Osseodensifiction Versus Piezoelectric Internal Sinus Elevation Technique in Delayed Implant Placement

Maxillary Sinus Floor Augmentation Clinical Trial

Official title:

Osseodensifiction Versus Piezoelectric Internal Sinus Elevation (PISE) Technique in Delayed Implant Placement (A Randomized Controlled Clinical Trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06055127
• Other study ID #: FDASU_Rec IM 122215
• Status: Recruiting
• Phase: N/A
• Start date: September 8, 2023
• Est. completion date: September 2024

Study information

• Verified date: September 2023
• Source: Ain Shams University
• Contact: Mohammed Samir, BDs
• Phone: 01144063175
• Email: Mohammedsamir495[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The present study is a parallel single-blinded randomized controlled clinical trial.

The study will be conducted after being reviewed and approved by the Faculty of Dentistry, AinShams University Research Ethics Committee (FDASU-REC).

The study population will be randomly allocated into two groups of the same size:

Group 1: Osseodensifiction sinus lift will be performed using sticky bone as a graft material.

Group 2: Piezoelectric Internal Sinus Elevation (PISE) will be performed using sticky bone as a graft material.

The aim of the present study is to evaluate the effectiveness and clinical results of osseodensification in comparison to Piezoelectric Internal Sinus Elevation (PISE) Technique in Delayed Implant Placement.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

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 ?-?).

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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Maxillary Sinus Floor Augmentation

Intervention

Procedure:
• osseodensifiction internal sinus lift / sticky bone graft material
The osteotomy for the osseodensification internal sinus lift begins with a twist drill advanced at 800 rpm with saline irrigation to within 1-2 mm from the sinus floor. Next, a series of osteotomy drills are used in the same fashion at 800 rpm to widen the osteotomy. The final osteotomy drill is advanced with gentle pressure at 100 rpm counterclockwise without irrigation until a bouncing sensation occurs "haptic feedback" at this point infracture of the sinus has taken place. After infracture, injection of the graft material into the osteotomy site will occur. The final osteotomy drill is used to guide the graft apically. This process is repeated in an incremental fashion to lift the membrane. Once enough space has been created below the antral membrane, implant insertion will occur then suturing.
• piezoelectric internal sinus lift / sticky bone graft material
In the PISE technique, an ultrasonic piezoelectric device (acteon), to which a specialized tip is attached, is used to break the sinus floor. Developed for sinus lift by the crestal approach, the Intralift™ Kit makes it possible to undertake dental non invasive surgery in full safety. The diamond-coated tips, of increasing diameters (from 1.35mm to 2.80mm), are designed to drill and gradually widen the access canal to the sinus membrane. The sterile spray cools the tips down to avoid any rise in temperature, which could lead to oral tissue damage.The membrane elevation is achieved using the TKW5 by means of microcavitation. Thanks to the ultrasonic frequency modulation, the risk of membrane damage is limited. Moreover, the cavitation effect enables excellent visibility of the operating field.

Locations

Country	Name	City	State
Egypt	AinShams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

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. — View Citation

Li J, Lee K, Chen H, Ou G. Piezoelectric surgery in maxillary sinus floor elevation with hydraulic pressure for xenograft and simultaneous implant placement. J Prosthet Dent. 2013 Nov;110(5):344-8. doi: 10.1016/j.prosdent.2013.04.002. Epub 2013 Sep 29. — View Citation

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. — View Citation

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

Torrella F, Pitarch J, Cabanes G, Anitua E. Ultrasonic ostectomy for the surgical approach of the maxillary sinus: a technical note. Int J Oral Maxillofac Implants. 1998 Sep-Oct;13(5):697-700. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographic assessment of change in the vertical bone height (bone gain)	Immediate postoperative CBCTs will be taken to all participants to assess bone gain .	per-operative and immediately post-operative
Primary	Radiographic assessment of bone density	Immediate postoperative CBCTs will be taken to all participants to assess bone density.	per-operative and immediately post-operative
Secondary	implant primary stability (insertion torque )	implant insertion torque will be assessed using torque wrench .	during procedure
Secondary	implant primary stability (ISQ)	implant stability quotient will be assessed using Osstell device	during procedure
Secondary	patient post-operative pain assessment	obtained using a 100 mm visual analogue scale	1 week post-operative
Secondary	patient's satisfaction assessment	obtained by the aid of a health-related quality of life questionnaire	1 week post-operative
Secondary	operator's satisfaction assessment	obtained by the aid of a questionnaire assessing the operator's satisfaction	1 year