Osseointegration Failure of Dental Implant
Conditions
Keywords
Dental implants, ISQ Value, Osseointegration, Vitamin D
Brief summary
Dental implantation is a new technique for the single or more missing tooth replacement. Dental professionals might utilize the findings of this investigation to generate local data and learn more about how vitamin D affects bone metabolism and implant osseo-integration. The long-term success of dental implants would also be enhanced and preserved with the right medical use of vitamin D
Detailed description
Treatment option for replacing lost natural teeth is dental implants. Many factors are essential for the dental implant osse-ointegration, consisting of bone quality and volume, surgical approach and complications and host-associated factors like deficient nutritional status. By influencing bone metabolism, vitamin D, together with calcium, is essential for osseo-integrating implants. The significance of vitamin D supplementation in osseo-integration has received little attention in dental literature; there is little data involving people, and the majority of investigations have used animal models. Due to numerous environmental and dietary factors, international data is not applicable to our population. Latest study shows that 54% of the individuals were vitamin D deficient and 31% had vitamin D insufficiency in Pakistan.(Riaz et al., 2016) As well as Pakistani are less likely to expose to sun due to their full clothing, use of veil and Burqah. This research was therefore assessed the impact of vitamin D supplementation during dental implant osseointegration. In this research, the local data have been generated and dental implants in the presence of vitamin-D supplementation were tested for effectiveness.
Interventions
DRUGVitamin D3
5000 IU of vitamin D3 orally every day for 12 weeks
DRUGVitamin E 400
400mg of vitamin E orally every day for 12 weeks
Sponsors
Ziauddin University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Masking description
Groups A and B were created out of all patients who had signed up. Patients in group A received 5000 IU of vitamin D3 orally every day for 12 weeks , whereas patients in group B received a placebo. Patients were blinded to the study medication. The implants were then allowed to cure adequately and submerged for a further three months. Patients were summoned back three months later to un-cover the implant. The both groups were compared for the difference of osseo-integration at 3 months, as well as difference of osseo-integration were compared with respect to implant site (maxilla and mandible). Additionally, change in vitamin D levels were also assessed pre-operatively and post-operatively at 3 months.
Intervention model description
The research commences through a self-administered questionnaire such as age, gender, weight, height, BMI, smoking habits, sun exposure, and employment status. Prior to implant surgery, each participant undergoes a blood test to assess their vitamin D levels. Detailed records are maintained concerning the anatomical position (molar, pre-molar, canine, and incisor) and implant site (maxilla and mandible) for every participant. Group Formation: The participant pool is stratified into two distinct groups - Group A and Group B. This categorization is essential for implementing and comparing different interventions within the study. Group A undergoes a specific intervention wherein they receive a daily oral dose of 5000 IU of vitamin D3 for a duration of 12 weeks. In contrast, Group B receives a placebo. Following the intervention period, the implants are allowed to cure adequately
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
Patients of age 18 to 45 years * Patients of either gender * Patients undergoing for dental implant * Patients with Vitamin-D insufficiency
Exclusion criteria
Patients with any bone regenerative therapy prior to dental implants * Patients with arthritis * Patients with periodontal disease * Patients with bleeding disorders * Patients with poor oral hygiene * Patients with uncontrolled hypertension and diabetes mellitus * Patients with severe vitamin D deficiency * Patients with chronic renal disease * Patients on proton pump inhibitors * Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Osseo-integration is measured by evaluating the ISQ value (Implant Stability Quotient, ranging from 1-100) | 12 weeks | It will assess the difference in osseo-integration among patients undergoing dental implant procedures. Osseo-integration is measured by evaluating the ISQ value (Implant Stability Quotient, ranging from 1-100) using radiographic and clinical assessments with Ostell. A higher ISQ value indicates greater stability of the dental implants in the surrounding bone tissue. The assessment is conducted three months post-implantation, following a period of implant curing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Mean Change in Serum Vitamin D Levels in Dental Implant Patients with and without Vitamin D Supplementation at a Tertiary Care Hospital | 12 weeks | The secondary outcome in this study is to measure the mean change in serum vitamin D levels in both groups. This involves assessing how the serum vitamin D levels evolve over the course of the study in both the group receiving vitamin D supplementation and the group receiving a placebo. |
Countries
Pakistan
Outcome results
None listed