Effect of Vitamin D on the Clinical and Radiographic of Unsplinted Mandibular Implant Overdentures

NCT07200011 | Active Not Recruiting

• 1 other identifier: R.25.07.10
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Vitamin D Deficiency; Implant Assesment; Radiography; Clinical and Radiographic Effect

Keywords

Vitamin D, marginal bone loss, mandibular implant overdenture, un-splinted implants, LOCATOR attachments,periapical radiographs.

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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.

  Baseline (prosthetic loading), 6 months, 12 months after loading T0, T6,T12

• Prosthesis-related factors, including stability, retention, and occlusion, were assessed clinically.

  Baseline (prosthetic loading), 6 months, 12 months after loading T0, T6,T12

Study Arms (2)

Vitamin D-deficient (<20 ng/mL)

Participants with serum vitamin D \<20 ng/mL

Other: Observational: Serum Vitamin D Levels

Vitamin D-sufficient (≥30 ng/mL)

Participants with serum vitamin D ≥30 ng/mL

Other: Observational: Serum Vitamin D Levels

Interventions

Observational: Serum Vitamin D Levels OTHER

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-deficient (<20 ng/mL); Vitamin D-sufficient (≥30 ng/mL)

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of Dentistry, Mansoura University

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

Related Links

• 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

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, Department of Prosthodontics, Mansoura faculty of Dentistry, Egypt

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 30, 2025
• Study Start: September 1, 2025
• Primary Completion: October 15, 2025
• Study Completion: October 20, 2025
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)