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

Suez Canal University

Status: Completed

Conditions: Tooth Extraction; Implant Osseointegration; Immediate Dental Implant; Vitamin D

Treatments: Procedure: Immediate Dental Implant Placement without Adjunctive Treatments; Procedure: Immediate Dental Implant Placement with Topical Vitamin D Gel Application

Study type: Interventional

Funder types: Other

Identifiers

NCT06806423

Vit D on Dental Implants

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 21 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Both genders.
2. Middle-aged adults (from 21 years to 40 years).
3. Healthy American Society of Anesthesiologists patients (ASA I).
4. Patients with teeth or roots indicated for extraction at the lower anterior region.

Exclusion criteria

1. Pregnant or lactating females.
2. Patients with parafunctional or bad oral habits such as bruxism or smoking (more than 10 cigarettes per day).
3. Patients with bad oral hygiene.
4. Patients with severe periodontal diseases (severe vertical or horizontal bone loss).
5. Pathological changes or infections related to teeth indicated for immediate implant placement.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups

Control Group

Active Comparator group

Description:

12 implants were placed immediately after teeth extraction.

Treatment:

Procedure: Immediate Dental Implant Placement without Adjunctive Treatments

Vitamin D Group

Experimental group

Description:

12 implants were placed immediately after teeth extraction, combined with topical vitamin D gel application.

Treatment:

Procedure: Immediate Dental Implant Placement with Topical Vitamin D Gel Application