Assessment of Implants Placed in Consolidated Graft With Different Bone Drills.
ASSESSMENT OF DENTAL IMPLANTS PLACED IN MANDIBULAR CONSOLIDATED ILIAC-CREST BONE GRAFTS USING DENSAH BURS VERSUS THE STANDARD DRILLS (A Randomized Controlled Trial)
1 other identifier
interventional
12
1 country
1
Brief Summary
The anterior iliac crest is a popular source of bone harvest. However, when fused to the intramembranous jaw bones, it yields low-density bones that qualitatively and quantitatively endanger the fixture's stability. In 1994, Summers first documented using the bone-condensing approach to improve the primary stability of dental implants. This study aims to determine whether osseodensifying the consolidated mandibular bone grafts will improve implant stability and marginal bone loss
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 Jun 2024
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
June 9, 2024
CompletedFirst Submitted
Initial submission to the registry
June 21, 2024
CompletedFirst Posted
Study publicly available on registry
June 27, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2025
CompletedJune 27, 2024
June 1, 2024
10 months
June 21, 2024
June 26, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Radiographic bone loss
Calibration of the amplitude of vertical bone loss
6 months osseointegration period
Secondary Outcomes (1)
Implant stability
6 months osseointegration period
Study Arms (2)
Test group
ACTIVE COMPARATORThe dental implants placed after bone osseodensification using densah burs
Control group
ACTIVE COMPARATORThe dental implants placed after conventional bone drilling with the standard drills
Interventions
implants placed in consolidated bone grafts
Eligibility Criteria
You may qualify if:
- Patients of both sexes with an age range of 18-55 years.
- Patients subjected to a successful iliac crest mandibular bone graft after segmental mandibular resection.
- A minimal ridge height of ten millimeters and a ridge width of seven millimeters.
- Healthy soft tissue coverage, with a reasonable interaction space.
You may not qualify if:
- Clinical or radiographic signs of graft infection, rejection, or massive resorption.
- The previous exposure to radiotherapy or chemotherapy.
- Any systemic disease that would affect bone healing or implant osseointegration.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Oral and Maxillofacial Surgery, Faculty of Oral and Dental Medicine, Modern University for Technology & Information.
Cairo, Egypt
Central Study Contacts
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
- Associate Professor of Oral and Maxillofacial Surgery
Study Record Dates
First Submitted
June 21, 2024
First Posted
June 27, 2024
Study Start
June 9, 2024
Primary Completion
April 1, 2025
Study Completion
April 1, 2025
Last Updated
June 27, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share