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

Cairo University (CU) logo

Cairo University (CU)

Status

Not yet enrolling

Conditions

Edentulous Alveolar Ridge

Treatments

Procedure: Closed sinus lift using osteotomes
Procedure: Use of Densah Burs in closed sinus lift

Study type

Interventional

Funder types

Other

Identifiers

NCT05513170
Densah Burs

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

20 participants in 2 patient groups

Closed sinus lift using Densah bur
Active Comparator group
Description:
Closed sinus lifting will be performed using densah burs and then dental implants will be placed.
Treatment:
Procedure: Closed sinus lift using osteotomes
Conventional closed sinus lift using osteotomes
Active Comparator group
Description:
Sinus lifting will be performed using osteotomes and then dental implants will be placed.
Treatment:
Procedure: Use of Densah Burs in closed sinus lift

Trial documents
3

Trial contacts and locations

0

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Central trial contact

Eman M Anwar, Professor

Data sourced from clinicaltrials.gov

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