An interventional study of Dental implantation in Tooth Loss, Vitamin D3 Deficiency and Osteomalacia, sponsored by I.M. Sechenov First Moscow State Medical University. Completed at 2 sites in Russian Federation. Open to participants aged 25 Years to 50 Years. Per ClinicalTrials.gov, last updated 2022-08-12.
Sponsored by I.M. Sechenov First Moscow State Medical University · Not applicable, Interventional, and Treatment
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.
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
165 studies on the registry are indexed under Tooth Loss; 44 are open to participants now.
This study's enrollment of 384 is above the median of 30 across 120 interventional studies indexed under Tooth Loss.
Browse Tooth Loss studies →I.M. Sechenov First Moscow State Medical University is the lead sponsor of 137 studies on the registry; 28 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with loss of teeth and mineral metabolism disorders due to vitamin D3 imbalance (n=192) who will undergo dental implant placement after stabilization of vitamin D3 levels
Procedure: Dental implantation
Patients with the loss of teeth and mineral metabolism disorders due to vitamin D3 imbalance (n=192) who undergo the dental implantation during treatment by an endocrinologist
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
Also known as: Bone plasty
Primary Stability of dental implant
It can be assessed with the volume of torque during dental implant insertion with the physio-dispenser according to its program
Time frame: Day 0
Secondary Stability of dental implants after surgery
During the inserting of healing abutment the stability of dental implant will and was measured with the help of device Penguin RFA (Integration Diagnostics, Sweden, Registration 29th of December 2017 RZN No 2017/6664) (Quotient of stability depends on the scale from 1 to 99 ) based on resonance frequency analysis through the handpiece of device MulTipeg. The use of device will not and did not lead to the loss or mobility of dental implants.
Time frame: Days 60-90
Colour of peri-implant tissues according to clinical examination after surgery
The condition of peri-implant tissues will be assessed according to their colour (points 0-1, where 0 - normal colour, 1- redness).
Time frame: Days 3-7
Oedema of peri-implant tissues according to clinical examination after surgery
The condition of peri-implant tissues will be assessed according to oedema volume (points 0-2, where 0- absence of oedema, 1- average oedema, 2 -intensive oedema in comparison to adjunct tissues condition)
Time frame: Days 3-7
Colour of peri-implant tissues according to clinical examination after surgery (for additional operations such bone plasty)
The condition of peri-implant tissues will be assessed according to their colour (points 0-1, where 0 - normal colour, 1- redness).
Time frame: Days 10-14
Oedema of peri-implant tissues according to clinical examination after surgery (for additional operations such bone plasty)
The condition of peri-implant tissues will be assessed according to oedema volume (points 0-2, where 0- absence of oedema, 1- average oedema, 2 -intensive oedema in comparison to adjunct tissues condition)
Time frame: Days 10-14
Colour of peri-implant tissues
The condition of peri-implant tissues will be assessed according to their colour (points 0-1, where 0 - normal colour, 1- redness).
Time frame: Days 365-366
Peri-implant pockets presence according to clinical examination
The condition of peri-implant tissues will be assessed according to presence of peri-implant pockets during probing (mm).
Time frame: Days 365-366
Condition of peri-implant tissues according to X-ray or cone-bean computed tomography
The condition of peri-implant tissues will be assessed according to presence of peri-implant pockets during radiological investigation (mm).
Time frame: Days 365-366
Plan to share: No — No, according to the rules (SOPs) of the Local Ethics Committee
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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