Dental Implants Rehabilitation in Patients With Vitamin D3 Imbalance
Prosthetics Dental Implant-based Rehabilitation in Patients With Loss of Teeth and Mineral Metabolism Disorders Due to Vitamin D3 Imbalance
1 other identifier
interventional
384
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2021
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 6, 2021
CompletedStudy Start
First participant enrolled
April 10, 2021
CompletedFirst Posted
Study publicly available on registry
April 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 10, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2022
CompletedAugust 12, 2022
August 1, 2022
1 year
April 6, 2021
August 10, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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.
Days 60-90
Secondary Outcomes (7)
Colour of peri-implant tissues according to clinical examination after surgery
Days 3-7
Oedema of peri-implant tissues according to clinical examination after surgery
Days 3-7
Colour of peri-implant tissues according to clinical examination after surgery (for additional operations such bone plasty)
Days 10-14
Oedema of peri-implant tissues according to clinical examination after surgery (for additional operations such bone plasty)
Days 10-14
Colour of peri-implant tissues
Days 365-366
- +2 more secondary outcomes
Study Arms (2)
Group after vitamin D3 level stabilization
ACTIVE COMPARATORPatients 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 COMPARATORPatients 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
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Refusal of the patient from further participation in the study
- Non-compliance by the patient with postoperative recommendations.
- Residence address change
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
prof. Tarasenko Svetlana
Moscow, 119991, Russia
Vladimir Grachev
Moscow, 127015, Russia
Related Publications (1)
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.
PMID: 33257353RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ekaterina Diachkova, PhD
I.M.Sechenov First Moscow State Medical University (Sechenov University)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Masking Details
- Surgeons will be blinded to the endocrinologic status of patients who underwent or will undergo the dental implantation
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 6, 2021
First Posted
April 12, 2021
Study Start
April 10, 2021
Primary Completion
April 10, 2022
Study Completion
August 1, 2022
Last Updated
August 12, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share
No, according to the rules (SOPs) of the Local Ethics Committee