The Effect of Vitamin D Supplementation on Dental Implant Osseointegration: A Randomized Controlled Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2022-04-01

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Osseointegration Failure of Dental Implant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

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.

Study Groups

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Group A

Patients in group A received 5000 IU of vitamin D3 orally every day for 12 weeks

Group Type EXPERIMENTAL

Vitamin D3

Intervention Type DRUG

5000 IU of vitamin D3 orally every day for 12 weeks

Group B

Patients in group B received 400mg of vitamin E orally every day for 12 weeks

Group Type ACTIVE_COMPARATOR

Vitamin E 400

Intervention Type DRUG

400mg of vitamin E orally every day for 12 weeks

Interventions

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Vitamin D3

5000 IU of vitamin D3 orally every day for 12 weeks

Intervention Type DRUG

Vitamin E 400

400mg of vitamin E orally every day for 12 weeks

Intervention Type DRUG

Other Intervention Names

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Sunny-D Evion

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes