NCT03584997

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)

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 12, 2018

Completed
20 days until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

July 17, 2018

Status Verified

July 1, 2018

Enrollment Period

4 months

First QC Date

June 29, 2018

Last Update Submit

July 13, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • histomorphometrical bone quality

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

    6 month

Secondary Outcomes (1)

  • marginal bone loss

    6 month

Study Arms (2)

PRF , ABB & Autogenous Particulate

EXPERIMENTAL

Platelets rich fibrin + anorganic bovine bone + autogenous particulate graft

Procedure: PRF, ABB & Autogenous Particulate

ABB And Autogenous Particulate

ACTIVE COMPARATOR

anorganic bovine bone +autogenous particulate graft

Procedure: ABB And Autogenous Particulate

Interventions

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

ABB And Autogenous Particulate

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

PRF , ABB & Autogenous Particulate

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Alveolar Bone Loss

Interventions

Prolactin-Releasing Hormone

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Hypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Central Study Contacts

Mohammed D Darwish, Masters

CONTACT

Mohammed D Darwish, Masters

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 29, 2018

First Posted

July 12, 2018

Study Start

August 1, 2018

Primary Completion

December 1, 2018

Study Completion

July 1, 2019

Last Updated

July 17, 2018

Record last verified: 2018-07