NCT04775940

Brief Summary

Comparing amount of horizontal bone gain 4 months after alveolar ridge augmentation using IPRF Nano- micro Sticky Bone with perforated collagen membrane versus occlusive barrier membrane by :

  1. 1.clinical and Radiographic analysis .
  2. 2.Histomorphometric analysis .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 1, 2021

Completed
Last Updated

March 1, 2021

Status Verified

February 1, 2021

Enrollment Period

6 months

First QC Date

February 26, 2021

Last Update Submit

February 26, 2021

Conditions

Bone Augmentation

Outcome Measures

Primary Outcomes (1)

  • Horizontal alveolar bone width in mm

    Measured By Bone caliber and Cone Beam Computed Tomography (CBCT)

    6 months

Study Arms (2)

Perforated collagen membrane

EXPERIMENTAL
Procedure: Perforated collagen membrane

Occlusive collagen membrane

ACTIVE COMPARATOR
Procedure: Occlusive collagen membrane

Interventions

Perforated collagen membranePROCEDURE

Horizontal Bone Augmentation using Perforated Collagen Membrane

Perforated collagen membrane
Occlusive collagen membranePROCEDURE

Occlusive collagen membrane

Occlusive collagen membrane

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adult patients.
  • Both sex, males and females. 3-Age from 20 - 40 years old. 4-All patients will be free from any systemic diseases as evidenced by Burkett's oral medicine health history questionnaire.
  • Remaining alveolar bone ≥ 8mm vertically and ≤ 4 mm horizontally. 6-Gingival biotype 1-2mm thickness.

You may not qualify if:

  • Smokers.
  • Pregnant and breast feeding females.
  • Mentally retarded Patients.
  • Presence of hematologic disease.
  • Previous radiation, chemotherapy, or immunosuppressive treatments.
  • Diabetes mellitus, metabolic bone disease, ongoing treatment with bisphosphonates drugs, or pregnancy.
  • Anticoagulant drugs, Endocarditis risk factors, renal and hepatic failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2021

First Posted

March 1, 2021

Study Start

March 1, 2018

Primary Completion

September 1, 2018

Study Completion

December 1, 2019

Last Updated

March 1, 2021

Record last verified: 2021-02

Locations

EG(1)