Osseodensification by Densah Burs Versus Osteotome
1 other identifier
interventional
12
1 country
1
Brief Summary
implant placement in the posterior maxilla is problematic, not only due to inferior properties of bone but also due to loss of vertical bone height which happens after extraction of posterior teeth. when the required additional height is few millimeters, indirect transcresta sinus lifting procedures are recommended. This study compares sinus lifting using the conventional osteotome versus the osseodensification with densah burs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 12, 2020
CompletedFirst Submitted
Initial submission to the registry
December 18, 2020
CompletedFirst Posted
Study publicly available on registry
December 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2021
CompletedDecember 30, 2020
December 1, 2020
7 months
December 18, 2020
December 26, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
implant stability
Using the Osstell, The result is presented as an ISQ value of 1-100. The higher the ISQ, the more stable the implant
at 6 months
change in bone height
using CBCT
at baseline and 6 months
change in bone density
using CBCT
at baseline and 6 months
Secondary Outcomes (2)
Pain scores
at 2 weeks
edema scores
at 2 weeks
Study Arms (2)
osteotome sinus lifting
ACTIVE COMPARATORoseodensification sinus lifting
EXPERIMENTALInterventions
application of first densah bur with densifying mood (reverse) counterclockwise, 1200 revolution per minute until the sinus is reached then use a wider densah bur with the same mode and bouncing motion to elevate the sinus floor up to 3 mm in 1mm increments.
drilling implant site with consecutive drills short of the sinus floor by 1-2mm , using osteotome in appropriate size and application of one tap until sinus floor is elevated, using the final drill for the desired implant diameter
Eligibility Criteria
You may qualify if:
- Patient with missing maxillary premolas and molars
- Vertical bone height of 5-8 mm
- Non smokers
- Good oral hygiene
You may not qualify if:
- Bad oral hygiene
- maxillary sinusitis
- Presence of infection or periapical lesions in adjacent teeth
- Bruxism or clenching
- Alcoholism
- Medically compromised patients with a condition that affect the procedure
- Multiple sinus septa
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University
Alexandria, Egypt
Related Publications (1)
Elghobashy MTM, Shaaban AM, Melek LNF. Radiographic comparison between Densah burs and osteotome for graftless internal sinus lifting with simultaneous implant placement: a randomized clinical trial. Int J Oral Maxillofac Surg. 2023 Mar;52(3):388-395. doi: 10.1016/j.ijom.2022.06.020. Epub 2022 Jul 13.
PMID: 35840446DERIVED
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant lecturer of DPH and Clinical statistician
Study Record Dates
First Submitted
December 18, 2020
First Posted
December 30, 2020
Study Start
December 12, 2020
Primary Completion
July 1, 2021
Study Completion
August 1, 2021
Last Updated
December 30, 2020
Record last verified: 2020-12