Clinical trial NCT06654518: Prediction of Primary Dental Implant Stability Preoperatively Using CBCT of the Planned Implant Site.
Official title: The Prognostic Accuracy of Bone Density and Alveolar Ridge Width Estimated by CBCT in Predicting Primary Implant Stability: Clinical Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prediction of Primary Implant Stability From Bone Quality Obtained Prior to Implant Placement Using CBCT
Keywords: bone density, alveolar ridge width, insertion torque, resonance frequency analysis
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-10-23
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study aimed to assess whether preoperative characteristics of the implant site, such as bone density and alveolar ridge width, assessed using cone beam computed tomography (CBCT), are significantly associated with primary stability, as assessed by resonance frequency analysis (RFA) and final insertion torque value (ITV), and thereby investigate if it is feasible to predict primary stability preoperatively using this form of radiologic examination of the planned implant site. All patients underwent preoperative CBCT. The bone density and alveolar ridge width were assessed. The primary implant stability quotient (ISQ) values were assessed by a wireless magnetic-based Osstell ISQ RF Analyzer.

Detailed description: The quality and quantity of bone available for placing dental implants are key factors in the success of these implants. Implants placed in bone with insufficient quantity or poor quality have a higher risk of failure. As a result, evaluating the bone structure prior to implant placement surgery is essential for proper planning of the treatment.

Eligibility criteria: Inclusion Criteria:

1. Patients must be free from any systemic conditions that would contraindicate dental implant surgery.
2. Good oral hygiene.
3. Age above 18 years.
4. The planned implant site must have sufficient alveolar bone volume.

Exclusion Criteria:

1. Patients who have undergone radiation therapy to the head and neck region within the last 12 months.
2. Uncontrolled diabetes.
3. Patients who underwent dental extractions or bone augmentation at the planned implant site during the last six months in order to guarantee uniform bone maturation.
4. Severe clenching or bruxism is present.
5. Acute infection at the planned implant site.
6. Implant sites requiring a procedure for bone gain.

Primary outcomes:
measure: Primary Implant Stability Using Resonance Frequency Analysis (RFA)and final insertion torque value (ITV)
timeFrame: Measured immediately after implant placement
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura.
country: Egypt
facility: Faculty of Dentistry, Mansoura University
state: Dakahlia
Study officials:
affiliation: Faculty of dentistry, Mansoura university
name: Soaad T Badawi, Lecturer, Oral Surgery, MU
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Elio Oliveros J, Del Canto Diaz A, Del Canto Diaz M, Orea CJ, Del Canto Pingarron M, Calvo JS. Alveolar Bone Density and Width Affect Primary Implant Stability. J Oral Implantol. 2020 Aug 1;46(4):389-395. doi: 10.1563/aaid-joi-D-19-00028.