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Alveolar Bone LossNCT03944811

Bone Height Gain Following Transcrestal Sinus Floor Elevation Using Piezoelectric Surgery Versus The Conventional Osteotome Technique

A study testing piezoelectric device and Summers technique in people with Alveolar Bone Loss, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 20 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Alveolar Bone Loss
What is being tested?
piezoelectric device and Summers technique
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteEgypt
Study dates
1 Sep 2019to 1 Apr 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • • Patients having one missing upper posterior tooth residual bone height beneath maxillary sinus from 5-8 mm.
  • A minimum of 6 mm residual bone width at site of implant placement.
  • The recipient site of the implant should be free from any pathological conditions.
  • No diagnosed bone disease or medication known to affect bone metabolism.
  • Patients who are cooperative, motivated and hygiene conscious.
  • Patients having adequate inter-occlusal space of 8-10 mm.

Who cannot join

  • Systemic conditions/diseases that contraindicate surgery.
  • Radiation therapy in the head and neck region or chemotherapy during the 12 months prior to surgery.
  • Patients who have any habits that might jeopardize the osseointegration process, such as current smokers.
  • Patients with parafunctional habits that produce overload on implant, such as bruxism and clenching.
  • Patients that have any pathology in the maxillary sinuses.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Ahmed Hassan El Barbary

    Cairo

Other trials in Egypt

About this study

Official title: Evaluation of Bone Height Gain Following Transcrestal Sinus Floor Elevation Using Piezoelectric Surgery Versus The Conventional Osteotome Technique in Patients With Atrophic Posterior Maxillae: A Randomized Controlled Clinical Trial

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.

Read the detailed description

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.

Being tested
piezoelectric device, Summers technique
Medical subject headings
Alveolar Bone Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • piezoelectric deviceProcedure or surgery

    crestal approach will be used to augment the maxillary sinus with simultaneous implant placement

  • Summers techniqueProcedure or surgery

    Summers technique

Study groups in NCT03944811
Study groupRoleWhat they receive
Transcrestal sinus floor elevation using Summers techniqueActive comparatorNot described
Receives: Procedure: Summers technique
Transcrestal sinus floor elevation using piezoelectric surgeryExperimentalNot described
Receives: Procedure: piezoelectric device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Amount of bone height gain

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2019
  2. Study start1 Sep 2019
  3. Primary completion22 Jan 2021
  4. Study completion1 Apr 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03944811
Sponsor's protocol ID
29011
Status last verified
Oct 2021
First submitted
7 May 2019
Last updated
5 Nov 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing piezoelectric device and Summers technique in people with Alveolar Bone Loss, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Amount of bone height gain (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2021.

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