NCT03855852

Brief Summary

Comparative study for evaluation of vertical bone gain after one stage ridge augmentation with advanced platelet rich fibrin (A-PRF) and xenograft versus guided bone regeneration using collagen membrane and xenograft.

Trial Health

43
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 Feb 2019

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

February 1, 2019

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

February 25, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 27, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

May 16, 2019

Status Verified

May 1, 2019

Enrollment Period

1.1 years

First QC Date

February 25, 2019

Last Update Submit

May 15, 2019

Conditions

Bone Loss, Alveolar

Keywords

vertical bone defectRidge augmentationOne stageXenograftCollagen membraneAdvanced platelet rich fibrinGuided bone regenerationSurgical templateImplanthorizontal bone defect

Outcome Measures

Primary Outcomes (1)

  • vertical buccal bone gain

    It will be measured using UNC Periodontal probe

    6 months

Secondary Outcomes (3)

  • horizontal bone gain

    6 months

  • Ridge width

    6 months

  • Post-surgical patient satisfaction

    9 months

Study Arms (2)

Xenograft and Collagen membrane

ACTIVE COMPARATOR

Placing the implant with collagen membrane and xenograft at esthetic zone of maxillary ridge when 2-4 mm of implant threads exposure .

Procedure: Xenograft and Collagen membrane

Xenograft and A-PRF

EXPERIMENTAL

Placing the implant with xenograft and A-PRF at esthetic zone of maxillary ridge when 2-4 mm of implant threads exposure .

Procedure: Xenograft and APRF

Interventions

Xenograft and Collagen membranePROCEDURE

Placing the implant with collagen membrane and xenograft at esthetic zone of maxillary ridge with 2-4 mm thread exposure .

Xenograft and Collagen membrane
Xenograft and APRFPROCEDURE

Placing the implant with APRF and xenograft at esthetic zone of maxillary ridge with 2-4 mm thread exposure .

Xenograft and A-PRF

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 18 years old.
  • Systemically healthy.
  • Has good dental health.
  • Missing a single tooth in the maxillary anterior and premolar region
  • Crestal residual ridge width of 4-5mm.
  • Residual ridge with an adequate band of keratinized tissue (2 mm).
  • Residual ridge with sufficient vertical bone height to safely place a \>10 mm long dental implant.

You may not qualify if:

  • Severe parafunctional habits, for example, bruxing and clenching.
  • Conditions that complicate wound healing, for example, uncontrolled diabetes (defined as HBA1c level \>7%) or smoking.
  • Conditions that might lead to a possibly lowered regenerative capacity of the bone, for example, osteoporosis and Paget's disease.
  • Pregnant or expecting to be pregnant.
  • History of drug and alcohol abuse or certain medications like bisphosphonates or steroids currently or within the past three months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry , Cairo University

Giza, 12613, Egypt

RECRUITING

MeSH Terms

Conditions

Alveolar Bone Loss

Interventions

Transplantation, Heterologous

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

TransplantationSurgical Procedures, Operative

Study Officials

  • Abdallah M Shbair, B.D.S

    Dr

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdallah W Shabir, B.D.S

CONTACT

01281855966abdallah.w.shbair@outlook.com

Manal M Hosny, Professor

CONTACT

01118459362manhosny@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment * A Randomized clinical trial * Parallel study group * A trial will be carried out in outpatient clinic of Periodontology Department ,Faculty of Dentistry , Cairo University . * Equal randomization with equal probabilities for intervention. * Positive controlled : Both groups will receive treatment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

February 25, 2019

First Posted

February 27, 2019

Study Start

February 1, 2019

Primary Completion

March 1, 2020

Study Completion

June 1, 2020

Last Updated

May 16, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)