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Osseointegration Failure of Dental ImplantNCT06274216

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

A study testing Vitamin D3 and Vitamin E 400 in people with Osseointegration Failure of Dental Implant, run by Ziauddin University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
What is being tested?
Vitamin D3 and Vitamin E 400
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 sitePakistan
Study dates
1 Sep 2021to 1 Apr 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Patients of age 18 to 45 years
  • Patients of either gender
  • Patients undergoing for dental implant
  • Patients with Vitamin-D insufficiency

Who cannot join

  • 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
Show all 10Show fewer
  • Patients with severe vitamin D deficiency
  • Patients with chronic renal disease
  • Patients on proton pump inhibitors
  • Pregnant women

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Afifa Razi

    Karachi, Sindh, 74700

Other trials in Pakistan

About this study

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

Read the 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.

Being tested
Vitamin D3, Vitamin E 400
Keywords
Dental implants, ISQ Value, Osseointegration, Vitamin D

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vitamin D3Drug

    Also called Sunny-D

    5000 IU of vitamin D3 orally every day for 12 weeks

  • Vitamin E 400Drug

    Also called Evion

    400mg of vitamin E orally every day for 12 weeks

Study groups in NCT06274216
Study groupRoleWhat they receive
Group AExperimentalPatients in group A received 5000 IU of vitamin D3 orally every day for 12 weeks
Receives: Drug: Vitamin D3
Group BActive comparatorPatients in group B received 400mg of vitamin E orally every day for 12 weeks
Receives: Drug: Vitamin E 400

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: 12 weeks

Secondary outcomes (1)

  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

    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.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2024
  2. Study start1 Sep 2021
  3. Primary completion30 Mar 2022
  4. Study completion1 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
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
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06274216
Sponsor's protocol ID
4381021ABOS
Status last verified
Feb 2024
First submitted
18 Jan 2024
Last updated
23 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • Alsulaimani L, Alqarni A, Almarghlani A, Hassoubah M. The Relationship Between Low Serum Vitamin D Level and Early Dental Implant Failure: A Systematic Review. Cureus. 2022 Jan 15;14(1):e21264. doi: 10.7759/cureus.21264. eCollection 2022 Jan.

    PubMed 35178319

  • Munhoz Pereira T, Alvim-Pereira F, Kaiser Alvim-Pereira CC, Ignacio SA, Machado de Souza C, Trevilatto PC. A complete physical mapping of the vitamin D receptor gene for dental implant loss: A pilot study. Clin Oral Implants Res. 2019 Dec;30(12):1165-1178. doi: 10.1111/clr.13529. Epub 2019 Sep 24.

    PubMed 31461186

  • Tabrizi R, Mohajerani H, Jafari S, Tumer MK. Does the serum level of vitamin D affect marginal bone loss around dental implants? Int J Oral Maxillofac Surg. 2022 Jun;51(6):832-836. doi: 10.1016/j.ijom.2021.11.006. Epub 2021 Dec 3.

    PubMed 34872836

  • Werny JG, Sagheb K, Diaz L, Kammerer PW, Al-Nawas B, Schiegnitz E. Does vitamin D have an effect on osseointegration of dental implants? A systematic review. Int J Implant Dent. 2022 Apr 11;8(1):16. doi: 10.1186/s40729-022-00414-6.

    PubMed 35403929

  • Pourshahidi S, Yousefain M. The Relationship Between Serum Level of Vitamin D3 and Osseointegration Around the Dental Implant. J Oral Implantol. 2021 Feb 1;47(1):88-90. doi: 10.1563/aaid-joi-D-19-00341.

    PubMed 32663271

Questions about this trial

What is this clinical trial studying?

A study testing Vitamin D3 and Vitamin E 400 in people with Osseointegration Failure of Dental Implant, run by Ziauddin University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Osseo-integration is measured by evaluating the ISQ value (Implant Stability Quotient, ranging from 1-100) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06274216, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.

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