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

NCT ID: NCT06806423

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-11
• Study Completion Date: 2024-10-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control Group

12 implants were placed immediately after teeth extraction.

Group Type: ACTIVE_COMPARATOR

Immediate Dental Implant Placement without Adjunctive Treatments

Intervention Type: PROCEDURE

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.

Vitamin D Group

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

Group Type: EXPERIMENTAL

Immediate Dental Implant Placement with Topical Vitamin D Gel Application

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Suez Canal University

OTHER

Sponsor Role: lead

Responsible Party

Bassem M. Ayyad

Bassem M. Ayyad

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bassem M. Ayyad

Role: PRINCIPAL_INVESTIGATOR

Suez Canal University

Locations

Oral & Maxillofacial Surgery Department, Faculty of Dentistry, Suez Canal University

Ismailia, Ismailia Governorate, Egypt

Countries

Egypt

Other Identifiers

Vit D on Dental Implants

Identifier Type: -

Identifier Source: org_study_id