Dental Implants Rehabilitation in Patients With Vitamin D3 Imbalance
Condition: Tooth Loss; Vitamin D3 Deficiency; Osteomalacia
MeSH terms: Osteomalacia; Tooth Loss
Study type: Interventional

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.
    

Detailed description: 
      A purpose is to increase the efficiency of rehabilitation of patients with loss of teeth and
      mineral metabolism disorders due to vitamin D3 imbalance using an interdisciplinary approach
      to dental implantation.

      Retrospective prospective RCT in parallel groups includes 384 patients with loss of teeth and
      vitamin D3 imbalance who will undergo or underwent the dental implantation on the base of
      Oral Surgery Department of Borovskiy Institute of Dentistry of I.M.Sechenov First Moscow
      State Medical University (Sechenov University) and private dental clinic 'Society with
      limited responsibility (SLR) Topaz 2000' from 2010 till the 2021 year: prospective part will
      include 100 patients, the retrospective part will include 284 patients.

      The counted sample size according to loss of teeth prevalence in Russia on the base of
      Sechenov University and private dental clinic Topaz 2000 is equal to 384 patients.

      Randomization will be assured by surgeons blinded to endocrinologic status of patients who
      underwent or will undergo the dental implantation.

      All patients will be included in 2 groups: 1 group will include patients (n=192),
      25-50-years-old, with loss of teeth and mineral metabolism disorders due to vitamin D3
      imbalance (<30 ng/ml, or <75 nmol/l) who will undergo dental implant placement after
      stabilization of vitamin D3 levels (>30-60 ng/ml, or 75-150 nmol/l for the process of
      treatment and monitoring); 2 group will include patients, 25-50-years-old, with the loss of
      teeth and mineral metabolism disorders due to vitamin D3 imbalance (n=192) who will undergo
      the dental implantation during treatment by an endocrinologist before the stabilization of
      vitamin D3 level in the blood.

      Group 1

      Patients will be directed for lab tests to detect mineral imbalance (vitamin D, ng/ml;
      parathyroid hormone (PH), thyroperoxidase antibodies (anti-TPO), Thyrotoxin 3 free (TT),
      Thyrotropic hormone (TH) pg/l) before dental implantation, and according to results, we will
      discuss further plan treatment with the endocrinologist. If it is needed due to the
      indications (adults with osteoporotic fractures; adults with a disease or condition
      accompanied by reduced bone mass or bone loss; all persons in the appointment of drug
      therapy, iatrogenic in relation to loss of bone mass; all patients receiving anti-osteopathic
      treatment to monitor its effectiveness; all persons who are not yet receiving treatment, but
      who may need it in case of bone loss.), Dual-Energy X-Ray Absorptiometry (DEXA) of skeleton
      mineral bone density will be done. After appropriate systemic treatment with vitamin D3 in 2
      months after stabilization (>30 ng/ml, or >75 nmol/l) ) of vitamin D3 level (Aquadetrim
      (cholecalciferol) 15000 International Units (IU), Medana Pharma S.A., Poland, Registration
      number P N014088/01 from 21st June 2017; first 2 months taking orally 2-5 drops with a spoon
      of water depending on the severity of diseases, after 2 months and reaching the reference
      level of vitamin D its dose will be 1 drop per a day whole period of monitoring) the dental
      implantation was and will be performed with the further control of bone density and
      peri-implant tissues in 3 months after the operation. In the case of low bone density (type 3
      or 4) the additional bone plasty was and will be performed. we assess the stability of dental
      implant on the stages of prosthetic rehabilitation according to the force of osteointegration
      during the inserting of the healing abutment (in Newtons on square centimeter), and each 1
      year after treatment in the condition of periodical monitoring of patients with the
      endocrinologist (after the beginning of treatment after 2 months, then 1 time per 6 months).

      Traditional 2-stage dental implantation will be performed according to surgical protocols of
      dental implant systems (Straumann (Institut Straumann AG, Switzerland, registration in Russia
      03/10/2017 No FSZ 2010/06855), Astra Tech (Dentsply Implant Manufacturing GmbH, Germany,
      registration in Russia 27/09/2018 No FSZ 2008/02570), Xive (FRIADENT GmbH, Germany,
      registration in Russia 09/09/2008 No FSZ 2008/02568), Alpha Bio (Alpha Bio Tec Ltd., Israel,
      registration in Russia 26/04/2017 No FSZ 2009/05582), for different types of bone tissue

      Group 2

      Patients will be directed for lab tests to detect mineral imbalance (vitamin D, ng/ml; PH,
      anti-TPO, TT, TH, pg / l) before dental implantation, and according to results, we will
      discuss further plan treatment with the endocrinologist. If it is needed due to the
      indications (adults with osteoporotic fractures; adults with a disease or condition
      accompanied by reduced bone mass or bone loss; all persons in the appointment of drug
      therapy, iatrogenic in relation to loss of bone mass; all patients receiving anti-osteopathic
      treatment to monitor its effectiveness; all persons who are not yet receiving treatment, but
      who may need it in case of bone loss.), Dual-Energy X-Ray Absorptiometry (DEXA) of skeleton
      mineral bone density will be done. Treatment with vitamin D3 for stabilization of its level
      (>30 ng/ml, or >75 nmol/l) will be provided with Aquadetrim (cholecalciferol) 15000
      International Units (IU), Medana Pharma S.A., Poland, Registration number P N014088/01 from
      21st June 2017; first 2 months taking orally 2-5 drops with a spoon of water depending on the
      severity of diseases, after 2 months and reaching the reference level of vitamin D its dose
      will be 1 drop per a day whole period of monitoring). The dental implantation was and will be
      performed with the further control of bone density and peri-implant tissues in 3 months after
      operation at the beginning of treatment by endocrinologist without waiting of reference level
      of vitamin D. In case of low bone density of jaws (type 3 or 4) the additional bone plasty
      was or will be performed. We will assess the stability of dental implant on the stages of
      prosthetic rehabilitation according to the force of osteointegration during the inserting of
      the healing abutment (in Newtons on square centimeter), and each 1 year after treatment in
      the condition of periodical monitoring of patients with the endocrinologist (after the
      beginning of treatment after 2 months, then 1 time per 6 months)

      Traditional 2-stage dental implantation according to surgical protocols of dental implant
      systems (Straumann (Institut Straumann AG, Switzerland, registration in Russia 03/10/2017 No
      FSZ 2010/06855), Astra Tech (Dentsply Implant Manufacturing GmbH, Germany, registration in
      Russia 27/09/2018 No FSZ 2008/02570), Xive (FRIADENT GmbH, Germany, registration in Russia
      09/09/2008 No FSZ 2008/02568), Alpha Bio (Alpha Bio Tec Ltd., Israel, registration in Russia
      26/04/2017 No FSZ 2009/05582), will be performed for different types of bone tissue
    

Intervention name(s): Dental implantation
Intervention type(s): Procedure
Intervention description(s): 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
Other intervention name(s): Bone plasty
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Interventional retrospective prospective randomized clinical trial (RCT) in parallel groups.
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: tooth loss; vitamin D3 deficiency; dental implantation