Tenting Abutment Technique Versus Screw"Tent-Pole" Technique for Augmentation of Posterior Atrophic Mandible
A Comparative Study Between Tenting Abutment Technique Versus Screw"Tent-Pole" Technique for Augmentation of Posterior Atrophic Mandible Randomized Clinical Trial
1 other identifier
interventional
16
1 country
1
Brief Summary
To evaluate a novel method using a designed tenting abutment to reduce number of surgeries and the edentulous healing period is shortened. In addition, to prevent vertical and horizontal collapse of the bone graft and minimizes resorption of the bone graft during the healing the atrophic posterior mandible. The tent pole provides excellent mechanical properties; stability \& fixation, yet very poor features to preserve the integrity of the soft tissue. Using the tenting abutment technique will help preserve the soft tissue and decrease the amount of dehiscence that might accompany the use of the tent pole.
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
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
May 30, 2024
CompletedFirst Posted
Study publicly available on registry
June 5, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2024
CompletedJune 5, 2024
June 1, 2023
9 months
May 30, 2024
May 30, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
height gained and width gained
height gained and width gained Measure unit milimerter (mm) Measure device :CBCT
before and post operative four months
Secondary Outcomes (1)
Soft tissue dehiscence
after one month
Study Arms (2)
conventional group
ACTIVE COMPARATORUsing a tent pole to gain bone in the atrophic posterior mandible.
study group
ACTIVE COMPARATORUsing a Tenting abutment to gain bone in the atrophic posterior mandible
Interventions
To evaluate a novel method using a designed tenting abutment to reduce number of surgeries and the edentulous healing period is shortened. In addition, to prevent vertical and horizontal collapse of the bone graft and minimizes resorption of the bone graft during the healing the atrophic posterior mandible.
using the Tent pole technique to gain bone vertical and horizontal loss
Eligibility Criteria
You may qualify if:
- Patients with atrophic posterior mandible.
- Both sexes.
- No intraoral soft and hard tissue pathology.
- No systemic condition that contraindicates implant placement
You may not qualify if:
- Local criteria:
- Untreated gingivitis, periodontitis.
- Insufficient oral hygiene.
- Previous radiation therapy for the head and neck neoplasia, or bone augmentation to implant site..
- Systemic criteria:
- Systemic disorders.
- Heavy smoking of more than 20 cigarettes per day.
- Bone pathology.
- ·Psychiatric problems. Emotional instability. Unrealistic aesthetic demands.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Alaa Mohammed Hafedh
Cairo, Egypt
Study Officials
- STUDY DIRECTOR
Mohamed ahmed Farid shehab, professor
supervisor
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PRINCIPLE INVESTIGATOR
Study Record Dates
First Submitted
May 30, 2024
First Posted
June 5, 2024
Study Start
October 1, 2023
Primary Completion
July 1, 2024
Study Completion
October 1, 2024
Last Updated
June 5, 2024
Record last verified: 2023-06