Autogenous Bone Mixed With Xenograft Versus Xenograft Alone Versus Absorbent Gelatin Sponge
Alveolar Ridge Preservation in Mandibular Molars Using Mixture of Autogenous Bone & Anorganic Bovine Bone (ABB) Versus Anorganic Bovine Bone Alone Versus Absorbent Gelatin Sponge
1 other identifier
interventional
30
0 countries
N/A
Brief Summary
Alveolar bone atrophy post-extraction has been well documented in the past years. normal healing event results in a minimal loss of vertical height (around 1 mm), but a substantial loss of width in the buccal-lingual plane (4-6 mm). Alveolar socket preservation is thought to deal with this issue as to prevent the loss of alveolar bone dimensions post extraction in the case of delayed 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 Aug 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
June 29, 2018
CompletedFirst Posted
Study publicly available on registry
July 12, 2018
CompletedStudy Start
First participant enrolled
August 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2019
CompletedJuly 17, 2018
July 1, 2018
5 months
June 29, 2018
July 13, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Histomorphometrical bone analysis
histological bone core analysis
6 month post primary surgery
Secondary Outcomes (1)
Alveolar Bone marginal loss
6 month post primary surgery
Study Arms (3)
Mixture of Autogenous bone & Anorganic Bovine Bone (ABB)
EXPERIMENTALsocket preservation with a mixture of autogenous bone graft acquired at the time of extraction mixed with a 50:50 ratio of Anorganic bovine bone
Anorganic bovine bone graft (ABB)
ACTIVE COMPARATORfilling the extraction socket with ABB graft
Absorbable gelatin Sponge
ACTIVE COMPARATORFilling the socket with an absorbable gelatin sponge
Interventions
Filling the socket with Mixing of autogenous bone graft and anorganic bovine bone in a 50:50 ratio
Filling the socket with Anorganic bovine bone graft material only
Filling the socket with an absorbable gelatin sponge foam pack
Eligibility Criteria
You may qualify if:
- Adult patients with hopeless mandibular molars indicated for extraction and implant placement in two stages that indicate socket preservation.
- Both sexes.
- No intraoral soft and hard tissue pathology.
- No systemic condition that contraindicate implant placement.
You may not qualify if:
- Presence of fenestrations or dehiscence of the residual bony Walls after extraction.
- Heavy smokers more than 20 cigarettes per day .(24)
- Patients with systemic disease that may affect normal healing.
- Psychiatric problems
- Disorders to implant are related to a history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.
- Patients that refuse to be called back for implant placement post extraction.
- Patients that have exceeded bone resorption surrounding the tooth prior to extraction and require guided bone regeneration.
- Pregnant Females.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 29, 2018
First Posted
July 12, 2018
Study Start
August 1, 2018
Primary Completion
January 1, 2019
Study Completion
July 1, 2019
Last Updated
July 17, 2018
Record last verified: 2018-07