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Status unknownNCT05513170Updated Aug 24, 2022

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

An interventional study of Use of Densah Burs in closed sinus lift and Closed sinus lift using osteotomes in Edentulous Alveolar Ridge, sponsored by Cairo University. Status unknown. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-24.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Edentulous Alveolar Ridge

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Keywords

  • Densah Burs
  • Osteotomes
  • Sinus Tenting
  • Graftless
03

In context

Mouth, Edentulous

244 studies on the registry are indexed under Mouth, Edentulous; 37 are open to participants now.

This study's planned enrollment of 20 is below the median of 30 across 187 interventional studies indexed under Mouth, Edentulous.

Browse Mouth, Edentulous studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
20 participants (estimated)

Study arms

  • Active comparator
    Closed sinus lift using Densah bur

    Closed sinus lifting will be performed using densah burs and then dental implants will be placed.

    Procedure: Closed sinus lift using osteotomes

  • Active comparator
    Conventional closed sinus lift using osteotomes

    Sinus lifting will be performed using osteotomes and then dental implants will be placed.

    Procedure: Use of Densah Burs in closed sinus lift

Interventions

  • ProcedureUse of Densah Burs in closed sinus lift

    Closed sinus will be performed using Densah Burs. Densah Burs enhance bone quality through osseodensification; a process through which bone is compacted and auto-graphted in the marrow spaces and apically to elevate the sinus floor and enhance bone density.

  • ProcedureClosed sinus lift using osteotomes

    Closed sinus lift will be performed using osteotomes. Osteotomes elevate the sinus floor and enhance the bone quality.

06

What researchers measure

Primary outcomes

  1. Measurement of Bone Change in Cone Beam CT

    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.

    Time frame: three and six months

Secondary outcomes

  1. Measurement of Primary and Secondary Implant stability using Resonance Frequency Analysis (RFA)

    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.

    Time frame: At the day of implant placement and after six months

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Ottoni JM, Oliveira ZF, Mansini R, Cabral AM. Correlation between placement torque and survival of single-tooth implants. Int J Oral Maxillofac Implants. 2005 Sep-Oct;20(5):769-76. PubMed 16274152 ↗
  • Summers RB. A new concept in maxillary implant surgery: the osteotome technique. Compendium. 1994 Feb;15(2):152, 154-6, 158 passim; quiz 162. PubMed 8055503 ↗

Study documents

  • Study protocol · Oct 26, 2021
  • Statistical analysis plan · Oct 26, 2021
  • Informed consent form · Oct 26, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05513170
Lead sponsor
Cairo University
Responsible party
Basma Mohamed Abdelfatah Mohamed Shaheen (Doctor of Dental Surgery, Cairo University) — Principal investigator
First posted
Aug 24, 2022
Start date
Sep 1, 2022 (estimated)
Primary completion
Oct 1, 2023 (estimated)
Completion
Nov 1, 2023 (estimated)
Last update
Aug 24, 2022

Study contacts

Eman M Anwar, Professor
Contact
rec@dentistry.cu.edu.eg
+20223642705 ext. 522

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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