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

NCT ID: NCT03584984

Last Updated: 2018-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2019-07-01

Brief Summary

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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

Detailed Description

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Conditions

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Bone Resorption Alveolar Bone Loss Alveolar Bone Resorption Bone Graft Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Mixture of Autogenous bone & Anorganic Bovine Bone (ABB)

Intervention Type PROCEDURE

Filling the socket with Mixing of autogenous bone graft and anorganic bovine bone in a 50:50 ratio

Anorganic bovine bone graft (ABB)

filling the extraction socket with ABB graft

Group Type ACTIVE_COMPARATOR

Anorganic Bovine Bone (ABB)

Intervention Type PROCEDURE

Filling the socket with Anorganic bovine bone graft material only

Absorbable gelatin Sponge

Filling the socket with an absorbable gelatin sponge

Group Type ACTIVE_COMPARATOR

Absorbable gelatin sponge

Intervention Type PROCEDURE

Filling the socket with an absorbable gelatin sponge foam pack

Interventions

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Mixture of Autogenous bone & Anorganic Bovine Bone (ABB)

Filling the socket with Mixing of autogenous bone graft and anorganic bovine bone in a 50:50 ratio

Intervention Type PROCEDURE

Anorganic Bovine Bone (ABB)

Filling the socket with Anorganic bovine bone graft material only

Intervention Type PROCEDURE

Absorbable gelatin sponge

Filling the socket with an absorbable gelatin sponge foam pack

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Dina Mohammed Al-esawy

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Dina M. Al-Esawy, Masters

Role: CONTACT

01206036365

Dina M. Al-Esawy, Masters

Role: CONTACT

01206036565

Other Identifiers

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2807

Identifier Type: -

Identifier Source: org_study_id

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