Osseodensifiction Versus Piezoelectric Internal Sinus Elevation Technique in Delayed Implant Placement

Not Applicable

Completed

• Conditions: Maxillary Sinus Floor Augmentation
• Interventions: Procedure: osseodensifiction internal sinus lift / sticky bone graft material; Procedure: piezoelectric internal sinus lift / sticky bone graft material

• Registration Number: NCT06055127
• Lead Sponsor: Ain Shams University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-08
• Study First Submitted: 2023-09-16
• Study First Submitted QC: 2023-09-24
• Study First Posted: 2023-09-26
• Primary Completion: 2024-01-30
• Study Completion: 2024-05-31
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

  2. Medical conditions affecting bone metabolism and ongoing treatment with bisphosphonates drugs or systemic steroids.

  3. Presence of acute or chronic sinus pathoses or sinus membrane perforation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
osseodensifiction internal sinus lift / sticky bone graft material	osseodensifiction internal sinus lift / sticky bone graft material	Osseodensifiction compacts bone and simultaneously autografts it into the osteotomy walls and apex instead of removing it. The use of a Densah® drill bit at high speed counterclockwise, without a cutting edge and with a steady irrigation causes the formation of a layer of strong dense bone along the walls of the base of the osteotomy preparation.
piezoelectric internal sinus lift / sticky bone graft material	piezoelectric internal sinus lift / sticky bone graft material	The piezoelectric surgical sets comprise various inserts from osteotomies to diamond-cutting inserts. The hydropneumatics pressure of the saline solution irrigation is subjected to the piezoelectric cavitation pushing the Schneiderian membrane upwards resulting in its' detachment and floating

Primary Outcome Measures

Name	Time	Method
Radiographic assessment of change in the vertical bone height (bone gain)	per-operative and immediately post-operative	Immediate postoperative CBCTs will be taken to all participants to assess bone gain .
Radiographic assessment of bone density	per-operative and immediately post-operative	Immediate postoperative CBCTs will be taken to all participants to assess bone density.

Secondary Outcome Measures

Name	Time	Method
implant primary stability (ISQ)	during procedure	implant stability quotient will be assessed using Osstell device
patient post-operative pain assessment	1 week post-operative	obtained using a 100 mm visual analogue scale
operator's satisfaction assessment	1 year	obtained by the aid of a questionnaire assessing the operator's satisfaction
implant primary stability (insertion torque )	during procedure	implant insertion torque will be assessed using torque wrench .
patient's satisfaction assessment	1 week post-operative	obtained by the aid of a health-related quality of life questionnaire

Trial Locations

Locations (1)

AinShams University; 🇪🇬 Cairo, Egypt