Effect of Vitamin D on the Clinical and Radiographic of Unsplinted Mandibular Implant Overdentures
NCT ID: NCT07200011
Last Updated: 2025-09-30
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
40 participants
OBSERVATIONAL
2025-09-01
2025-10-20
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Vitamin D-deficient (<20 ng/mL)
Participants with serum vitamin D \<20 ng/mL
Observational: Serum Vitamin D Levels
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
Vitamin D-sufficient (≥30 ng/mL)
Participants with serum vitamin D ≥30 ng/mL
Observational: Serum Vitamin D Levels
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
Interventions
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Observational: Serum Vitamin D Levels
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
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
40 Years
60 Years
MALE
No
Sponsors
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Mansoura University
OTHER
Responsible Party
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Rahma elhussany mohammed
Lecturer, Department of Prosthodontics, Mansoura faculty of Dentistry, Egypt
Locations
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Faculty of Dentistry, Mansoura University
Al Mansurah, Dakahlia Governorate, Egypt
Countries
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Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Related Links
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Direct procedure for connecting a mandibular implant-retained overdenture with ball attachments
A within-subject clinical trial on the conversion of mandibular two-implant to three-implant overdenture: Patient-centered outcomes and willingness to pay
Comparison of masticatory efficiency, patient satisfaction for single, two, and three implants supported overdenture in the same patient: A pilot study
Clinical and radiographic evaluation of three-implant-retained mandibular overdentures: a 3-year retrospective study
Vitamin D and intestinal calcium absorption
Is Low Serum Vitamin D Associated with Early Dental Implant Failure? A Retrospective Evaluation on 1625 Implants Placed in 822 Patients
Correlation of Serum Vitamin D with Crestal Bone Level in Dental Implant Patients Using CBCT: A Clinical Retrospective Study
Other Identifiers
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R.25.07.10
Identifier Type: -
Identifier Source: org_study_id