Oral & Maxillofacial Surgery Department, Faculty of Dentistry, Suez Canal University
Ismailia, Ismailia Governorate, 41522, Egypt
NCT Number: NCT06806423
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.
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Notify Me21 year–40 year
All sexes
Interventional
Not applicable
Ismailia, Ismailia Governorate, 41522, Egypt
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:
Postoperative and Follow-up Evaluations:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Baseline, 3, and 6 months postoperatively
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.
Time frame: Baseline, 3 and 6 months postoperatively
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.
Time frame: 3 and 6 months postoperatively
Peri-implant probing depth was measured to assess the soft tissue healing surrounding the implants. A periodontal probe was gently inserted into the space between the implant healing abutments and the soft tissue at six sites: mesio-buccal, buccal, disto-buccal, mesio-palatal, palatal, and disto-palatal. Measurements were taken at 3 and 6 months postoperatively. The depth, recorded in millimeters, provided a numerical index of peri-implant tissue health, with shallow depths indicating healthy tissues and deeper pockets suggesting potential peri-implant disease. This straightforward method allowed for a comprehensive evaluation of implant sites over time.
Time frame: 3 and 6 months postoperatively
The Bleeding Index was used to assess the soft tissue healing surrounding the implants. A periodontal probe was gently inserted into the space between the implant healing abutments and the soft tissue at six sites: mesio-buccal, buccal, disto-buccal, mesio-palatal, palatal, and disto-palatal. Measurements were taken at 3 and 6 months postoperatively. The presence or absence of bleeding at these sites served as an indicator of tissue health, with bleeding suggesting inflammation or compromised healing, and no bleeding indicating healthy soft tissues. This method provided valuable insights into the status of soft tissue healing around the implants.
Time frame: Days 1, 3, and 7 postoperatively
The VAS is a commonly used questionnaire for measuring pain intensity. It consists of a 10-centimeter horizontal line with endpoints labeled to represent the extremes of pain, typically "no pain" on the left and "unimaginably unspeakable pain" or similar descriptors on the right. Patients are asked to mark a point on the line that reflects their current level of pain. The distance in centimeters from the "no pain" end to the patient's mark provides a numerical value representing the severity of their pain, offering a simple and quantifiable method for pain assessment.
Suez Canal University
Other
Clinical and Radiographic Evaluation of Topical Vitamin D Application on Immediate Dental Implants: a Randomized Clinical Trial
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