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

NCT06274216 | Completed DMC

• 1 other identifier: 4381021ABOS
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Osseointegration Failure of Dental Implant

Keywords

Dental implants; ISQ Value; Osseointegration; Vitamin D

Outcome Measures

Primary Outcomes (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.

  12 weeks

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

  12 weeks

Study Arms (2)

Group A

EXPERIMENTAL

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

Drug: Vitamin D3

Group B

ACTIVE COMPARATOR

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

Drug: Vitamin E 400

Interventions

Vitamin D3 DRUG

5000 IU of vitamin D3 orally every day for 12 weeks

Also known as: Sunny-D

Group A

Vitamin E 400 DRUG

400mg of vitamin E orally every day for 12 weeks

Also known as: Evion

Group B

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ziauddin University: lead

Study Sites (1)

Afifa Razi

Karachi, Sindh, 74700, Pakistan

Location

Related 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.

  PMID: 35178319 RESULT

• 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.

  PMID: 31461186 RESULT

• 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.

  PMID: 34872836 RESULT

• 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.

  PMID: 35403929 RESULT

• 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.

  PMID: 32663271 RESULT

MeSH Terms

Interventions

Cholecalciferol; Tocopherols

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Vitamin E; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: February 23, 2024
• Study Start: September 1, 2021
• Primary Completion: March 30, 2022
• Study Completion: April 1, 2022
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)