Modified Surgical Technique for Lateral Block Augmentation Prior to Implant Installation

Modified Surgical Technique for Lateral Block Augmentation Prior to Implant Installation - A Pilot Study on 10 Patients With Histological Assessment

Evaluation of the surgical result (augmentation volume, proportion of newly formed bone) after perforation of the bone block in the course of lateral block augmentation prior to planned implant installation.

Study Overview

• Status: Active, not recruiting
• Conditions: Bone Augmentation
• Intervention / Treatment: Other: block perforation

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 130 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• single tooth gap in need of lateral bone augmentation prior to implant installation

Exclusion Criteria:

• untreated periodontal disease
• systemic disease and/or medication intake with significant effect on bone healing

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: block perforation	Other: block perforation; The bone block used for lateral bone augmentation will be perforated several times.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Histomorphometry	% of new bone formation	at implant installation (approximately 6 months after augmentation)
Radiographic	Volume gain (mm3) after block augmentation at the buccal aspect	6 months after block augmentation
Radiographic	Volume gain (mm3) after block augmentation at the buccal aspect	12 months after block augmentation

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2016
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: April 9, 2022
• First Submitted That Met QC Criteria: April 15, 2022
• First Posted (Actual): April 21, 2022

Study Record Updates

• Last Update Posted (Actual): April 21, 2022
• Last Update Submitted That Met QC Criteria: April 15, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 1401/2016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No