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Maxillary Sinus Floor AugmentationNCT05495490

Osseodensification Versus Osteotome Internal Sinus Lifting in Delayed Implant Placement

A study testing Osseodensification Internal Sinus Lift and Osteotome Internal Sinus Lift in people with Maxillary Sinus Floor Augmentation, run by Ain Shams University at 2 sites in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The sinus lift technique through alveolar crest Osseodensification is conservative, minimally invasive, and minimally traumatic, utilizing hydropneumatic counterclockwise rotating instruments to lift the maxillary sinus floor without touching the Schneiderian membrane, thereby minimizing the risk of perforation. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Maxillary Sinus Floor Augmentation
What is being tested?
Osseodensification Internal Sinus Lift and Osteotome Internal Sinus Lift
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesEgypt
Study dates
10 Feb 2026to 21 Apr 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 1. Patient partially edentulous with maxillary posterior edentulous ridge after extraction of more than 4 months.
  • 2. Both sexes will be selected males and females.
  • 3. Adult patients aged between 18 and 40 years of age.
  • 4. Good general health (American Society of Anesthesiology Physical Status Ⅰ-Ⅱ).
  • 5. Initial residual alveolar ridge height ranging between 4 to 6 mm according to preoperative CBCT.
  • 6. No previous surgery or radiation treatment on the maxillary sinus.

Who cannot join

  • 1. Smokers.
  • 2. Pregnant or lactating females.
  • 3. Psychiatric disorders.
  • 4. Uncontrolled systemic disease.
  • 5. Hematologic diseases and coagulation disorders.
  • 6. Chemotherapy or radiotherapy of the head and neck area, and immunocompromised status.
  • 7. Medical conditions affecting bone metabolism and ongoing treatment with bisphosphonates drugs or systemic steroids.
  • 8. Presence of acute or chronic sinus pathoses or sinus membrane perforation.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Omneya M. Elkadi, Ass.Lecturer contact

00201121844448

ninielkadi@gmail.com

Egypt2 sites, 2 recruiting
  • Faculty of Dentistry- Assiut University

    Asyut, 71517

    Omneya M. Elkadi, Ass.Lecturer, 00201121844448, ninielkadi@gmail.com

    Recruiting
  • Faculty of Dentistry- Ain Shams University

    Cairo, 11566

    Omneya M. Elkadi, Ass.Lecturer, 00201121844448, ninielkadi@gmail.com

    Recruiting

Other trials in Egypt

About this study

Official title: Osseodensification Versus Osteotome Internal Sinus Lifting in Delayed Implant Placement (A Randomized Controlled Clinical Trial)

The sinus lift technique through alveolar crest Osseodensification is conservative, minimally invasive, and minimally traumatic, utilizing hydropneumatic counterclockwise rotating instruments to lift the maxillary sinus floor without touching the Schneiderian membrane, thereby minimizing the risk of perforation. In contrast, the internal sinus lift technique utilizing osteotomes to raise the Schneiderian membrane eliminated hammering, making the technique more patient-friendly, with the placement of a graft biomaterial around the implant. The challenge in this technique was the availability of > 5mm residual bone height preventing membrane perforation and low primary implant stability. Consequently, the investigator aims to compare the efficacy and clinical outcomes of Osseodensification and Osteotome internal sinus lifting after delayed implant placement by assessing bone gain and bone density around implants radiographically, the primary stability of the implants clinically, and patient satisfaction.

Read the detailed description

Twenty patients with maxillary posterior edentulous ridge will be randomly assigned to one of two equal groups: Osseodensification sinus lift using sticky bone as a graft material (Group 1) and Osteotome internal sinus lift using sticky bone as a graft material (Group 2). (Group 2). Using Cone Beam Computed Tomography (CBCT), the sinus anatomy and height and width of the residual ridge from the sinus floor to the alveolar crest of all patients will be evaluated prior to surgery. Each patient will then receive pre-surgical medication consisting of intravenous steroidal anti-inflammatory drug (dexamethasone sodium phosphate 4mg) one hour prior to the procedure and oral rinsing with 0.12 percent chlorhexidine for one minute. After surgery, patients will receive 14 days of twice-daily chlorhexidine rinses 0.12 percent for postoperative treatment. Patients allergic to penicillin are given 1 g amoxicillin twice daily for six days or 0.5 g azithromycin. Ibuprofen (400) should be administered three times daily unless medically contraindicated. After insertion, the primary stability of each implant will be evaluated using a torque wrench and an Osstell device. All patients will undergo immediate postoperative CBCTs to assess bone gain and bone density. Utilizing the Visual Analogue Scale, patients' pain will be evaluated (VAS). A health-related quality of life questionnaire will be used to evaluate the patients' perception of recovery in terms of pain, oral function, general activity, and other symptoms. Postoperatively, the operator's subjective satisfaction with Osseodensification and Osteotome sinus lift techniques will be evaluated using a second printed questionnaire.

Being tested
Osseodensification Internal Sinus Lift, Osteotome Internal Sinus Lift
Keywords
Osseodensification, Osteotome, Internal Sinus Lifting, Sticky Bone

What participants receive

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

  • Osseodensification Internal Sinus LiftProcedure or surgery

    The osteotomy for the Osseodensification internal sinus lift begins with the advancement of a twist drill at 800 rpm and saline irrigation to within 1-2 mm of the sinus floor. The osteotomy is then widened by employing a series of osteotomy drills rotating at 800 rpm. Infracture of the sinus has occurred when the final osteotomy drill is advanced with gentle pressure at 100 rpm counterclockwise without irrigation until a bouncing sensation ("haptic feedback") occurs. After infracture, the graft material will be injected into the osteotomy site. Using the final osteotomy drill, the graft is guided apically. This procedure is repeated incrementally to raise the membrane. Once sufficient space has been created beneath the antral membrane, the implant will be inserted followed by suturing.

  • Osteotome Internal Sinus LiftProcedure or surgery

    Also called Bone-Added Osteotome Sinus Floor Elevation Technique, Summers Osteotome Technique

    The osteotomy for the Osteotome internal sinus lift will begin with standard drills and saline irrigation to prepare the implant socket with a working length that is 1-2 mm shorter than the residual bone height as determined by radiographic examination. After preparation, a series of osteotomes of varying diameters will be sequentially utilized to widen the osteotomy and elevate the Schneiderian membrane by vertical tapping to create a "greenstick" fracture. The Valsalva maneuver (nasal blowing test) will be performed to determine the integrity of the Schneiderian membrane. During the osteotomy, the graft material will be injected and slowly placed into the elevated space using osteotomes until the desired depth is reached. Implant placement and suturing will conclude the procedure.

Study groups in NCT05495490
Study groupRoleWhat they receive
Osseodensification Internal Sinus Lift / Sticky Bone graft materialExperimentalOsseodensification Internal Sinus Lift will be performed using sticky bone as a graft material.
Receives: Procedure: Osseodensification Internal Sinus Lift
Osteotome Internal Sinus Lift /Sticky Bone graft materialActive comparatorOsteotome Internal Sinus Lift will be performed using sticky bone as a graft material.
Receives: Procedure: Osteotome Internal Sinus Lift

What is being measured

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

  1. Radiographic Assessment of Change in the Vertical Bone Height (Bone Gain).

    The outcome will be obtained by the aid of Computed Cone Beam Tomography, assessing the amount of change from the pre-operative to the post-operative vertical bone height in millimeters.

    Measured: Pre-operative and Immediately post-operative.

  2. Radiographic Assessment of Change in the Bone Density.

    The outcome will be obtained by the aid of Computed Cone Beam Tomography assessing the amount of change from the pre-operative to the post-operative bone density values in Hounsfield unit.

    Measured: Pre-operative and Immediately post-operative.

Secondary outcomes (5)
  1. Clinical Assessment of Primary Stability of the Implants ( Insertion Torque Value) Measured by a Torque Wrench.

    The outcome will be obtained by the aid of a torque wrench and recorded in Newton centimeters.

    ( low torque (<30), medium torque (30 < Insertion Torque < 50), and high torque (>50).

    Measured: During procedure.

  2. Clinical Assessment of Primary Stability of the Implants (Implant Stability Quotient ) Measured by an Osstell® Device.

    The outcome will be obtained by the aid of an Osstell device, measured by the Resonance Frequency Analysis and determined by the Implant Stability Quotient ( within a 0-100 scale; 100 being maximum implant stability) .

    Measured: During procedure.

  3. Patient's Post-Operative Pain Assessment

    The outcome will be obtained by the aid of a 100 mm Visual Analogue Scale (0 = minimal to; 100 = maximum)

    Measured: 1 week post-operative

  4. Patient's Satisfaction Assessment.

    The outcome will be obtained by the aid of a health-related quality of life questionnaire designed to assess the patient's perception of recovery concerning pain, oral function, general activity, and other symptoms.

    Measured: 1 week post-operative

  5. Operator's Satisfaction Assessment

    The outcome will be obtained by the aid of a a questionnaire assessing the operator's satisfaction with Osseodensification and Osteotome sinus lift techniques.

    Measured: 1 year

Timeline

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

  1. First posted10 Aug 2022
  2. Study start10 Feb 2026 (estimated)
  3. Primary completion21 Mar 2027 (estimated)
  4. Study completion21 Apr 2027 (estimated)

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
Model description
Parallel single-blind masking randomized controlled clinical trial
Masking
Single blind
Who is masked
Participant
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05495490
Sponsor's protocol ID
FDASU-Rec ID032230
Other IDs
1120
Status last verified
Jan 2026
First submitted
5 Aug 2022
Last updated
21 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie the results reported in this article after deidentification. (Text, tables, figures and appendices).

Publications

  • Huwais S, Mazor Z, Ioannou AL, Gluckman H, Neiva R. A Multicenter Retrospective Clinical Study with Up-to-5-Year Follow-up Utilizing a Method that Enhances Bone Density and Allows for Transcrestal Sinus Augmentation Through Compaction Grafting. Int J Oral Maxillofac Implants. 2018 Nov/Dec;33(6):1305-1311. doi: 10.11607/jomi.6770.

    PubMed 30427961
  • Pjetursson BE, Lang NP. Sinus floor elevation utilizing the transalveolar approach. Periodontol 2000. 2014 Oct;66(1):59-71. doi: 10.1111/prd.12043.

    PubMed 25123761
  • 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
  • Mourao CF, Valiense H, Melo ER, Mourao NB, Maia MD. Obtention of injectable platelets rich-fibrin (i-PRF) and its polymerization with bone graft: technical note. Rev Col Bras Cir. 2015 Nov-Dec;42(6):421-3. doi: 10.1590/0100-69912015006013. English, Portuguese.

    PubMed 26814997
  • Gheno E, Alves GG, Ghiretti R, Mello-Machado RC, Signore A, Lourenco ES, Leite PEC, Mourao CFAB, Sohn DS, Calasans-Maia MD. "Sticky Bone" Preparation Device: A Pilot Study on the Release of Cytokines and Growth Factors. Materials (Basel). 2022 Feb 16;15(4):1474. doi: 10.3390/ma15041474.

    PubMed 35208017
  • Zhou X, Hu XL, Li JH, Lin Y. Minimally Invasive Crestal Sinus Lift Technique and Simultaneous Implant Placement. Chin J Dent Res. 2017;20(4):211-218. doi: 10.3290/j.cjdr.a39220.

    PubMed 29181458
  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Osseodensification Internal Sinus Lift and Osteotome Internal Sinus Lift in people with Maxillary Sinus Floor Augmentation, run by Ain Shams University at 2 sites 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 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: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Omneya M. Elkadi, Ass.Lecturer (00201121844448, ninielkadi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Radiographic Assessment of Change in the Vertical Bone Height (Bone Gain). (time frame: Pre-operative and Immediately post-operative.). 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 NCT05495490, which also lists 7 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 21 Jan 2026.

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