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Ridge Preservation In Mandibular Molars Using Mixture Of ABB And Autogenous Particulate VS Sticky Bone

Primary Purpose

Alveolar Bone Loss, Bone Graft Failure, Alveolar Bone Resorption

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

ABB And Autogenous Particulate

PRF, ABB & Autogenous Particulate

About this trial

This is an interventional treatment trial for Alveolar Bone Loss

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts 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 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PRF , ABB & Autogenous Particulate

ABB And Autogenous Particulate

Arm Description

Platelets rich fibrin + anorganic bovine bone + autogenous particulate graft

anorganic bovine bone +autogenous particulate graft

Outcomes

Primary Outcome Measures

histomorphometrical bone quality

histological bone quality measured from a core sample taken from the grafted site

Secondary Outcome Measures

marginal bone loss

alveolar margin bone loss measured be CBCT

Full Information

NCT ID

NCT03584997

First Posted

June 29, 2018

Last Updated

July 13, 2018

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT03584997

Brief Title

Ridge Preservation In Mandibular Molars Using Mixture Of ABB And Autogenous Particulate VS Sticky Bone

Official Title

Alveolar Ridge Preservation In Mandibular Molars Using Mixture Of Anorganic Bovine Bone(ABB) And Autogenous Particulate VS Mixture Of Injectable Platelets Rich Fibrin, ABB And Autogenous Particulates (Sticky Bone).

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Unknown status

Study Start Date

August 1, 2018 (Anticipated)

Primary Completion Date

December 1, 2018 (Anticipated)

Study Completion Date

July 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Histological Measurement Comparing the density of the new bone formed during socket preservation technique using a Mixture of Anorganic Bovine Bone(ABB) And Autogenous Particulate vs a Mixture of Injectable Platelets Rich Fibers, ABB And Autogenous Particulates (sticky bone). radiographical measurements of the amount of bone dimensions changes in socket preservation technique in 6-month period using a Mixture Of Anorganic Bovine Bone(ABB) And Autogenous Particulate vs a Mixture Of Injectable Platelets Rich Fibers, ABB And Autogenous Particulates (sticky bone)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alveolar Bone Loss, Bone Graft Failure, Alveolar Bone Resorption

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PRF , ABB & Autogenous Particulate

Arm Type

Experimental

Arm Description

Platelets rich fibrin + anorganic bovine bone + autogenous particulate graft

Arm Title

ABB And Autogenous Particulate

Arm Type

Active Comparator

Arm Description

anorganic bovine bone +autogenous particulate graft

Intervention Type

Procedure

Intervention Name(s)

ABB And Autogenous Particulate

Intervention Description

Mixing the autogenous bone graft aquired at the time of surgery with a 50:50 ration of anorganic bovine bone and filling the socket

Intervention Type

Procedure

Intervention Name(s)

PRF, ABB & Autogenous Particulate

Intervention Description

adding an injectable platelets rich fibrin to a Mixture of autogenous bone graft aquired at the time of surgery with a 50:50 ration of anorganic bovine bone and filling the socket

Primary Outcome Measure Information:

Title

histomorphometrical bone quality

Description

histological bone quality measured from a core sample taken from the grafted site

Time Frame

6 month

Secondary Outcome Measure Information:

Title

marginal bone loss

Description

alveolar margin bone loss measured be CBCT

Time Frame

6 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mohammed D Darwish, Masters

Phone

00201206036565

doctorelsayed87@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Mohammed D Darwish, Masters

Phone

00201206036365

doctorelsayed87@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Ridge Preservation In Mandibular Molars Using Mixture Of ABB And Autogenous Particulate VS Sticky Bone

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