NCT04376320

Brief Summary

The aim of this study is to compare two pre-prosthetic surgical techniques for augmentation of vertical mandibular ridge defects in preparation for implant placement, the first using customized ceramic membranes and the second using tenting titanium screws in conjunction with particulate bone graft and collagen membrane (modified sausage technique).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2020

Shorter than P25 for not_applicable

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

April 1, 2020

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

April 29, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 6, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2020

Completed
Last Updated

November 4, 2020

Status Verified

November 1, 2020

Enrollment Period

6 months

First QC Date

April 29, 2020

Last Update Submit

November 2, 2020

Conditions

Alveolar Ridge Enlargement

Outcome Measures

Primary Outcomes (1)

  • mean percentage of change of alveolar bone height

    change of alveolar bone height after surgery

    6 months

Study Arms (2)

Group 1(ceramic membrane)

ACTIVE COMPARATOR

using customized ceramic membranes for augmentation of vertical mandibular ridge defects in preparation for implant placement

Device: customised ceramic sheets (Group 1)

Group 2 (modified sausage technique)

ACTIVE COMPARATOR

using tenting titanium screws in conjunction with particulate bone graft and collagen membrane (modified sausage technique) for augmentation of vertical mandibular ridge defects in preparation for implant placement

Combination Product: modified sausage technique (Group 2)

Interventions

customised ceramic sheets (Group 1)DEVICE

guided bone regeneration

Group 1(ceramic membrane)
modified sausage technique (Group 2)COMBINATION_PRODUCT

guided bone regeneration

Group 2 (modified sausage technique)

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • patients of both genders
  • with age range from 40 to 60 years,
  • having about 7 mm of vertical bone height in the posterior mandible above the inferior alveolar canal and
  • requiring prosthetic rehabilitation with dental implants.

You may not qualify if:

  • heavy smokers,
  • patients undergoing radiotherapy or chemotherapy,
  • those having infection or local lesions in the area of surgery, and
  • patients with bone diseases which may compromise the results

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry

Alexandria, 21411, 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 INVESTIGATOR
PI Title
Assistant Professor of Oral and Maxillofacial Surgery

Study Record Dates

First Submitted

April 29, 2020

First Posted

May 6, 2020

Study Start

April 1, 2020

Primary Completion

September 30, 2020

Study Completion

October 4, 2020

Last Updated

November 4, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)