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

NCT06806423 | Completed

• 1 other identifier: Vit D on Dental Implants
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Implant Stability (ISQ)

  Implant stability was measured using the Osstell ISQ device, providing precise, non-invasive, and objective assessments for monitoring osseointegration. A SmartPeg was securely attached to the implant, and a probe connected to the device was positioned at a right angle toward the implant. The Implant Stability Quotient (ISQ) was measured on a scale from 1 to 100, with values above 70 indicating high stability, 60-69 indicating medium stability, and values below 60 suggesting low stability. Stability was assessed immediately after surgery and then reassessed at 3 and 6 months.

  Baseline, 3, and 6 months postoperatively

• Bone Density

  Radiographic evaluations were conducted using direct digital periapical radiographs, captured with the KaVo Scan eXam™ One system and Rinn XCP device. Radiographs were taken immediately postoperatively, and at 3 and 6 months. Bone density around the implants was analyzed using IDRISI Kilimanjaro software, which measured grayscale values to quantify density. Bone density was quantified on a 255-point grayscale, with 0 representing black regions and 255 representing white regions. Two zones were assessed: the osseointegration zone adjacent to the implant and the surrounding bone. This approach provided precise monitoring of bone density changes over time.

  Baseline, 3 and 6 months postoperatively

Secondary Outcomes (3)

• Peri-implant Probing Depth (PD)

  3 and 6 months postoperatively

• Bleeding Index (BI)

  3 and 6 months postoperatively

• Visual Analogue Scale for Pain (VAS)

  Days 1, 3, and 7 postoperatively

Study Arms (2)

Control Group

ACTIVE COMPARATOR

12 implants were placed immediately after teeth extraction.

Procedure: Immediate Dental Implant Placement without Adjunctive Treatments

Vitamin D Group

EXPERIMENTAL

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

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

Interventions

Immediate Dental Implant Placement without Adjunctive Treatments 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.

Control Group

Immediate Dental Implant Placement with Topical Vitamin D Gel Application 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.

Vitamin D Group

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

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

Ismailia, Ismailia Governorate, 41522, Egypt

Location

Study Officials

• Bassem M. Ayyad

  Suez Canal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Bassem M. Ayyad

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 4, 2025
• Study Start: October 11, 2022
• Primary Completion: January 1, 2024
• Study Completion: October 1, 2024
• Last Updated: February 11, 2025

Record last verified: 2025-02

Locations

EG (1)