Osseodensification Versus Osteotome Internal Sinus Lifting in Delayed Implant Placement

Not Applicable

Recruiting

• Conditions: Maxillary Sinus Floor Augmentation
• Interventions: Procedure: Osseodensification Internal Sinus Lift; Procedure: Osteotome Internal Sinus Lift

• Registration Number: NCT05495490
• Lead Sponsor: Ain Shams University

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.

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.

Study Timeline

• Study First Submitted: 2022-08-05
• Study First Submitted QC: 2022-08-08
• Study First Posted: 2022-08-10
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-29
• Study Start: 2025-02-10
• Primary Completion: 2026-01
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Osseodensification Internal Sinus Lift / Sticky Bone graft material	Osseodensification Internal Sinus Lift	Osseodensification Internal Sinus Lift will be performed using sticky bone as a graft material.
Osteotome Internal Sinus Lift /Sticky Bone graft material	Osteotome Internal Sinus Lift	Osteotome Internal Sinus Lift will be performed using sticky bone as a graft material.

Primary Outcome Measures

Name	Time	Method
Radiographic Assessment of Change in the Vertical Bone Height (Bone Gain).	Pre-operative and Immediately post-operative.	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.
Radiographic Assessment of Change in the Bone Density.	Pre-operative and Immediately post-operative.	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.

Secondary Outcome Measures

Name	Time	Method
Patient's Post-Operative Pain Assessment	1 week post-operative	The outcome will be obtained by the aid of a 100 mm Visual Analogue Scale (0 = minimal to; 100 = maximum)
Operator's Satisfaction Assessment	1 year	The outcome will be obtained by the aid of a a questionnaire assessing the operator's satisfaction with Osseodensification and Osteotome sinus lift techniques.
Clinical Assessment of Primary Stability of the Implants (Implant Stability Quotient ) Measured by an Osstell® Device.	During procedure.	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) .
Clinical Assessment of Primary Stability of the Implants ( Insertion Torque Value) Measured by a Torque Wrench.	During procedure.	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).
Patient's Satisfaction Assessment.	1 week post-operative	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.

Trial Locations

Locations (2)

Faculty of Dentistry- Assiut University; 🇪🇬 Assiut, Egypt

Faculty of Dentistry- Ain Shams University; 🇪🇬 Cairo, Egypt