Hydraulic Pressure Sinus Lift Versus Piezoelectric Lift Via Lateral Approach: A Randomized Controlled Clinical Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Alexandria University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- radiographic appraisal of gain in alveolar bone height
Study Overview
Brief Summary
the study aims to assess the effectiveness of hydraulic pressure sinus lift via lateral wall approach, versus piezoelectric surgery in patients with deficient posterior maxilla.
Detailed Description
This study involves a randomized clinical trial of 20 participants with less than 6 mm bone height in the posterior maxilla in need of Maxillary Sinus Floor Augmentation using the lateral window approach. Patients will be randomly assigned to two groups; the HPLT Group which include 10 patients who will undergo hydraulic pressure for osteotomy preparation for lateral sinus lifting technique, and the PSLT Group which include 10 patients managed using piezoelectric surgery. Clinical and radiographic assessment of bone augmentation, as well as intraoperative biological complications and postoperative complications were recorded.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Masking Description
patients were allocated in a 1:1 ratio using an on-site computer software system with concealed allocation through sequentially numbered, opaque, sealed envelopes (SNOSE). This was a double-blind study, so neither the statistical analyst nor the patients were aware of the surgical procedure
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •The study included patient with deficient posterior maxilla with less than 6mm of bone height confirmed by a pre-operative tomographic scan. All healthy (ASA I, II) non- smoker patients were eligible for the study. The absence of uncontrolled diabetes, systemic illnesses, sinusitis, immune deficiency disorders, were also required for inclusion.
Exclusion Criteria
- •Patients with sinus infection, neoplasm or a large cyst of the sinus, or those who previously underwent a Caldwell-Luc surgery for the same surgical site were excluded
Arms & Interventions
HPLT Group
patients with posterior deficient maxilla managed with osteotomy for lateral sinus floor augmentation using the Hydraulic Pressure Lifting Technique with A.I drill and hydraulic-powered Aqua-Lifter (OLA system) were assigned to HPLT Group
Intervention: Hydraulic Pressure Lifting Technique (Device)
PSLT Group
posterior deficient maxilla managed with osteotomy for lateral sinus floor augmentation using Piezo-Surgical Lifting Technique were assigned to PSLT Group
Intervention: Piezo-Surgical Lifting Technique (Device)
Outcomes
Primary Outcomes
radiographic appraisal of gain in alveolar bone height
Time Frame: 6 months
Postoperative radiographic appraisal was conducted by an immediate postoperative CBCT, followed by other one after 6 postoperative month's. Measurements of the bone height was conducted from the alveolar crest to the floor of the maxillary sinus on a cross-section view of the CBCT (Carestream Health, Rochester, NY). Radiographic assessment of the amount of bone height gain in 6 months period was performed by comparing the bone height measurements between the 6 postoperative months' CBCT with the preoperative scan.
Secondary Outcomes
- incidence of membrane perforation(Until the end of the operation)