Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04841213 |
| Other study ID # |
13081986 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 10, 2021 |
| Est. completion date |
August 1, 2022 |
Study information
| Verified date |
August 2022 |
| Source |
I.M. Sechenov First Moscow State Medical University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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
