An interventional study of piezoelectric device and Summers technique in Alveolar Bone Loss, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-05.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
Missing teeth usually result in functional and cosmetic deficits. Traditionally, they have been restored with dentures or fixed bridges. However, dental implants represent an excellent alternative which rely on the maintenance of a direct structural and functional connection between living bone and implant surface, which is termed osseointergration. When sufficient bone is available in maxilla, implant rehabilitation has shown high success rates of 84-92 %. Atrophy of the alveolar crest and pneumatization of the maxillary sinus limits the quality and quantity of residual bone, therefore complicating the placement of implants in the posterior maxillary area.
Many solutions were suggested to overcome the problem of placing implants in the vertically compromised bone height in the maxillary posterior region. These solutions include the placement of short wide implants, long tilted zygomatic implants, vertical ridge augmentation and elevation of the sinus membrane to increase the available length for implant placement.
The use of short implants (\<10 mm in length) is a reasonable solution that reduces the risk of interference with anatomic structures and claimed to have success rate as high as conventional implants. However, short implants have faced many challenges due to less bone-to-implant contact, more crestal bone resorption, and compromised crown-to-implant ratio. Another treatment option is the use of zygomatic implants. However, many complications may be associated with zygomatic implants such as oro-antral fistula formation, maxillary sinusitis, and peri-implant bleeding.
Vertical augmentation of the resorbed alveolar ridge is another treatment option. It can be done by onlay grafting, distraction osteogenesis and guided bone regeneration. Although success rates of various bone grafting techniques are high, there are many inherent disadvantages which include prolonged treatment times, raised treatment costs and increased surgical invasion associated with patient morbidity and potential complications.
To overcome these problems, elevation of the sinus membrane techniques were proposed, it can be performed either through a lateral window, or via a crestal access. The selection between these two techniques is mainly based on the remaining residual vertical subsinus bone height. Lateral approach of sinus elevation is indicated when the residual bone height is of 4 mm or less, while the crestal approach is used in case of residual ridge of 5-6 mm.
Many long term studies and systematic reviews have showed that osteotome mediated sinus floor elevation (OSFE) technique is a highly predictable method for rehabilitation of patients with atrophied posterior maxilla with survival rates ranging from 92 % to 100 %. However, endoscopic studies have demonstrated the risk of membrane perforation while performing transalveolar sinus floor elevation. Moreover, the Summers technique can cause some complications as headache and paroxysmal positional vertigo.
The piezoelectric internal sinus elevation (PISE) technique was first introduced by Sohn in 2009. Using piezoelectric ultrasonic vibration (25-30 kHz), the piezosurgery device cuts only mineralized structures precisely without cutting soft tissues even in case of accidental contact. Moreover, the cavitation effect produces a hydropneumatic pressure in the physiological saline solution that leads to atraumatic sinus membrane elevation. Another advantage of piezosurgery is its precision as the movement of the piezosurgery knife is very small, so the cutting precision is great and the patients discomfort is minimal. In addition, the air-water cavitation effect of the piezoelectric device sustains a blood-free surgical field which improves visualization of the surgical field. This technique overcomes the problem of benign paroxysmal positional vertigo caused by malleting during the osteotome mediated sinus floor elevation.
297 studies on the registry are indexed under Alveolar Bone Loss; 76 are open to participants now.
This study's enrollment of 24 is close to the median of 25 across 254 interventional studies indexed under Alveolar Bone Loss.
Browse Alveolar Bone Loss studies →Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients having one missing upper posterior tooth residual bone height beneath maxillary sinus from 5-8 mm.
Exclusion Criteria:
Systemic conditions/diseases that contraindicate surgery.
Procedure: Summers technique
Procedure: piezoelectric device
crestal approach will be used to augment the maxillary sinus with simultaneous implant placement
Summers technique
Amount of bone height gain
Time frame: 6 months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Cairo University