written manner as follow:
- To apply ice packs, wrapped in a cloth to avoid frostbite, on the surgical site
extra-orally for the first 24 hours (10 minutes every 30 minutes) to decrease edema.
- Following the first day, gentle rinsing by warm saline 3-5 times/day, for 1 week.
- To avoid vigorous gargling for the first 24 hours.
- To avoid hot food or drink for the first 24 hours. 2- Post-operative medications:
Amoxicillin/Clavulanic acid 875mg/125mg oral tablet (Augmantin®) will prescribed twice
daily for 5 days postoperatively (or Clindamycin 300 mg in patients allergic
to penicillin 3 times daily). [ Diclofenac potassium 50mg oral tablet (Cataflam®) three
times daily for 3 days, and then whenever it's needed for pain relief and
anti-inflammatory effect.
- Oral rinses with 0.125% Chlorohexidine HCL (Hexitol®) three times daily starting from
the second day postoperatively and continued for two successive weeks. 3- Post-operative
assessment:
- All patients will be recalled one week postoperatively to assess the overall healing
process and ensure good oral hygiene. The sutures will be removed at this appointment.
- 12 weeks postoperatively (R12), all patients will be recalled to reassess the implant
stability using Osstell® in terms of ISQ reading and each patient will receive the
healing abutment after an adequate healing period according to the site of the implant
in preparation for the prosthetic restoration.
- All patients will receive needed prosthetic restoration according to planned treatment
plane. All data will be tabulated for statistical analysis to correlate Vitamin D serum
level and ISQ readings (R0 and R12)
