Autogenous Bone Mixed With Xenograft Versus Xenograft Alone Versus Absorbent Gelatin Sponge

NCT03584984 — Not applicable, Unknown, 30 participants, Cairo University

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Alveolar Ridge Preservation in Mandibular Molars Using Mixture of Autogenous Bone & Anorganic Bovine Bone (ABB) Versus Anorganic Bovine Bone Alone Versus Absorbent Gelatin Sponge

Registry	NCT03584984
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	30 (Estimated)
Sponsor	Cairo University (Other)
Conditions	Bone Resorption, Alveolar Bone Loss, Alveolar Bone Resorption, Bone Graft Failure
Interventions	Mixture of Autogenous bone & Anorganic Bovine Bone (ABB), Anorganic Bovine Bone (ABB), Absorbable gelatin sponge (Procedure)
Dates	start 2018-08-01 (estimated), primary completion 2019-01-01 (estimated), completion 2019-07-01 (estimated), first posted 2018-07-12, last updated 2018-07-17

-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

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+Arms and interventions

Arm	Type	Interventions	Description
Mixture of Autogenous bone & Anorganic Bovine Bone (ABB)	Experimental	Procedure: Mixture of Autogenous bone & Anorganic Bovine Bone (ABB)	socket 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 comparator	Procedure: Anorganic Bovine Bone (ABB)	filling the extraction socket with ABB graft
Absorbable gelatin Sponge	Active comparator	Procedure: Absorbable gelatin sponge	Filling the socket with an absorbable gelatin sponge

Mixture of Autogenous bone & Anorganic Bovine Bone (ABB) (Procedure): Filling the socket with Mixing of autogenous bone graft and anorganic bovine bone in a 50:50 ratio
Anorganic Bovine Bone (ABB) (Procedure): Filling the socket with Anorganic bovine bone graft material only
Absorbable gelatin sponge (Procedure): Filling the socket with an absorbable gelatin sponge foam pack

+Outcome measures

Primary outcomes

Histomorphometrical bone analysis [6 month post primary surgery]: histological bone core analysis

Secondary outcomes

Alveolar Bone marginal loss [6 month post primary surgery]: CBCT measurements of marginal bone dimensional difference

+Eligibility

Sex: All, ages: 18 Years to 50 Years, accepts healthy volunteers

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.