Clinical trial NCT06806423: Clinical and Radiographic Evaluation of Topical Vitamin D on Immediate Dental Implants
Official title: Clinical and Radiographic Evaluation of Topical Vitamin D Application on Immediate Dental Implants: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immediate Dental Implant
Implant Osseointegration
Vitamin D
Tooth Extraction
Keywords: Immediate dental implants
Calcitriol
1,25-dihydroxycholecalciferol
Osseointegration
Implant stability
Bone density
IDRISI Kilimanjaro software
Lead sponsor: Suez Canal University
Sponsor class: OTHER
First posted: 2025-02-04
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Implant Stability (ISQ)
timeFrame: Baseline, 3, and 6 months postoperatively
measure: Bone Density
timeFrame: Baseline, 3 and 6 months postoperatively
Secondary outcomes:
measure: Peri-implant Probing Depth (PD)
timeFrame: 3 and 6 months postoperatively
measure: Bleeding Index (BI)
timeFrame: 3 and 6 months postoperatively
measure: Visual Analogue Scale for Pain (VAS)
timeFrame: Days 1, 3, and 7 postoperatively
Other outcomes:
Locations:
city: Ismailia
country: Egypt
facility: Oral & Maxillofacial Surgery Department, Faculty of Dentistry, Suez Canal University
Study officials:
affiliation: Suez Canal University
name: Bassem M. Ayyad
role: PRINCIPAL_INVESTIGATOR
References: