Hydrodynamic Piezoelectric Technique in Internal Sinus Lift
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-50
SponsorHams Hamed Abdelrahman
About this trial
Background: The use of hydrodynamic piezoelectric techniques for trans crestal / internal sinus lift with simultaneous implant placement has gained popularity as a safe and minimally invasive technique for managing the posterior edentulous maxilla, particularly in cases with sinus pneumatization. This method offers a controlled elevation of the Schneiderian membrane while reducing the risk of perforation compared to conventional techniques. Additionally, it minimizes postoperative discomfort and oedema, leading to better acceptance and satisfaction by the patients. In contrast to traditional osteotome tapping procedures, the hydrodynamic piezoelectric technique enhances surgical outcomes while preserving vital anatomical structures, making it a superior alternative in implant dentistry. This study aims to evaluate the use of the hydrodynamic piezoelectric technique in internal sinus lifting with simultaneous implant placement in comparison to the conventional osteotome technique.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with edentulous free end or bounded posterior maxilla that require implant supported restoration.
Patients indicated to internal sinus lifting, where insufficient residual alveolar bone height from the alveolar crest to the floor of the maxillary sinus is found.
Patients with residual alveolar bone height that ranges from 5-7 mm according to the tomographic radiographic examination.
A good standard of oral hygiene.
Disqualifiers
Patients with residual alveolar bone height less than 5 mm according to the tomographic radiographic examination.
Patients with residual alveolar bone height more than 8 mm according to the tomographic radiographic examination, which is not indicated to sinus lifting.
Patient with active sinus infection or sinus pathology.
History of Oral or intravenous bisphosphonate therapy or any treatments with other medications that may interfere with bone metabolism within the past 12 months.
Trial design
Design model
Parallel
Treatments tested in this trial
conventional osteotome technique
Procedure/SurgeryPatients indicated for internal sinus lifting with simultaneous implant placement, where sinus elevation is conducted with regular manual osteotomes.
Hydrodynamic Piezoelectric technique
Procedure/SurgeryPatients indicated for internal sinus lifting with simultaneous implant placement, where sinus elevation is conducted with Hydrodynamic Piezoelectric technique.
Treatment groups
22 Participants
are divided into 2 treatment groupsGroup A: conventional osteotome techniqueActive comparator 1 intervention
Group B: osteotome with hydrodynamic piezoelectricExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in pain scores
Pain will be evaluated, using visual analogue scale (VAS) as follows: (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe).
Time frame
at 7, 14, and 21 days2
Change in wound healing
The wound healing will be assessed based on the Modified Healing Index. The Wound Healing Index (WHI) evaluates preimplant soft tissue wound healing with scores from 1 to 3. On this scale, a score of 1 indicates ordinary healing with the absence of gingival edema, erythema, suppuration, patient discomfort, and flap dehiscence. A score of 2 indicates ordinary healing with slight gingival edema, erythema, patient discomfort, and flap dehiscence, but no suppuration and a score of 3 corresponds to poor wound healing with significant gingival edema, erythema, patient discomfort, suppuration, and flap dehiscence, or any suppuration
Time frame
at 7, 14, and 21 days3
change in implant stability
Implant Stability Quotient (ISQ) will be measured during the operative stage, while the secondary stability quotient will be measured 6-months post-operative during the prosthetic phase preparation using Ostell device.
Time frame
baseline and 6 monthsSecondary outcomes
1
Change in Alveolar Process height gain
The baseline residual alveolar bone height will be measured in the preoperative scan from the alveolar crest to the maxillary sinus floor. Immediate postoperative alveolar bone height will be measured to outline the effectiveness of sinus membrane elevation using CBCT
Time frame
baseline and 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Hams Hamed Abdelrahman
Lead sponsor
Alexandria University
Sponsor institution
Source ClinicalTrials.gov
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