Vitamin D DeficiencyNCT06412705
Vit D and Post-extractive Bone Turnover
A study testing Tooth extraction, guided bone regeneration and dental implant in people with Vitamin D Deficiency and Alveolar Bone Loss, run by Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo at 1 site in Italy.
Trial summary
The aims of the study was to correlate the extent of the dimensional alveolar bone changes after tooth extraction and contextual guided bone regeneration with serum vit D levels in 14 patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency, Alveolar Bone Loss, Alveolar Bone Resorption
- What is being tested?
- Tooth extraction, guided bone regeneration and dental implant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteItaly
- Study dates
- 2 Oct 2023to 30 Apr 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female adult (≥ 18 years old)
- Patients willing to participate and to attend the planned follow-up visits
Who cannot join
- Absence of Type 1-Medical conditions requiring prolonged use of steroids and/or medications that can interfere with bone metabolism
- History of leukocyte dysfunction and deficiencies
- History of neoplastic disease requiring the use of radiation or chemotherapy
- History of renal failure
- Metabolic disorders such as osteoporosis and correlated vit D or antiresorptive medications assumption
- Physical handicaps that would interfere with the ability to perform adequate oral hygiene
Show all 15Show fewer
- History of uncontrolled endocrine disorders
- Alcoholism or any drug abuse
- History of immunodeficiency syndromes
- Smoker of 10 cig per day, cigar equivalents or tobacco chewers
- Conditions or circumstances which in the opinion of the investigator would prevent completion of study participation or interfere with the analysis of the study results, such as history of non-compliance or unreliability
- Mucosa disease such as erosive lichen planus
- Residual post-extraction site with intact bone walls
- History of local irradiation therapy
- Persistent intraoral infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Vit D on Post-extraction Site Bone Remodeling and Regeneration After 4 Months: A Prospective Clinical Trial
The aims of the study was to correlate the extent of the dimensional alveolar bone changes after tooth extraction and contextual guided bone regeneration with serum vit D levels in 14 patients. Moreover, at 4 months, a small bone sample was collected in order to correlate histological and immunohistochemical parameters of bone with vit D serum levels.
Read the detailed description
The study included 14 patients requiring tooth extraction and subsequent post-extraction bone regeneration with heterologous graft material of porcine origin. Four months after extraction, dental implants were placed, and insertion torque values (ITV) and implant stability quotients (ISQ) were recorded. During implant placement, a small bone sample was collected for histological analysis. The aim of the study was to analyze the correlation between serum vitamin D levels and post-extraction bone volume contraction, collagen type I (Col1A1), osteocalcin, osteopontin, runt-related transcription factor 2 (Runx2), ITV, ISQ, Newly Formed Bone Tissue (NFBT).
- Being tested
- Tooth extraction, guided bone regeneration and dental implant
- Keywords
- Dental Implants, Alveolar Bone Loss, Alveolar Process
- Medical subject headings
- Vitamin D Deficiency, Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tooth extraction, guided bone regeneration and dental implantProcedure or surgery
The arm received tooth extraction and contextual guided bone regeneration. After 4 months, a dental implant was inserted.
| Study group | Role | What they receive |
|---|---|---|
| Tooth extraction and bone regeneration | Experimental | The present arm received tooth extraction and guided bone regeneration (performed with xenograft porcine material and collagen barrier membrane). After 4 months, a dental implant was inserted. Receives: Procedure: Tooth extraction, guided bone regeneration and dental implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dimensional alveolar bone changes
Volumetrical changes of alveolar bone after tooth extraction measured by superimposition of two intraoral scans. The first was registered before the extraction of the tooth. The second was registered after 4 months (before inserting implant). The parameter used to measure the dimensional alveolar bone change is called "Integrated Distance" and it is expressed in mm3.
Measured: From extraction to implant insertion (4 months)
Evaluation of new formed bone tissue
Evaluation of new formed bone tissue performed by histomorphometric methods.
Measured: Time of implant insertion: 4 months after extraction
Evaluation of Total Calcified Tissue (TCT)
Evaluation of Total Calcified Tissue composed by the residual bone substitute utilized for regeneration plus the NFBT. The evaluation was performed by histomorphometrics methods.
Measured: Time of implant insertion: 4 months after extraction
Expression of Collagen A1
quantitative analysis of immunohistochemistry performed using deconvolution tool for ImageJ.
Measured: Time of implant insertion: 4 months after extraction
Expression of Osteocalcin
quantitative analysis of immunohistochemistry performed using deconvolution tool for ImageJ.
Measured: Time of implant insertion: 4 months after extraction
Expression of Osteopontin
quantitative analysis of immunohistochemistry performed using deconvolution tool for ImageJ.
Measured: Time of implant insertion: 4 months after extraction
Expression of Runx-2
quantitative analysis of immunohistochemistry performed using deconvolution tool for ImageJ.
Measured: Time of implant insertion: 4 months after extraction
Evaluation of Implant Stability Quotient (ISQ)
Evaluation of Implant Stability Quotient after the implant insertion. The measurement was performed with "Osstell" system (W\&H)
Measured: Time of implant insertion: 4 months after extraction
Evaluation of Implant Torque Value (ITV)
Evaluation of Implant Torque Value at the implant insertion performed with the surgery implant device.
Measured: Time of implant insertion: 4 months after extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start2 Oct 2023
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luigi Canullo, Principal investigator, Studi Odontoiatrici Luigi Canullo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06412705
- Sponsor's protocol ID
- VITD-01
- Status last verified
- May 2024
- First submitted
- 5 May 2024
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vit D on Post-extraction Site Bone Remodeling and Regeneration After 4 Months: A Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT06412705
- Acronym / sponsor ID
- VITD-01
- Keywords
- Dental Implants, Alveolar Bone Loss, Alveolar Process
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Studio Odontoiatrico Associato Dr. P. Cicchese e L. CanulloUniversity, hospital or other
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 14 May 2024 (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.
The aims of the study was to correlate the extent of the dimensional alveolar bone changes after tooth extraction and contextual guided bone regeneration with serum vit D levels in 14 patients. Moreover, at 4 months, a small bone sample was collected in order to correlate histological and immunohistochemical parameters of bone with vit D serum levels.
Detailed description
The study included 14 patients requiring tooth extraction and subsequent post-extraction bone regeneration with heterologous graft material of porcine origin. Four months after extraction, dental implants were placed, and insertion torque values (ITV) and implant stability quotients (ISQ) were recorded. During implant placement, a small bone sample was collected for histological analysis. The aim of the study was to analyze the correlation between serum vitamin D levels and post-extraction bone volume contraction, collagen type I (Col1A1), osteocalcin, osteopontin, runt-related transcription factor 2 (Runx2), ITV, ISQ, Newly Formed Bone Tissue (NFBT).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tooth extraction and bone regeneration | Experimental | Procedure: Tooth extraction, guided bone regeneration and dental implantThe present arm received tooth extraction and guided bone regeneration (performed with xenograft porcine material and collagen barrier membrane). After 4 months, a dental implant was inserted. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female adult (≥ 18 years old)
- Patients willing to participate and to attend the planned follow-up visits
Key exclusion criteria (15 listed)
- Absence of Type 1-Medical conditions requiring prolonged use of steroids and/or medications that can interfere with bone metabolism
- History of leukocyte dysfunction and deficiencies
- History of neoplastic disease requiring the use of radiation or chemotherapy
- History of renal failure
- Metabolic disorders such as osteoporosis and correlated vit D or antiresorptive medications assumption
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 |
|---|---|---|
| Tooth extraction, guided bone regeneration and dental implantThe arm received tooth extraction and contextual guided bone regeneration. After 4 months, a dental implant was inserted. | Procedure or surgery | Tooth extraction and bone regeneration |
Primary outcome
Dimensional alveolar bone changes
Time frame: From extraction to implant insertion (4 months)
Volumetrical changes of alveolar bone after tooth extraction measured by superimposition of two intraoral scans. The first was registered before the extraction of the tooth. The second was registered after 4 months (before inserting implant). The parameter used to measure the dimensional alveolar bone change is called "Integrated Distance" and it is expressed in mm3.
Evaluation of new formed bone tissue
Time frame: Time of implant insertion: 4 months after extraction
Evaluation of new formed bone tissue performed by histomorphometric methods.
Evaluation of Total Calcified Tissue (TCT)
Time frame: Time of implant insertion: 4 months after extraction
Evaluation of Total Calcified Tissue composed by the residual bone substitute utilized for regeneration plus the NFBT. The evaluation was performed by histomorphometrics methods.
Expression of Collagen A1
Time frame: Time of implant insertion: 4 months after extraction
quantitative analysis of immunohistochemistry performed using deconvolution tool for ImageJ.
Expression of Osteocalcin
Time frame: Time of implant insertion: 4 months after extraction
quantitative analysis of immunohistochemistry performed using deconvolution tool for ImageJ.
Expression of Osteopontin
Time frame: Time of implant insertion: 4 months after extraction
quantitative analysis of immunohistochemistry performed using deconvolution tool for ImageJ.
Expression of Runx-2
Time frame: Time of implant insertion: 4 months after extraction
quantitative analysis of immunohistochemistry performed using deconvolution tool for ImageJ.
Evaluation of Implant Stability Quotient (ISQ)
Time frame: Time of implant insertion: 4 months after extraction
Evaluation of Implant Stability Quotient after the implant insertion. The measurement was performed with "Osstell" system (W\&H)
Evaluation of Implant Torque Value (ITV)
Time frame: Time of implant insertion: 4 months after extraction
Evaluation of Implant Torque Value at the implant insertion performed with the surgery implant device.
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 14 May 2024.
- Individual participant dataSharing planned: No
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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.
Luigi Canullo principal investigator
Studi Odontoiatrici Luigi Canullo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tooth extraction, guided bone regeneration and dental implant in people with Vitamin D Deficiency and Alveolar Bone Loss, run by Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo at 1 site in Italy.
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 2 inclusion and 15 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 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
Dimensional alveolar bone changes (time frame: From extraction to implant insertion (4 months)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2024.