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Completed

NCT Number: NCT06274216

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

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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Key information

Conditions

Osseointegration Failure of Dental Implant

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Afifa Razi

Karachi, Sindh, 74700, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D3

Drug

5000 IU of vitamin D3 orally every day for 12 weeks

Other names: Sunny-D

Vitamin E 400

Drug

400mg of vitamin E orally every day for 12 weeks

Other names: Evion

Primary outcomes

  1. Osseo-integration is measured by evaluating the ISQ value (Implant Stability Quotient, ranging from 1-100)

    Time frame: 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 outcomes

  1. Evaluation of Mean Change in Serum Vitamin D Levels in Dental Implant Patients with and without Vitamin D Supplementation at a Tertiary Care Hospital

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ziauddin University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 23, 2024
Registry last updated
Feb 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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