Clinical trial NCT06055127: Osseodensifiction Versus Piezoelectric Internal Sinus Elevation Technique in Delayed Implant Placement
Official title: Osseodensifiction Versus Piezoelectric Internal Sinus Elevation (PISE) Technique in Delayed Implant Placement (A Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maxillary Sinus Floor Augmentation
Keywords: internal sinus elevation
osseodensfication,
piezoelectric surgery
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-09-26
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel single blind masking randomized controlled clinical trail
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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 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.

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.

Primary outcomes:
measure: Radiographic assessment of change in the vertical bone height (bone gain)
timeFrame: per-operative and immediately post-operative
measure: Radiographic assessment of bone density
timeFrame: per-operative and immediately post-operative
Secondary outcomes:
measure: implant primary stability (insertion torque )
timeFrame: during procedure
measure: implant primary stability (ISQ)
timeFrame: during procedure
measure: patient post-operative pain assessment
timeFrame: 1 week post-operative
measure: patient's satisfaction assessment
timeFrame: 1 week post-operative
measure: operator's satisfaction assessment
timeFrame: 1 year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: AinShams University
Study officials:
affiliation: AinShams University
name: Mohammed Samir, BDs
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.
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.