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

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ClinicalTrials.gov Identifier: NCT03584984
Recruitment Status : Not yet recruiting
First Posted : July 12, 2018
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
Dina Mohammed Al-esawy, Cairo University

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

Condition or disease Intervention/treatment Phase
Bone Resorption Alveolar Bone Loss Alveolar Bone Resorption Bone Graft Failure Procedure: Mixture of Autogenous bone & Anorganic Bovine Bone (ABB) Procedure: Anorganic Bovine Bone (ABB) Procedure: Absorbable gelatin sponge Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Alveolar Ridge Preservation in Mandibular Molars Using Mixture of Autogenous Bone & Anorganic Bovine Bone (ABB) Versus Anorganic Bovine Bone Alone Versus Absorbent Gelatin Sponge
Estimated Study Start Date : August 1, 2018
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Gelatin

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




Primary Outcome Measures :
  1. Histomorphometrical bone analysis [ Time Frame: 6 month post primary surgery ]
    histological bone core analysis


Secondary Outcome Measures :
  1. Alveolar Bone marginal loss [ Time Frame: 6 month post primary surgery ]
    CBCT measurements of marginal bone dimensional difference



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03584984


Contacts
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Contact: Dina M. Al-Esawy, Masters 01206036365 dr.dina.alesawy@hotmail.com
Contact: Dina M. Al-Esawy, Masters 01206036565 dr.dina.alesawy@hotmail.com

Sponsors and Collaborators
Cairo University

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Responsible Party: Dina Mohammed Al-esawy, Principal Investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03584984     History of Changes
Other Study ID Numbers: 2807
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Bone Resorption
Alveolar Bone Loss
Bone Diseases
Musculoskeletal Diseases
Periodontal Atrophy
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Gelatin Sponge, Absorbable
Hemostatics
Coagulants