AzTrials
AzTrials

Sinus PerforationNCT04618588

Computer Guided Low Window Sinus Lift Technique

A study testing Low Window Sinus Lift technique in people with Sinus Perforation, run by Hams Hamed Abdelrahman 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
Search all trials

Trial summary

The study group included 12 patients that were treated using the low window lateral sinus lift technique with simultaneous implant placement. This was facilitated using a CAD-CAM generated surgical guide. Read more about this study

Who is it for?
Ages 20 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Sinus Perforation
What is being tested?
Low Window Sinus Lift technique
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteEgypt
Study dates
1 Jan 2019to 17 Dec 2019
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 requiring implant placement in the posterior maxilla (Kennedy Classification: Class 1 and Class 2).
  • Age between 20-60 years irrespective of the gender.
  • Tooth extractions at the implant sites were performed at least 4 months before surgery.
  • Residual bone height between the alveolar bone crest and the sinus floor ranges from 4 to 6 mm.
  • Patients who are willing and fully capable to comply with the study protocol.

Who cannot join

  • Maxillary sinus pathologies (sinusitis, long standing nasal obstruction).
  • Any disease contraindicating surgery (e.g. uncontrolled diabetes).
  • Heavy smokers.
  • Acute oral infections.
  • Untreated periodontal disease.
  • Poor oral hygiene.
  • A history of radiotherapy or chemotherapy of the head and neck region.
  • Pregnancy.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University

    Alexandria

Other trials in Egypt

About this study

Official title: Evaluation of Computer-guided Low Window Sinus Lift Technique (A Clinical Trial)

The study group included 12 patients that were treated using the low window lateral sinus lift technique with simultaneous implant placement. This was facilitated using a CAD-CAM generated surgical guide. Subjective assessment on postoperative pain and swelling as well as objective assessment of implant stability, vertical bone height gained and complications such as Schneiderian membrane perforation rates and bleeding.

Read the detailed description

Presurgical assessment of each patient was performed. Preoperative impressions were taken and study models were mounted. Orthopantogram (OPG) and cone beam computer tomography (CBCT) of the targeted areas were also done in order to evaluate residual bone height between the alveolar bone crest and the sinus floor, residual ridge width, bone quality and planning the number, size and position the implants.

Designing the surgical guide was performed using In2Guide™ system powered by OnDemand3D™.

The low window design was also planned where the lower osteotomy line will be flushed with the floor of the sinus, the upper line is 6mm of height from the lower line, the mesial line is flushed with the anterior wall and the distal line will correspond to the position of the most distal implant. The final product was fabricated using OnDemand3D™ which was then transferred to the 3d printer machine.

Patients were instructed to rinse with 0.125% chlorhexidine antiseptic mouth-wash for 2 minutes prior to surgery. The surgical area was anesthetized with local anesthesia. Infraorbital and greater palatine nerve blocks and local infiltration were given in order to properly anesthetize the area. A crestal incision was made in the posterior edentulous area followed by a vertical incision made at 45 degrees distal to the most anterior tooth. A full thickness mucoperiosteal flap was elevated at the surgical site enabling the apical osteotomy line to be drawn at a distance of 6mm above the residual bone height from the ridge. The customized surgical guide was secured in its proper position. After drilling, the anchor pin was placed in the prepared place. Using the standardized piezoelectric tip (SL1) with sterile saline irrigation, the outline of the window in the lateral maxillary sinus wall was formed.

The bone window was thinned down using the specialized DASK drill #4 and #5 from the DASK Kit until the grey shadow of the sinus membrane becomes visible. The sinus membrane at the circumference of the bony window was detached using the dome-shaped Sinus Membrane Elevator (XSE1L). Sinus membrane elevators (XSE2L), (XSE3L) and (XSE4L) were used to carefully lift the sinus membrane from the floor and anterior wall of the sinus to create adequate space for graft material (Figure 2-b). The membrane was further elevated to the medial wall in order to provide additional blood supply from that bone. The implants were drilled in the positions indicated by the surgical guide. Half the amount of the xenograft was introduced into the cavity followed by insertion of the dental implants. The dental implants were placed at torque 30~45N‧cm. Stability of the implants was measured using an implant stability meter.

Filling the cavity with the rest of the xenograft was completed after implant placement(s). The size of the collagen membrane was adjusted to match the size of the lateral bone window and then placed and stabilized by the cover screw. The flap was released by short horizontal cuts in the inner surface of the mucosa to provide a tension free flap. This was followed by closure of the flap with water tight sutures (horizontal mattress with a single interrupted it's centre) using 3/0 silk suture material.

After 6 months from the operation, a small incision was made directly over the implant and the cover screw was removed. Implant stability was measured again using the Osstell device. The abutment was placed at torque 25~30 N.cm. An impression was taken and sent to the lab for fixed prosthetics construction. The fixed prosthesis was cemented using glass ionomer cement.

Being tested
Low Window Sinus Lift technique
Keywords
sinus augmentation

What participants receive

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

  • Low Window Sinus Lift techniqueProcedure or surgery

    Preoperative CBCT of surgical site and Fabrication CAD/CAM surgical stent, Sinus elevation using "Low Window Sinus Lift" technique, Implant, bone graft and membrane placement

Study groups in NCT04618588
Study groupRoleWhat they receive
Sinus elevation using "Low Window Sinus Lift" techniqueExperimentalNot described
Receives: Procedure: Low Window Sinus Lift technique

What is being measured

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

  1. Presence or absence of intra or postoperative complications

    • Schneiderian membrane perforation occurrence is noted intraoperatively
    • Intra/post operative bleeding, postoperative sinusitis, periimplantitis

    Measured: 6 months

  2. Postoperative pain

    This was assessed using a 10-point Visual Analogue Scale (VAS) in the 1st week postoperatively.

    (0-1=None, 2-4=Mild-Moderate, 8-10= Severe)

    Measured: 1 week

Secondary outcomes (5)

  1. Implant stability

    Implant stability is measured using the Osstell device immediately following implant placement and 6 months postoperatively (prior to abutment loading).

    Measured: 6 months

  2. Postoperative edema

    This was assessed in the 1st week postoperatively and measured as follows:

    • None (no inflammation)
    • Mild (intraoral swelling confined to the surgical field)
    • Moderate (extraoral swelling in the surgical zone)
    • Severe (extraoral swelling spreading beyond the surgical zone)+

    Measured: 1 week

  3. Bone Density

    Radiographic evaluation of bone density around each implant was done using OnDemand3D™ program.

    Measurements were taken as follows:

    1. From the tool bar, the bone density around the implant was selected from task section.
    2. The required area was selected and bone density was chosen. Mean, standard deviation, minimum and maximum readings were automatically displayed by the system.

    Measured: 6 months

  4. Vertical bone height gained

    4 reference points are selected on the CBCT. A vertical line immediately adjacent to the implant threads perpendicular to the horizontal line is drawn to a point on the bony floor of the maxillary sinus. From the cross-sectional view of 6 months postoperative, the distance from the crestal bone at the implant platform and the bone apical to the implant apex. The measurements are then subtracted from the preoperative bone height to obtain the amount of vertical bone height gained.

    Measured: 6 months

  5. Marginal bone loss

    Marginal bone loss (MBL) were measured at the buccal and palatal aspects of each implant using the implant/abutment junction as a reference point to the most coronal bone-implant junction. Measurements were performed on the CBCT immediately after surgery (baseline) and 6 months postoperatively.

    A decrease in this vertical distance between the reference point and the most coronal bone-implant contact on consecutive radiographs indicated a marginal bone loss (MBL).

    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 posted6 Nov 2020
  2. Study start1 Jan 2019
  3. Primary completion17 Dec 2019
  4. Study completion17 Dec 2019

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04618588
Sponsor's protocol ID
Sinus lift
Status last verified
Nov 2020
First submitted
1 Nov 2020
Last updated
6 Nov 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Aghaloo TL, Misch C, Lin GH, Iacono VJ, Wang HL. Bone Augmentation of the Edentulous Maxilla for Implant Placement: A Systematic Review. Int J Oral Maxillofac Implants. 2016;31 Suppl:s19-30. doi: 10.11607/jomi.16suppl.g1.

    PubMed 27228250

  • Antonaya-Mira R, Barona-Dorado C, Martinez-Rodriguez N, Caceres-Madrono E, Martinez-Gonzalez JM. Meta-analysis of the increase in height in maxillary sinus elevations with osteotome. Med Oral Patol Oral Cir Bucal. 2012 Jan 1;17(1):e146-52. doi: 10.4317/medoral.16921.

    PubMed 22157659

  • Antonoglou GN, Stavropoulos A, Samara MD, Ioannidis A, Benic GI, Papageorgiou SN, Sandor GK. Clinical Performance of Dental Implants Following Sinus Floor Augmentation: A Systematic Review and Meta-Analysis of Clinical Trials with at Least 3 Years of Follow-up. Int J Oral Maxillofac Implants. 2018 May/Jun;33(3):e45-e65. doi: 10.11607/jomi.6417.

    PubMed 29763503

  • Bornstein MM, Cionca N, Mombelli A. Systemic conditions and treatments as risks for implant therapy. Int J Oral Maxillofac Implants. 2009;24 Suppl:12-27.

    PubMed 19885432

  • Boyne PJ, James RA. Grafting of the maxillary sinus floor with autogenous marrow and bone. J Oral Surg. 1980 Aug;38(8):613-6. No abstract available.

    PubMed 6993637

  • Cavalcanti MC, Guirado TE, Sapata VM, Costa C, Pannuti CM, Jung RE, Cesar Neto JB. Maxillary sinus floor pneumatization and alveolar ridge resorption after tooth loss: a cross-sectional study. Braz Oral Res. 2018 Aug 6;32:e64. doi: 10.1590/1807-3107BOR-2018.vol32.0064.

    PubMed 30088551

  • Cosci F, Luccioli M. A new sinus lift technique in conjunction with placement of 265 implants: a 6-year retrospective study. Implant Dent. 2000;9(4):363-8. doi: 10.1097/00008505-200009040-00014.

    PubMed 11307560

  • Danesh-Sani SA, Loomer PM, Wallace SS. A comprehensive clinical review of maxillary sinus floor elevation: anatomy, techniques, biomaterials and complications. Br J Oral Maxillofac Surg. 2016 Sep;54(7):724-30. doi: 10.1016/j.bjoms.2016.05.008. Epub 2016 May 25.

    PubMed 27235382

  • Dula K, Mini R, van der Stelt PF, Buser D. The radiographic assessment of implant patients: decision-making criteria. Int J Oral Maxillofac Implants. 2001 Jan-Feb;16(1):80-9.

    PubMed 11280366

  • Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.

    PubMed 17695343

  • Fugazzotto PA. The modified trephine/osteotome sinus augmentation technique: technical considerations and discussion of indications. Implant Dent. 2001;10(4):259-64. doi: 10.1097/00008505-200110000-00009.

    PubMed 11813667

  • Hwang D, Wang HL. Medical contraindications to implant therapy: Part II: Relative contraindications. Implant Dent. 2007 Mar;16(1):13-23. doi: 10.1097/ID.0b013e31803276c8.

    PubMed 17356368

  • Jivraj S, Chee W. Treatment planning of implants in posterior quadrants. Br Dent J. 2006 Jul 8;201(1):13-23. doi: 10.1038/sj.bdj.4813766.

    PubMed 16829878

  • Johnson C. Measuring Pain. Visual Analog Scale Versus Numeric Pain Scale: What is the Difference? J Chiropr Med. 2005 Winter;4(1):43-4. doi: 10.1016/S0899-3467(07)60112-8.

    PubMed 19674646

  • Liddelow G, Klineberg I. Patient-related risk factors for implant therapy. A critique of pertinent literature. Aust Dent J. 2011 Dec;56(4):417-26; quiz 441. doi: 10.1111/j.1834-7819.2011.01367.x.

    PubMed 22126353

Questions about this trial

What is this clinical trial studying?

A study testing Low Window Sinus Lift technique in people with Sinus Perforation, run by Hams Hamed Abdelrahman 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 5 inclusion and 8 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 6 Nov 2020. 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?

Presence or absence of intra or postoperative complications (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04618588, which also lists 35 linked publications.

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 6 Nov 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in