Tooth LossNCT04841213
Dental Implants Rehabilitation in Patients With Vitamin D3 Imbalance
A study testing Dental implantation in people with Tooth Loss and Vitamin D3 Deficiency, run by I.M. Sechenov First Moscow State Medical University at 2 sites in Russia.
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). Read more about this study
- Who is it for?
- Ages 25 to 50 years
- Conditions the study is for
- Tooth Loss, Vitamin D3 Deficiency, Osteomalacia
- What is being tested?
- Dental implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- 2 sitesRussia
- Study dates
- 10 Apr 2021to 1 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Signing of written informed consent of the patient to participate in a study
- Age from 25 to 50 years old
- Established diagnosis: tooth loss (K08.1- ICD 10), vitamin D3 imbalance.
- Patients who are medically stable
Who cannot join
- Refusal of the patient from further participation in the study
- Pregnancy diagnosed after the inclusion into the trial
- Non-compliance by the patient with postoperative recommendations.
- Residence address change
Trial locations and contacts
2 sites in 1 country.
Russia2 sites
prof. Tarasenko Svetlana
Moscow, 119991
Vladimir Grachev
Moscow, 127015
About this study
Official title: Prosthetics Dental Implant-based Rehabilitation in Patients With Loss of Teeth and Mineral Metabolism Disorders Due to Vitamin D3 Imbalance
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).
Read more
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.
Read the 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
- Conditions
- Tooth Loss, Vitamin D3 Deficiency, Osteomalacia
- Being tested
- Dental implantation
- Keywords
- tooth loss, vitamin D3 deficiency, dental implantation
- Medical subject headings
- Tooth Loss, Osteomalacia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental implantationProcedure or surgery
Also called Bone plasty
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
| Study group | Role | What they receive |
|---|---|---|
| Group after vitamin D3 level stabilization | Active comparator | 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 Receives: Procedure: Dental implantation |
| Group before vitamin D3 level stabilization | Active comparator | 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 Receives: Procedure: Dental implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Days 60-90
Secondary outcomes (7)
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).
Measured: 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)
Measured: 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).
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Days 365-366
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start10 Apr 2021
- Primary completion10 Apr 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tooth LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional retrospective prospective randomized clinical trial (RCT) in parallel groups.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 384 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ekaterina Diachkova, PhD, Principal investigator, I.M.Sechenov First Moscow State Medical University (Sechenov University)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04841213
- Sponsor's protocol ID
- 13081986
- Status last verified
- Aug 2022
- First submitted
- 6 Apr 2021
- Last updated
- 12 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No, according to the rules (SOPs) of the Local Ethics Committee
Publications
Diachkova E, Abramova EV, Blagushina NA, Tarasenko S. Surgical treatment with dental implants in a patient with secondary loss of teeth and osteoporosis caused by an imbalance of vitamin D. BMJ Case Rep. 2020 Nov 30;13(11):e235585. doi: 10.1136/bcr-2020-235585.
PubMed 33257353
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prosthetics Dental Implant-based Rehabilitation in Patients With Loss of Teeth and Mineral Metabolism Disorders Due to Vitamin D3 Imbalance
- ClinicalTrials.gov ID
- NCT04841213
- Acronym / sponsor ID
- 13081986
- Conditions
- Tooth Loss, Vitamin D3 Deficiency, Osteomalacia
- Keywords
- tooth loss, vitamin D3 deficiency, dental implantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 384 participants (actual)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 10 Apr 2021 (actual)
- Primary completion
- 10 Apr 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 12 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Interventional retrospective prospective randomized clinical trial (RCT) in parallel groups.
| Arm | Type | Receives |
|---|---|---|
| Group after vitamin D3 level stabilization | Active comparator | Procedure: Dental implantationPatients 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 |
| Group before vitamin D3 level stabilization | Active comparator | Procedure: Dental implantationPatients 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 |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Signing of written informed consent of the patient to participate in a study
- Age from 25 to 50 years old
- Established diagnosis: tooth loss (K08.1- ICD 10), vitamin D3 imbalance.
- Patients who are medically stable
Key exclusion criteria (4 listed)
- Refusal of the patient from further participation in the study
- Pregnancy diagnosed after the inclusion into the trial
- Non-compliance by the patient with postoperative recommendations.
- Residence address change
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dental implantationAlso: Bone plastyTraditional 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 | Procedure or surgery | Group after vitamin D3 level stabilization, Group before vitamin D3 level stabilization |
Primary outcome
Primary Stability of dental implant
Time frame: Day 0
It can be assessed with the volume of torque during dental implant insertion with the physio-dispenser according to its program
Secondary Stability of dental implants after surgery
Time frame: Days 60-90
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.
7 secondary outcomes
Colour of peri-implant tissues according to clinical examination after surgery
Time frame: Days 3-7
Oedema of peri-implant tissues according to clinical examination after surgery
Time frame: Days 3-7
Colour of peri-implant tissues according to clinical examination after surgery (for additional operations such bone plasty)
Time frame: Days 10-14
Oedema of peri-implant tissues according to clinical examination after surgery (for additional operations such bone plasty)
Time frame: Days 10-14
Colour of peri-implant tissues
Time frame: Days 365-366
Peri-implant pockets presence according to clinical examination
Time frame: Days 365-366
Condition of peri-implant tissues according to X-ray or cone-bean computed tomography
Time frame: Days 365-366
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2022.
- Results publication: PubMed 33257353Diachkova E, Abramova EV, Blagushina NA, Tarasenko S. Surgical treatment with dental implants in a patient with secondary loss of teeth and osteoporosis caused by an imbalance of vitamin D. BMJ Case Rep. 2020 Nov 30;13(11):e235585. doi: 10.1136/bcr-2020-235585.
- Individual participant dataSharing planned: No. No, according to the rules (SOPs) of the Local Ethics Committee
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ekaterina Diachkova, PhD principal investigator
I.M.Sechenov First Moscow State Medical University (Sechenov University)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental implantation in people with Tooth Loss and Vitamin D3 Deficiency, run by I.M. Sechenov First Moscow State Medical University at 2 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Stability of dental implant (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04841213, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2022.