NCT03183336

Brief Summary

20 subjects presenting with horizontal mandibular ridge width less than 5 mm were selected and randomly divided two groups (10 in each group). the first group received interpositional block grafts (harvested from the chin and ramus) covered with Platelet-rich fibrin membrane. the second group received onlay block grafts (harvested from the chin and ramus) and covered with Platelet-rich fibrin membrane. the grafts are left for 4 months. the alveolar ridge width dimensions is then measured using radiographic analysis using cone-beam computed tomography scans

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 Jul 2016

Status
unknown

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

July 1, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 12, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

July 11, 2017

Status Verified

July 1, 2017

Enrollment Period

1.1 years

First QC Date

June 6, 2017

Last Update Submit

July 6, 2017

Conditions

Horizontal Ridge DeficiencyBlock Graft

Outcome Measures

Primary Outcomes (1)

  • alveolar ridge width gained

    radiographic analysis following ridge augmentation using Cone beam computed tomography

    4 months

Secondary Outcomes (1)

  • patient morbidity following the surgical procedure

    14 days

Study Arms (2)

Interpositional block graft

EXPERIMENTAL

ridge split interpositional block graft

Procedure: ridge split interpositional block graft

Onlay block graft

ACTIVE COMPARATOR

decortication onlay block graft

Procedure: decortication Onlay block graft

Interventions

ridge split interpositional block graftPROCEDURE
Interpositional block graft
decortication Onlay block graftPROCEDURE
Onlay block graft

Eligibility Criteria

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

You may qualify if:

  • Patients of both sexes with a minimum vertical bone height above the inferior alveolar canal of 10mm in the edentulous region.
  • Patients should have ridge thickness less than 5mm measured 2mm from the alveolar crest Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome.

You may not qualify if:

  • Patients with any systemic disease that may affect normal bone healing. Patients with drug allergies, drug or alcohol abuse, periodontal diseases or poor oral hygiene

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

June 6, 2017

First Posted

June 12, 2017

Study Start

July 1, 2016

Primary Completion

August 1, 2017

Study Completion

September 1, 2017

Last Updated

July 11, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will share