Dental Implants Rehabilitation in Patients With Vitamin D3 Imbalance

NCT04841213 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 384

Last updated 2022-08-12

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04841213 on ClinicalTrials.gov