NCT06806423

Clinical and Radiographic Evaluation of Topical Vitamin D on Immediate Dental Implants

Clinical and Radiographic Evaluation of Topical Vitamin D Application on Immediate Dental Implants: a Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Suez Canal University · Academic / Other
• Sex: All
• Age: 21 Years – 40 Years
• Healthy volunteers: Accepted

Summary

This study evaluates the clinical and radiographic outcomes of topical vitamin D application on immediate dental implants in patients undergoing single-rooted tooth extraction in the anterior mandibular region.

Detailed description

This randomized clinical trial investigates the clinical and radiographic outcomes of topical vitamin D application on immediate dental implants in patients undergoing single-rooted tooth extraction in the anterior mandibular region. Osseointegration, the direct structural and functional connection between bone and implant surface, is a critical factor in implant success. Recent studies suggest that vitamin D3 plays a significant role in bone metabolism, promoting osteoblast differentiation and enhancing mineralization. The aim of this study is to evaluate whether the adjunctive use of topical vitamin D3 gel can improve implant stability, peri-implant soft tissue health, and bone density around immediate dental implants. Surgical Protocol: * All surgical procedures were performed under strict infection control protocols at the Faculty of Dentistry, Suez Canal University. * Patients rinsed with 0.1% chlorhexidine (Hexitol antiseptic mouthwash) for one minute before the procedure. * The perioral area was disinfected using 10% povidone-iodine (Betadine). * Local anesthesia was administered using 4% articaine hydrochloride with 1:100,000 epinephrine (Artinibsa) via the infiltration technique. * Atraumatic tooth extractions were performed using periotomes and anterior forceps, preserving the surrounding alveolar bone. * The dimensions of the extraction socket and residual bone were evaluated using a periodontal probe to ensure compatibility with the implant size. * Osteotomy preparation followed a standardized protocol using sequential drills at 950-1100 rpm with 35 Ncm torque under copious irrigation to prevent overheating and bone necrosis. * Study Group: Sterile vitamin D3 (calcitriol) gel was applied to both the implant surface and the osteotomy site immediately before implant placement. * Control Group: No additional adjuncts were applied before implant placement. * ROOTT R-line implants were selected based on socket dimensions. * Implants were inserted into fresh extraction sockets, and proper alignment was meticulously confirmed to ensure ideal positioning. Postoperative and Follow-up Evaluations: * Clinical Assessments: * Pain levels were measured using the Visual Analog Scale (VAS) on postoperative days 1, 3, and 7. * Probing depth and bleeding index were recorded at 3 and 6 months to assess peri-implant soft tissue health. * Implant stability was evaluated using the Osstell ISQ device at baseline, 3 months, and 6 months. * Radiographic Assessments: * Standardized digital periapical radiographs were taken at baseline, 3 months, and 6 months to monitor bone density changes around the implants. * Bone density analysis was performed using IDRISI Kilimanjaro software, which measured grayscale values to provide quantitative bone density assessments.

Conditions

• Immediate Dental Implant
• Implant Osseointegration
• Vitamin D
• Tooth Extraction

Interventions

Type	Name	Description
PROCEDURE	Immediate Dental Implant Placement without Adjunctive Treatments	Atraumatic extractions using periotomes and anterior forceps. Osteotomy was prepared with a standardized drilling sequence under copious irrigation. ROOTT R-line implants were selected based on socket dimensions. No topical vitamin D3 was applied. Implants were placed into fresh extraction sockets.
PROCEDURE	Immediate Dental Implant Placement with Topical Vitamin D Gel Application	The same procedure as the control group, with the addition of sterile topical vitamin D3 (calcitriol) gel applied to both the implant surface and osteotomy site immediately before implant placement.

Timeline

• Start date: 2022-10-11
• Primary completion: 2024-01-01
• Completion: 2024-10-01
• First posted: 2025-02-04
• Last updated: 2025-02-11

Locations

1 site across 1 country: Egypt