Vitamin D DeficiencyVit D and boneNCT07200011
Effect of Vitamin D on the Clinical and Radiographic of Unsplinted Mandibular Implant Overdentures
An observational study of Vitamin D Deficiency and Implant Assesment, run by Mansoura University at 1 site in Egypt.
Trial summary
This study investigates the effect of vitamin D on bone loss around mandibular implant overdentures. Bone levels around implants will be measured to understand how vitamin Daffect the health of implant-supported dentures. This information may help improve dental treatment outcomes Read more about this study
- Who is it for?
- Ages 40 to 60 years, men only
- Conditions the study is for
- Vitamin D Deficiency, Implant Assesment, Radiography
- What is being tested?
- Observational: Serum Vitamin D Levels
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2025to 20 Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 40 to 60 years
- Men only
- No healthy volunteers
- Adult
Study population: This retrospective study includes adult patients aged 40 to 60 years who have been rehabilitated with unsplinted three-implant mandibular overdentures retained by locator attachments. Only patients with complete clinical records, including serum vitamin D levels and adequate baseline and follow-up periapical radiographs are included. Patients with systemic diseases affecting bone metabolism, history of smoking or alcohol abuse, or medications known to influence bone healing are excluded. The study population are stratified based on serum vitamin D levels into two groups: deficient (<20 ng/mL) and sufficient (≥30 ng/mL)
Who may be able to join
- Age between 40 and 60 years.
- Patients rehabilitated with unsplinted three-implant mandibular overdentures retained by LOCATOR attachments .
- Availability of recent serum vitamin D records at determined time intervals.
- Good general health without uncontrolled systemic diseases.
Who cannot join
- Missing or incomplete patient records.
- Patients on medications known to affect bone metabolism.
- History of smoking or alcohol abuse.
- Patients with borderline serum vitamin D values (21-29 ng/mL) to avoid classification bias.
- Presence of active oral infections or untreated periodontal disease.
- Previous implant failure in the mandible.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Mansoura University
Al Mansurah, Dakahlia Governorate, 35516
About this study
Official title: Effect of Serum Vitamin D Levels on the Clinical and Radiographic Outcomes of Unsplinted Mandibular Implant Overdentures
This study investigates the effect of vitamin D on bone loss around mandibular implant overdentures. Bone levels around implants will be measured to understand how vitamin Daffect the health of implant-supported dentures. This information may help improve dental treatment outcomes
Read the detailed description
Tooth loss affects patient's quality of life. The use of mandibular implant overdentures is an accepted treatment option that improves prosthesis retention, stability, and masticatory efficiency compared to conventional complete dentures.
Vitamin D plays a critical role in bone metabolism and osseointegration of dental implants. Deficiency may impair bone healing and accelerate peri-implant bone loss.
The purpose of this retrospective study is to clinically and radiographically evaluate the effect of serum vitamin D levels on peri-implant tissues in patients rehabilitated with unsplinted mandibular implant overdentures.
Patient records are screened for serum vitamin D levels, radiographs at baseline of loading and follow-up intervals ( 6 \& 12 months after loading )and clinical notes.
Patients categorize into two groups based on their recorded serum vitamin D levels: group A - deficient vitamin D : < 20 ng/mL and group B - sufficient vitamin D: ≥ 30 ng/mL.
All participants rehabilitated with unsplinted, three-implant mandibular overdentures assisted by LOCATOR attachments. Minor variations in implant dimensions and positioning are accepted, provided the implants were placed in the midline and posterior regions.
All implants should be placed using a flapless surgical protocol with delayed loading protocol.
The clinical evaluation included peri-implant soft tissue parameters in patients records such as plaque index, gingival index, bleeding on probing, and probing pocket depth to monitor peri-implant health. Also, prosthesis-related factors, including stability, retention, and occlusion, were also evaluated and recorded. In addition, implant status were evaluated and recorded through mobility testing and the presence of peri-implant infection or suppuration .
Marginal bone loss (vertically and horizontally) is measured on the mesial and distal sides of each dental implant on the periapical radiographs by using the software program (Scanora light version 3.2.6; SOREDEX) calibration.
Vertical bone height (AB) is considered as the distance between the implant shoulder and the bone-to-implant contact parallel to the implant long axis. Radiographic vertical bone loss (VBL) is estimated by subtracting radiographic AB at T6 and T12 from AB at T0.
Actual VBL is calculated by multiplying the actual implant length by the radiographic VBL and dividing the result by the radiographic length of the implant to account for magnification error.
To measure the horizontal alveolar bone loss (HBL), the distance between the peri- implant bone level (C point of crest) [which is the crossing Point of the tangent to the horizontal bone crest (CD line) and the tangent to the crater-shaped defect (CB line)] and the implant at the (E Point) right angle is measured and referred to the horizontal bone level. To measure horizontal bone loss (HBL), the horizontal bone level at T6 and T12 is subtracted from T0.
Actual HBL is calculated by multiplying the actual implant diameter by the radiographic HBL and dividing the result by the radiographic diameter of the implant in order to account for magnification error.
Data are analyzed using statistical software (SPSS, version 22.0; SPSS Inc., Chicago, IL). The Shapiro-Wilk test is used to assess the normality of the bone loss data. Descriptive statistics are expressed as mean ± standard deviation. Repeated measures analysis of variance (ANOVA) is used to evaluate changes in bone loss over time, followed by the Tukey Post hoc test for pairwise comparisons between time intervals. Intergroup differences are assessed using the independent samples t test. A P value <.05 is considered statistically significant at a 95% confidence level.
- Being tested
- Observational: Serum Vitamin D Levels
- Keywords
- Vitamin D, marginal bone loss, mandibular implant overdenture, un-splinted implants, LOCATOR attachments,periapical radiographs.
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational: Serum Vitamin D LevelsOther
Participants' serum vitamin D levels will be measured from existing laboratory records, and radiographic images of mandibular implant overdentures will be analyzed to assess marginal bone loss. No active treatment or experimental intervention will be administered
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D-deficient (<20 ng/mL) | Participants with serum vitamin D <20 ng/mL Receives: Other: Observational: Serum Vitamin D Levels | |
| Vitamin D-sufficient (≥30 ng/mL) | Participants with serum vitamin D ≥30 ng/mL Receives: Other: Observational: Serum Vitamin D Levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between serum vitamin D levels and radiographic marginal bone loss around unsplinted mandibular implant overdentures
Marginal bone loss vertically (VBL) and horizontally (HBL) around each unsplinted mandibular dental implant are measured on standardized digital periapical radiographs using Scanora Light software (mm).
Serum vitamin D levels (ng/mL) are obtained from patient records. The correlation between serum vitamin D concentration and marginal bone loss will be analyzed.
Measured: Baseline (prosthetic loading), 6 months, 12 months after loading (T0,T6,T12)
Secondary outcomes (4)
Clinical & peri-implant outcomes of unsplinted mandibular implant overdentures Peri-implant soft tissue health: plaque index , gingival index, bleeding on probing
Clinical and peri-implant parameters are assessed from patient avilable records and clinical examinations. Peri-implant soft tissue health were evaluated in patients records by using plaque index , gingival index , bleeding on probing.
Unit of Measure / Measurement Tool:
Plaque Index % (PI%) (Patient chart records) Gingival Index % (GI %) (Patient chart records) Bleeding on Probing % (BOP% ) (Patient chart records)
Measured: Baseline (prosthetic loading), 6 months, 12 months after loading T0, T6,T12
Clinical and peri-implant parameters are assessed from patient avilable records and clinical examinations: probing pocket depth
Clinical and peri-implant parameters are assessed from patient avilable records and clinical examinations. Peri-implant probing pocket depth was evaluated in patients records peridontal probe.
Unit of Measure / Measurement Tool:
Probing Pocket Depth (mm) (Patient chart records)
Measured: Baseline (prosthetic loading), 6 months, 12 months after loading T0, T6,T12
Implant status including mobility and presence of peri-implant infection or suppuration were also evaluated and recorded in all patients data.
Mobility Unit: Qualitative (Present / Absent) Clinical significance: presence of mobility indicates loss of osseointegration and implant failure.
Peri-implant infection / suppuration Unit: Qualitative (Present / Absent) Recorded when signs of infection (e.g., purulent exudate, swelling, erythema) were detected upon probing or palpation.
Measured: Baseline (prosthetic loading), 6 months, 12 months after loading T0, T6,T12
Prosthesis-related factors, including stability, retention, and occlusion, were assessed clinically.
Stability Unit: Qualitative (Good / Poor) Refers to absence of rocking or movement of the overdenture under functional load.
Retention Unit: Qualitative (Adequate / Inadequate) Determined by resistance of the overdenture to vertical dislodgement when gentle pulling is applied.
Occlusion Unit: Qualitative (Acceptable / Unacceptable) Evaluated based on even bilateral contacts, absence of premature contacts, and proper centric occlusion.
Measured: Baseline (prosthetic loading), 6 months, 12 months after loading T0, T6,T12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start1 Sep 2025
- Primary completion15 Oct 2025 (estimated)
- Study completion20 Oct 2025 (estimated)
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.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rahma elhussany mohammed, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07200011
- Sponsor's protocol ID
- R.25.07.10
- Acronym
- Vit D and bone
- Status last verified
- Sep 2025
- First submitted
- 3 Sep 2025
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study is a retrospective observational study using existing patient records. Individual participant data will not be shared to protect patient confidentiality and privacy, and due to restrictions in accessing historical medical records
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Serum Vitamin D Levels on the Clinical and Radiographic Outcomes of Unsplinted Mandibular Implant Overdentures
- ClinicalTrials.gov ID
- NCT07200011
- Acronym / sponsor ID
- Vit D and bone / R.25.07.10
- Keywords
- Vitamin D, marginal bone loss, mandibular implant overdenture, un-splinted implants, LOCATOR attachments,periapical radiographs.
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 15 Oct 2025 (estimated)
- Study completion
- 20 Oct 2025 (estimated)
- First posted
- 30 Sep 2025 (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.
This study investigates the effect of vitamin D on bone loss around mandibular implant overdentures. Bone levels around implants will be measured to understand how vitamin Daffect the health of implant-supported dentures. This information may help improve dental treatment outcomes
Detailed description
Tooth loss affects patient's quality of life. The use of mandibular implant overdentures is an accepted treatment option that improves prosthesis retention, stability, and masticatory efficiency compared to conventional complete dentures.
Vitamin D plays a critical role in bone metabolism and osseointegration of dental implants. Deficiency may impair bone healing and accelerate peri-implant bone loss.
The purpose of this retrospective study is to clinically and radiographically evaluate the effect of serum vitamin D levels on peri-implant tissues in patients rehabilitated with unsplinted mandibular implant overdentures.
Patient records are screened for serum vitamin D levels, radiographs at baseline of loading and follow-up intervals ( 6 \& 12 months after loading )and clinical notes.
Patients categorize into two groups based on their recorded serum vitamin D levels: group A - deficient vitamin D : < 20 ng/mL and group B - sufficient vitamin D: ≥ 30 ng/mL.
All participants rehabilitated with unsplinted, three-implant mandibular overdentures assisted by LOCATOR attachments. Minor variations in implant dimensions and positioning are accepted, provided the implants were placed in the midline and posterior regions.
All implants should be placed using a flapless surgical protocol with delayed loading protocol.
The clinical evaluation included peri-implant soft tissue parameters in patients records such as plaque index, gingival index, bleeding on probing, and probing pocket depth to monitor peri-implant health. Also, prosthesis-related factors, including stability, retention, and occlusion, were also evaluated and recorded. In addition, implant status were evaluated and recorded through mobility testing and the presence of peri-implant infection or suppuration .
Marginal bone loss (vertically and horizontally) is measured on the mesial and distal sides of each dental implant on the periapical radiographs by using the software program (Scanora light version 3.2.6; SOREDEX) calibration.
Vertical bone height (AB) is considered as the distance between the implant shoulder and the bone-to-implant contact parallel to the implant long axis. Radiographic vertical bone loss (VBL) is estimated by subtracting radiographic AB at T6 and T12 from AB at T0.
Actual VBL is calculated by multiplying the actual implant length by the radiographic VBL and dividing the result by the radiographic length of the implant to account for magnification error.
To measure the horizontal alveolar bone loss (HBL), the distance between the peri- implant bone level (C point of crest) [which is the crossing Point of the tangent to the horizontal bone crest (CD line) and the tangent to the crater-shaped defect (CB line)] and the implant at the (E Point) right angle is measured and referred to the horizontal bone level. To measure horizontal bone loss (HBL), the horizontal bone level at T6 and T12 is subtracted from T0.
Actual HBL is calculated by multiplying the actual implant diameter by the radiographic HBL and dividing the result by the radiographic diameter of the implant in order to account for magnification error.
Data are analyzed using statistical software (SPSS, version 22.0; SPSS Inc., Chicago, IL). The Shapiro-Wilk test is used to assess the normality of the bone loss data. Descriptive statistics are expressed as mean ± standard deviation. Repeated measures analysis of variance (ANOVA) is used to evaluate changes in bone loss over time, followed by the Tukey Post hoc test for pairwise comparisons between time intervals. Intergroup differences are assessed using the independent samples t test. A P value <.05 is considered statistically significant at a 95% confidence level.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D-deficient (<20 ng/mL) | – | Other: Observational: Serum Vitamin D LevelsParticipants with serum vitamin D <20 ng/mL |
| Vitamin D-sufficient (≥30 ng/mL) | – | Other: Observational: Serum Vitamin D LevelsParticipants with serum vitamin D ≥30 ng/mL |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This retrospective study includes adult patients aged 40 to 60 years who have been rehabilitated with unsplinted three-implant mandibular overdentures retained by locator attachments. Only patients with complete clinical records, including serum vitamin D levels and adequate baseline and follow-up periapical radiographs are included. Patients with systemic diseases affecting bone metabolism, history of smoking or alcohol abuse, or medications known to influence bone healing are excluded. The study population are stratified based on serum vitamin D levels into two groups: deficient (<20 ng/mL) and sufficient (≥30 ng/mL)
Key inclusion criteria (4 listed)
- Age between 40 and 60 years.
- Patients rehabilitated with unsplinted three-implant mandibular overdentures retained by LOCATOR attachments .
- Availability of recent serum vitamin D records at determined time intervals.
- Good general health without uncontrolled systemic diseases.
Key exclusion criteria (6 listed)
- Missing or incomplete patient records.
- Patients on medications known to affect bone metabolism.
- History of smoking or alcohol abuse.
- Patients with borderline serum vitamin D values (21-29 ng/mL) to avoid classification bias.
- Presence of active oral infections or untreated periodontal disease.
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 |
|---|---|---|
| Observational: Serum Vitamin D LevelsParticipants' serum vitamin D levels will be measured from existing laboratory records, and radiographic images of mandibular implant overdentures will be analyzed to assess marginal bone loss. No active treatment or experimental intervention will be administered | Other | Vitamin D-deficient (<20 ng/mL), Vitamin D-sufficient (≥30 ng/mL) |
Primary outcome
Correlation between serum vitamin D levels and radiographic marginal bone loss around unsplinted mandibular implant overdentures
Time frame: Baseline (prosthetic loading), 6 months, 12 months after loading (T0,T6,T12)
Marginal bone loss vertically (VBL) and horizontally (HBL) around each unsplinted mandibular dental implant are measured on standardized digital periapical radiographs using Scanora Light software (mm). Serum vitamin D levels (ng/mL) are obtained from patient records. The correlation between serum vitamin D concentration and marginal bone loss will be analyzed.
4 secondary outcomes
Clinical & peri-implant outcomes of unsplinted mandibular implant overdentures Peri-implant soft tissue health: plaque index , gingival index, bleeding on probing
Time frame: Baseline (prosthetic loading), 6 months, 12 months after loading T0, T6,T12
Clinical and peri-implant parameters are assessed from patient avilable records and clinical examinations: probing pocket depth
Time frame: Baseline (prosthetic loading), 6 months, 12 months after loading T0, T6,T12
Implant status including mobility and presence of peri-implant infection or suppuration were also evaluated and recorded in all patients data.
Time frame: Baseline (prosthetic loading), 6 months, 12 months after loading T0, T6,T12
Prosthesis-related factors, including stability, retention, and occlusion, were assessed clinically.
Time frame: Baseline (prosthetic loading), 6 months, 12 months after loading T0, T6,T12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Direct procedure for connecting a mandibular implant-retained overdenture with ball attachmentsLink provided by the sponsor.
- A within-subject clinical trial on the conversion of mandibular two-implant to three-implant overdenture: Patient-centered outcomes and willingness to payLink provided by the sponsor.
- Comparison of masticatory efficiency, patient satisfaction for single, two, and three implants supported overdenture in the same patient: A pilot studyLink provided by the sponsor.
- Clinical and radiographic evaluation of three-implant-retained mandibular overdentures: a 3-year retrospective studyLink provided by the sponsor.
- Vitamin D and intestinal calcium absorptionLink provided by the sponsor.
- Is Low Serum Vitamin D Associated with Early Dental Implant Failure? A Retrospective Evaluation on 1625 Implants Placed in 822 PatientsLink provided by the sponsor.
- Individual participant dataSharing planned: No. This study is a retrospective observational study using existing patient records. Individual participant data will not be shared to protect patient confidentiality and privacy, and due to restrictions in accessing historical medical records
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin D Deficiency and Implant Assesment, run by Mansoura University at 1 site in Egypt.
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 6 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: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2025. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
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?
Correlation between serum vitamin D levels and radiographic marginal bone loss around unsplinted mandibular implant overdentures (time frame: Baseline (prosthetic loading), 6 months, 12 months after loading (T0,T6,T12)). 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 30 Sep 2025.