Dental Implant, Dental Implant Placement, IMPLANTATION, Peri-Implant Tissues
Conditions
Keywords
flapless surgery, mini-incision surgery, peri-implant soft tissue, dental implant
Brief summary
evaluate the clinical efficacy of the flapless mini-incision method compared to conventional flap and flapless punch methods
Interventions
PROCEDUREFlapless punch
use of flapless puch surgery to place dental implants
PROCEDUREFlapless mini-incision
Use of a flapless mini-incision to place a dental implant
PROCEDUREConventional flap
Use of a conventional surgical flap to place a dental implant
Sponsors
Alaa Emara
King Saud University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients with adequate bone height and width at the site of implant 120 placement, and good quality bone to support a primary stability of at least 30 Ncm and D2 bone quality according to Lekholm and Zarb classification), based on preoperative radiographic assessment * Clinical evidence of optimal periodontal health with no active periodontal disease in adjacent teeth * No history of systemic illnesses that could affect bone health and wound heal- ing (e.g. uncontrolled diabetes mellitus, osteoporosis, renal osteodystrophy…etc.) * No history of or requirement for bone grafting and augmentation at the implant site * Willingness to participate in the study and attend prescribed follow-up appointments
Exclusion criteria
* Patients with history of radiation therapy for head and neck cancer * Patients with history of allergy and hypersensitivity to local anesthetic agents, and biomaterials used in dental implants * Pregnant women and lactating mothers * History of smoking (\>2 cigarettes per day) * Patients under treatment with anti-resorptive or anti-neoplastic medication such as bisphosphonates, chemotherapeutic agents, and monoclonal antibodies (e.g. Denosumab
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain score | 18 months postoperatively | Assessment of patient's pain level using Visual Analog Scale (VAS) which would be compared between groups. VAS is a visual scale 0 to 10 with 10 the highest pain score and 0 the lowest, the patient is asked to identify the pain level at the different timestops for comparison between groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Soft-tissue healing | 18 months postoperatively | Assess the healing of overlaying soft tissue. Check for signs of infection , swelling, dehiscnce or inflammation |
| Radiographic bone level | 18 months postoperatively | Assessment of bone level postoperatively. A CBCT is ordered to assess bone density in hounsfeld unitsto assess level of bone maturation. This would then be compared across groups and between different time points to show bone deposition and healing. |
Countries
Saudi Arabia
Outcome results
None listed