Assessment of Implants Placed Simultaneously With Maxillary Sinus Bone Augmentation Using Two Different Sinus Elevation Techniques: A Randomized Control Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Implant Stability
Study Overview
Brief Summary
A clinical Trial, comparing two different techniques to elevate the maxillary sinus floor membrane to allow for simultaneous dental implant placement in the severely atrophied maxillary ridges.Both using allogenic bone substitute as the bone graft material. One technique is the open lateral window technique and the second is the closed crestal technique.
Detailed Description
Following extraction of posterior teeth in the maxillary arch, maxillary sinus pneumatization may pause a difficulty for dental implant placement. This difficulty may be overcome by maxillary sinus elevation with or without bone grafting or the use of short implants. Yet the literature available does not give conclusive answers as to what is the best approach for each clinical situation.
Aim of this study is to evaluate implants placed simultaneously with maxillary sinus bone augmentation using two different sinus floor elevation techniques. Null Hypothesis: There is no statistically significant difference between implants placed with crestal sinus approach and lateral sinus floor elevation, using bone grafting in both techniques, regarding implant stability and radiographic bone height gain.
Alternative Hypothesis: There is statistically significant difference between implants placed with crestal sinus approach and lateral sinus floor elevation, using bone grafting in both techniques, regarding implant stability and radiographic bone height gain.
Thirty implants in patients having posterior edentulism with maxillary sinus pneumatization were studied. All patients were be randomly allocated into two groups, group 1 (test group) had dental implants placed after crestal approach for sinus elevation, while group 2 (control group) had dental implants placed after lateral approach for maxillary sinus elevation. Both groups received allogenic bone grafts in the elevated sites. To assess implant stability, a resonance frequency analysis (RFA) device was used, for each implant the implant stability quotient (ISQ) values was measured on four sites over the implant. Mean values were calculated for each implant from the four recorded values. ISQ values were recorded immediately post-implant insertion, 9 months (after delivery of the final prosthesis) and at 12 post- operative. Cone Beam Computed Tomography (CBCT)s were made at 6 and 12 months post-operative to evaluate the radiographic bone changes in vertical dimension of bone height gained around each implant.
Steps of the clinical Procedures:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Masking Description
it is a double blinded study, both the outcome assessor and statistician will be blinded
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients who have at least one missing posterior maxillary tooth with sound adjacent teeth.
- •Adults above the age of
- •Bone height from 4mm to 7mm under the maxillary sinus assessed in CBCT.
- •Good oral hygiene.
- •Patient accepts to sign an informed consent.
Exclusion Criteria
- •Smokers (more than 10 cigarettes per day).
- •Medically compromised patients.
- •Patients with active infection related at the site of implant/bone graft placement.
- •Patients with untreated active periodontal diseases.
- •Patients with parafunctional habits.
- •Acute or chronic sinusitis.
Outcomes
Primary Outcomes
Implant Stability
Time Frame: immediate postoperative- 9 months- 12 months
Resonance Frequency analysis (RFA) a Device Named "Ostell" Device for measuring RFA
Secondary Outcomes
- Radiographic bone gain(immediate post-operative- 6 months-12 months)
Investigators
Hebatallah Abdo's Elsaid Mattar
Assisstant Lecturer
Misr International University