Immediate Implant Placement With Platlet Rich Fibrin as Space Filling Material Versus the Use of Deprotienized Bovine Bone (Tutogen) in Maxillary Premolars.
1 other identifier
interventional
20
0 countries
N/A
Brief Summary
20 subjects suffering from non restorable maxillary premolar teeth will be randomly devided into two groups. the selected teeth will be extracted and immeiate implants will be placed in all subjects. the first group will recieve deprotienized bovine bone (tutogen) to fill the buccal space between the implant and the bone, the second group will recieve platlet rich fibrin to fill the buccal space between the implant and the bone
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 Jul 2016
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
July 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedFirst Submitted
Initial submission to the registry
June 6, 2017
CompletedFirst Posted
Study publicly available on registry
June 12, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedJune 14, 2017
June 1, 2017
11 months
June 6, 2017
June 10, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Patient morbidity
patient pain level on pain scale using pain chart
14 days
Secondary Outcomes (2)
crestal bone loss
3 months
implants stability quotient
3 months
Study Arms (2)
platelet rich fibrin
EXPERIMENTALimmediate implant grafting
deprotienized bovine bone (tutogen)
ACTIVE COMPARATORimmediate implant grafting
Interventions
Eligibility Criteria
You may qualify if:
- non restorable maxillary premolars non smoker free from any systemic disease or medication that could impair normal bone healing
You may not qualify if:
- any systemic disease that could affect bone healing patient with lesion related to the surgical site
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
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
- Principal Investigator
Study Record Dates
First Submitted
June 6, 2017
First Posted
June 12, 2017
Study Start
July 1, 2016
Primary Completion
June 1, 2017
Study Completion
July 1, 2017
Last Updated
June 14, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will share