Closed Sinus Tenting Using Densah Burs Osteotomy Versus Conventional Osteotomy in Localized Pneumatization

Not Applicable

• Conditions: Edentulous Alveolar Ridge
• Interventions: Procedure: Use of Densah Burs in closed sinus lift; Procedure: Closed sinus lift using osteotomes

• Registration Number: NCT05513170
• Lead Sponsor: Cairo University

Brief Summary

Isolated sinus pneumatization after single tooth extraction indicate sinus lifting for proper implant placement. The conventional way of using osteotomes to elevate the sinus is annoying to patient and also does not give the needed amount of bone around the implant. Introducing new intervention of Densah Burs helps increase bone gain around implant and decrease the patient discomfort.

Detailed Description

The rehabilitation of the edentulous posterior maxilla using osseointegrated implants is often challenging due alveolar bone resorption, low bone density and maxillary sinus pneumatization. Maxillary sinus lift is one of the most common surgical techniques used for increasing the available bone volume to place implants and restore function and esthetics. Trans-crestal approach can be successfully adopted when residual bone height is at least 5 mm. Osteotome sinus floor elevation was first in 1994, and proved to be less invasive, more conservative, less time consuming, and reduces postoperative discomfort to the patient. Moreover, this technique was found to yield predictable results with success rates of at least 95%.

Osseodensification is a new surgical technique of biomechanical bone preparation performed for dental implant placement where bone is compacted and auto grafted into open marrow spaces and osteotomy site walls in outwardly expanding directions. It was reported that osseodensification increases the bone-implant contact, bone density, and primary stability. Moreover, the insertion torque peak is directly related to implant primary stability and host bone density. Furthermore, for every 9.8 N cm of torque increased, a reduction in failure rate of 20% in single-tooth implant restoration was observed.

The objective of this study is to evaluate crestal sinus elevation using osseodensification versus osteotomy clinically and radiographically in terms of marginal bone loss, primary and secondary stability and bone gain around the implant.

Study Timeline

• Study First Submitted: 2022-06-27
• Status Verified: 2022-08
• Study First Submitted QC: 2022-08-20
• Last Update Submitted: 2022-08-20
• Study First Posted: 2022-08-24
• Last Update Posted: 2022-08-24
• Study Start: 2022-09-01
• Primary Completion: 2023-10-01
• Study Completion: 2023-11-01

Recruitment & Eligibility

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

Inclusion Criteria

• No inflamed sinus
• Minimum alveolar ridge height 5-6 mm
• Medical free
• Both genders males and females.

Exclusion Criteria

• Remaining alveolar ridge height is less than 5mm

• Patients should not have taken drugs, especially bisphosphonates or drugs altering bone metabolism, within 2 months before the inclusion in the study.

  • Subjected to irradiation in the head and neck area less than 1 year before implantation.
  • Patients having history of allergy to any drugs.
  • Patients who have a history of any concomitant from a major known medical problem and/or ongoing pharmacologic treatments
  • Untreated periodontitis.
  • Poor oral hygiene and motivation.
  • Uncontrolled diabetes.
  • Pregnant or nursing.
  • Substance abuse.
  • Psychiatric problems or unrealistic expectations.
  • Severe bruxism or clenching.
  • Immunosuppressed or immunocompromised.
  • Treated or under treatment with intravenous amino-bisphosphonates.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional closed sinus lift using osteotomes	Use of Densah Burs in closed sinus lift	Sinus lifting will be performed using osteotomes and then dental implants will be placed.
Closed sinus lift using Densah bur	Closed sinus lift using osteotomes	Closed sinus lifting will be performed using densah burs and then dental implants will be placed.

Primary Outcome Measures

Name	Time	Method
Measurement of Bone Change in Cone Beam CT	three and six months	The amount of bone change will be determined by superimposing pre-operative CBCT (cone-beam computed tomography), three months post-operative, and six months post-operative CBCT.

Secondary Outcome Measures

Name	Time	Method
Measurement of Primary and Secondary Implant stability using Resonance Frequency Analysis (RFA)	At the day of implant placement and after six months	The implant stability quotient (ISQ) of the implants will be measured using a resonance frequency analysis measuring device, that is, Ostell, at the time of placement, which is the primary stability, and after six months, which is the secondary stability. The implant stability quotient has a scale ranging from 0 to 100 in which 0 is a failed implant and 100 is maximum implant stability.