Assessment of Collagen Plug for Alveolar Socket Sealing With Simultaneous Implant Placement in Maxillary Esthetic Zone
Assessment of Collagen Plug Versus Free Gingival Graft for Alveolar Socket Sealing With Simultaneous Implant Placement in Maxillary Esthetic Zone
1 other identifier
interventional
20
0 countries
N/A
Brief Summary
Following tooth extraction alveolar ridge will undergo dimensional changes and soft tissue may collapse. These changes may complicate the subsequent restorative procedure especially in the esthetic zone. It was observed that socket-healing process may be divided into three sequential, and frequently over-lapping phases: inflammatory, proliferative and modeling/remodeling. Implants placed in fresh extraction sockets alone wasn't found to prevent the resorption of the alveolar 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 Oct 2018
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 16, 2018
CompletedFirst Posted
Study publicly available on registry
October 5, 2018
CompletedStudy Start
First participant enrolled
October 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedOctober 5, 2018
October 1, 2018
8 months
September 16, 2018
October 3, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
changes in soft tissue
soft tissue changes will be measured in millimeters clinically and on a cast before and after the procedure
3 month
changes in bone
bone loss and gain will be measured in millimeters using cone beam computed tomography before and after the procedure
6 month
Study Arms (1)
collagen plug
EXPERIMENTALcollagen plug used to seal the socket after atraumatic extraction of the badly deacayed teeth with immediate implant placement and bone graft
Interventions
Use of free gingival graft to seal the socket after flapless atraumatic tooth extraction is performed, implant placement and filling the socket with bone graft.
Eligibility Criteria
You may qualify if:
- Patients with maxillary teeth in the esthetic zone (incisors/premolars) requiring extractions.
- Both sexes.
- No intraoral soft and hard tissue pathology.
- No systemic condition that contraindicate implant placement.
You may not qualify if:
- Uncontrolled periapical infections
- Heavy smokers more than 20 cigarettes per day.
- Patients with systemic disease that may affect normal healing.
- Psychiatric problems
- Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site
- Immunodeficiency pathology, bruxism, stress situation (socially or professionally), emotional instability, and unrealistic aesthetic demands.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
September 16, 2018
First Posted
October 5, 2018
Study Start
October 20, 2018
Primary Completion
July 1, 2019
Study Completion
September 1, 2019
Last Updated
October 5, 2018
Record last verified: 2018-10