Dental Implants Rehabilitation in Patients With Vitamin D3 Imbalance
NCT04841213 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 384
Last updated 2022-08-12
Summary
Interventional retrospective prospective randomized clinical trial (RCT) in parallel groups.
The sample size is 384 patients with loss of teeth and vitamin D imbalance. All patients will undergo or underwent dental implantation after additional investigations which reveal vitamin D imbalance (\<30 ng/ml or \<75 nmol/l).
The 1 group will include 192 patients who will be or were operated on with dental implants after stabilization of vitamin D level with a help of an endocrinologist.
The 2 group will include 192 patients who will be or were operated on during the treatment of vitamin D imbalance prescribed by the endocrinologist.
The possible difference between groups can be considered the change of dental implants survival time and bone resorption level depending on the level of vitamin D and treatment time by the endocrinologist.
Conditions
- Tooth Loss
- Vitamin D3 Deficiency
- Osteomalacia
Interventions
- PROCEDURE
-
Dental implantation
Traditional 2-stage dental implantation according to surgical protocols of dental implant systems (Straumann (Institut Straumann AG, Switzerland), Astra Tech (Dentsply Implant Manufacturing GmbH, Germany), Xive (FRIADENT GmbH, Germany), Alpha Bio (Alpha Bio Tec Ltd., Israel) for different types of bone tissue
Sponsors & Collaborators
-
I.M. Sechenov First Moscow State Medical University
lead OTHER
Principal Investigators
-
Ekaterina Diachkova, PhD · I.M.Sechenov First Moscow State Medical University (Sechenov University)
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 25 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-04-10
- Primary Completion
- 2022-04-10
- Completion
- 2022-08-01
Countries
- Russia
Study Locations
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