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

February 22, 2024 updated by: Dr. Atif Iqbal, Ziauddin University
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 74700
        • Afifa Razi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Patients in group A received 5000 IU of vitamin D3 orally every day for 12 weeks
Drug: Vitamin D3
5000 IU of vitamin D3 orally every day for 12 weeks
Other Names:
  • Sunny-D
Active Comparator: Group B
Patients in group B received 400mg of vitamin E orally every day for 12 weeks
Drug: Vitamin E 400
400mg of vitamin E orally every day for 12 weeks
Other Names:
  • Evion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ziauddin University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Actual)

March 30, 2022

Study Completion (Actual)

April 1, 2022

Study Registration Dates

First Submitted

January 18, 2024

First Submitted That Met QC Criteria

February 22, 2024

First Posted (Estimated)

February 23, 2024

Study Record Updates

Last Update Posted (Estimated)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4381021ABOS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The informed consent process typically outlines the extent to which data will be shared. If participants were not informed about individual data sharing, it may be ethically inappropriate to do so.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Osseointegration Failure of Dental Implant

Clinical Trials on Vitamin D3

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Costa Rica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe