Clinical trial NCT06274216: The Effect of Vitamin D Supplementation on Dental Implant Osseointegration: A Randomized Controlled Trial
Official title: The Effect of Vitamin D Supplementation on Dental Implant Osseointegration: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osseointegration Failure of Dental Implant
Keywords: Dental implants
ISQ Value
Osseointegration
Vitamin D
Lead sponsor: Ziauddin University
Sponsor class: OTHER
First posted: 2024-02-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: SUPPORTIVE_CARE

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Osseo-integration is measured by evaluating the ISQ value (Implant Stability Quotient, ranging from 1-100)
timeFrame: 12 weeks
Secondary outcomes:
measure: Evaluation of Mean Change in Serum Vitamin D Levels in Dental Implant Patients with and without Vitamin D Supplementation at a Tertiary Care Hospital
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Afifa Razi
state: Sindh
Study officials:
References:
citation: 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.
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. doi: 10.1111/clr.13529. Epub 2019 Sep 24.
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.
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.
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.