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

Osseointegration Failure of Dental Implant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06274216
• Other study ID #: 4381021ABOS
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: April 1, 2022

Study information

• Verified date: February 2024
• Source: Ziauddin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The long-term success of dental implants would also be enhanced and preserved with the right medical use of vitamin D

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 1, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Osseointegration Failure of Dental Implant

Intervention

Drug:
• Vitamin D3
5000 IU of vitamin D3 orally every day for 12 weeks
• Vitamin E 400
400mg of vitamin E orally every day for 12 weeks

Locations

Country	Name	City	State
Pakistan	Afifa Razi	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Ziauddin University

Country where clinical trial is conducted

Pakistan, 

References & Publications (5)

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. — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks
Secondary	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.	12 weeks