Osseodensification Versus Osteotome Internal Sinus Lifting in Delayed Implant Placement

NCT05495490 | Recruiting DMC

• 2 other identifiers: FDASU-Rec ID0322301120
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Maxillary Sinus Floor Augmentation

Keywords

Osseodensification; Osteotome; Internal Sinus Lifting; Sticky Bone

Outcome Measures

Primary Outcomes (2)

• 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.

  Pre-operative and Immediately post-operative.

• 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.

  Pre-operative and Immediately post-operative.

Secondary Outcomes (5)

• Clinical Assessment of Primary Stability of the Implants ( Insertion Torque Value) Measured by a Torque Wrench.

  During procedure.

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

  During procedure.

• Patient's Post-Operative Pain Assessment

  1 week post-operative

• Patient's Satisfaction Assessment.

  1 week post-operative

• Operator's Satisfaction Assessment

  1 year

Study Arms (2)

Osseodensification Internal Sinus Lift / Sticky Bone graft material

EXPERIMENTAL

Osseodensification Internal Sinus Lift will be performed using sticky bone as a graft material.

Procedure: Osseodensification Internal Sinus Lift

Osteotome Internal Sinus Lift /Sticky Bone graft material

ACTIVE COMPARATOR

Osteotome Internal Sinus Lift will be performed using sticky bone as a graft material.

Procedure: Osteotome Internal Sinus Lift

Interventions

Osseodensification Internal Sinus Lift PROCEDURE

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.

Osseodensification Internal Sinus Lift / Sticky Bone graft material

Osteotome Internal Sinus Lift PROCEDURE

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.

Also known as: Bone-Added Osteotome Sinus Floor Elevation Technique, Summers Osteotome Technique

Osteotome Internal Sinus Lift /Sticky Bone graft material

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (2)

Faculty of Dentistry- Assiut University

Asyut, 71517, Egypt

RECRUITING

Faculty of Dentistry- Ain Shams University

Cairo, 11566, Egypt

RECRUITING

Related Publications (7)

• 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.

  PMID: 30427961 BACKGROUND

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

  PMID: 25123761 BACKGROUND

• 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.

  PMID: 27235382 BACKGROUND

• 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.

  PMID: 26814997 BACKGROUND

• 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.

  PMID: 35208017 BACKGROUND

• 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.

  PMID: 29181458 BACKGROUND

• 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.

  PMID: 17695343 BACKGROUND

Study Officials

• Hala A. Abuel- Ela, Professor

  Faculty of Dentistry- Ain Shams University

  STUDY DIRECTOR

• Mohamed W. Bissar, Lecturer

  Faculty of Dentistry- Ain Shams University

  STUDY DIRECTOR

• Omneya M. Elkadi

  Faculty of Dentistry- Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Omneya M. Elkadi, Ass.Lecturer

CONTACT

00201121844448; ninielkadi@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Computer-generated randomization table
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Model Details: Parallel single-blind masking randomized controlled clinical trial

Study Record Dates

• First Submitted: August 5, 2022
• First Posted: August 10, 2022
• Study Start: February 10, 2026
• Primary Completion (Estimated): March 21, 2027
• Study Completion (Estimated): April 21, 2027
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary identified for this purpose")

Locations

EG (2)