Evaluation of Osseodensification Versus Osseodensification With Ridge Splitting in Horizontally Deficient Ridge
1 other identifier
interventional
16
0 countries
N/A
Brief Summary
Osseodensification is a method of biomechanical bone preparation where specially designed burs increase density of bone as they expand an osteotomy. These osseodensifying burs combine advantages of osteotome bone preservation with the standard traditional drilling burs speed and tactile control. The investigators compared ridge splitting followed by osseodensification versus osseodensification in terms of buccolingual ridge expansion both clinically and radiographically.
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 Oct 2022
Typical duration for not_applicable
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
First Submitted
Initial submission to the registry
September 29, 2022
CompletedStudy Start
First participant enrolled
October 1, 2022
CompletedFirst Posted
Study publicly available on registry
October 6, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2025
CompletedOctober 6, 2022
October 1, 2022
2.3 years
September 29, 2022
October 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
assessment of gain in alveolar ridge width
Radiographically
before surgery and immediately after surgery
Secondary Outcomes (2)
primary implant stability
at the end of surgery
bone density
before surgery and immediately after surgery
Study Arms (2)
Osseodensification with ridge splitting
EXPERIMENTALRidge splitting followed by osseodensification using osseodensifying burs .
Osseodensification
ACTIVE COMPARATORosseodensification will be performed using osseodensifying burs.
Interventions
Ridge splitting followed by ossedensificaion with osseodensifying burs.
Pilot drill is used to make the initial osteotomy to the desired depth, then osseodensifying burs will be used in sequence, gradually wider diameter in a counterclockwise rotation and bouncing motion under profuse saline irrigation
Eligibility Criteria
You may qualify if:
- Patients suffering from missing single or multiple maxillay anterior and /or premolar with at least 8 mm alveolar ridge height, with 4-6mm alveolar buccolingual (BL) ridge width.
- Patients should be systemically healthy.
- Patients available during follow up periods.
You may not qualify if:
- Pregnant females.
- Smokers.
- Poor oral hygiene.
- Vulnerable patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Officials
- STUDY DIRECTOR
Nevine H. El Din, Professor
Faculty of Dentistry, Ain Shams University
Central Study Contacts
Yasmine E. Fouad, Lecturer
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant lecturer of periodontology
Study Record Dates
First Submitted
September 29, 2022
First Posted
October 6, 2022
Study Start
October 1, 2022
Primary Completion
January 1, 2025
Study Completion
January 1, 2025
Last Updated
October 6, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share