Comparative Study Between Autogenous Bone Block and Tent Pole Technique for Augmentation of Atrophic Anterior Maxilla
1 other identifier
interventional
24
1 country
1
Brief Summary
The goal of this clinical trial is to compare in patients with atrophied anterior maxilla, bone augmentation techniques ( gold standard bone block and tent pole technique). The main question it aims to answer is : Does screw tent pole technique provides better bone gain than autogenous bone block in atrophied anterior maxilla?
- primary objective to assess amount of bone gain
- secondary objective assess bone quality Participants will be randomly divided into two groups study group ( tent pole technique) and control group ( bone block) - each group will be followed up monthly for soft tissue dehiscence and after 6 month to assess bone gain and bone quality and then implant placement.
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 2023
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
October 1, 2023
CompletedFirst Submitted
Initial submission to the registry
October 27, 2023
CompletedFirst Posted
Study publicly available on registry
November 9, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2024
CompletedNovember 9, 2023
November 1, 2023
6 months
October 27, 2023
November 5, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bone Gain
to assess amount of bone gain before and after 6 month of the surgical procedure
6 month
Secondary Outcomes (1)
Bone quality evaluation
6 month post-operative
Other Outcomes (1)
soft tissue dehiscence
monthly for 6 months post-operative
Study Arms (2)
tent pole technique
EXPERIMENTALThe screw tent-pole method is an effective technique to achieve initial reconstruction of alveolar bone deficiencies
autogenous bone block technique
ACTIVE COMPARATORBone block graft has been the gold standard for restoring deficient regions.
Interventions
The screw tent-pole method is an effective technique to achieve initial reconstruction of alveolar bone deficiencies
Bone block graft has been the gold standard for restoring deficient regions.
Eligibility Criteria
You may qualify if:
- systemically healthy patients (American Society of Anesthesiologists -ASA I and II); older than 18 years
- Patients with atrophic anterior maxilla ,with initial ridge wi¬dth of ≤ 5 mm and moderate bone height as diagnosed at the time of digital implant planning
- No intraoral soft and hard tissue pathology.
- Cone Beam Computer Tomography scan before and after bone augmentation.
- Apprehensive to be in the study
You may not qualify if:
- Bad oral hygiene.
- smokers (\>10 cigarettes/day);
- Existence of a bone metabolic disease; currently taking drugs that might influence bone metabolism
- Radiotherapy or chemotherapy for malignancy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Cairo University
Cairo, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Youmna M Abdelhady
Cairo University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- master candidate
Study Record Dates
First Submitted
October 27, 2023
First Posted
November 9, 2023
Study Start
October 1, 2023
Primary Completion
April 1, 2024
Study Completion
July 1, 2024
Last Updated
November 9, 2023
Record last verified: 2023-11