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

July 13, 2018 updated by: Dina Mohammed Al-esawy, Cairo University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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
Procedure: 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
ACTIVE_COMPARATOR: Anorganic bovine bone graft (ABB)
filling the extraction socket with ABB graft
Procedure: Anorganic Bovine Bone (ABB)
Filling the socket with Anorganic bovine bone graft material only
ACTIVE_COMPARATOR: Absorbable gelatin Sponge
Filling the socket with an absorbable gelatin sponge
Procedure: Absorbable gelatin sponge
Filling the socket with an absorbable gelatin sponge foam pack

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Histomorphometrical bone analysis
Time Frame: 6 month post primary surgery
histological bone core analysis
6 month post primary surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alveolar Bone marginal loss
Time Frame: 6 month post primary surgery
CBCT measurements of marginal bone dimensional difference
6 month post primary surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

August 1, 2018

Primary Completion (ANTICIPATED)

January 1, 2019

Study Completion (ANTICIPATED)

July 1, 2019

Study Registration Dates

First Submitted

June 29, 2018

First Submitted That Met QC Criteria

July 11, 2018

First Posted (ACTUAL)

July 12, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 17, 2018

Last Update Submitted That Met QC Criteria

July 13, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2807

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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