Modified Ridge Splitting Technique Using Autogenous Bone Blocks (MRS)

NCT05005858 | Unknown

• 1 other identifier: 52158-2/2015/EKU
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

In this clinical study ridge splitting procedures are preformed using autogenous bone blocks. After a 3-month healing, at the time of dental implant placement bone core biopsy samples are harvested. The samples undergo micro-Ct and histomorphometric analysis.

Conditions

Alveolar Bone Resorption; Alveolar Ridge Enlargement

Outcome Measures

Primary Outcomes (2)

• Clinical measurements

  Clinical measurements were carried out using Williams probe (Karl Hammacher GmbH, Solingen, Germany) prior to ridge splitting surgery after the full thickness flap elevation, to evaluate the width of the alveolar ridge (preoperative measurement) and after a 3-month healing period, before implant placement (postoperative measurement). The width of the alveolar ridges was measured at 3, 10, and 15 mm from the reference point, which was the distal marginal bone of the last tooth of the quadrant. To ensure that preoperative and postoperative measurement sites corresponded, we placed the tip of the Williams probe on the reference point described and the markings of the probe to the highest ridge of the lingual cortical.

  After the 3-month healing period, at the implant placement.

• BV/TV bone volume fraction

  Bone volume compared to total volume in micro-CT reconstruction

  After the 3-month healing period

Secondary Outcomes (1)

• Newly formed bone percentage

  After the 3-month healing period

Study Arms (1)

Autograft

EXPERIMENTAL

The filler used in ridge splitting is autologous bone block harvested from mandible * Interventions: * Procedure: ridge splitting * Procedure: bone core biopsy * Device: dental implant placement * Measurement: clinical measurement with Williams probe * Micro-CT analysis * Histomorphometric measurements

Procedure: Alveolar ridge splitting; Device: Creating osteotomies with piezoelectric device

Interventions

Alveolar ridge splitting PROCEDURE

Patients with Kennedy Class I. and II. mandibles with insufficient bone width were included in this study. Ridge splitting was carried out with the use of a piezoelectric surgery device by preparing osteotomies and after mobilization of the buccal cortical by placing an autologous bone block harvested from the retromolar region as a spacer between the buccal and lingual cortical plates. Block-grafts were stabilized by osteosynthesis screws. Implant placement was carried out after a 3-month healing period.

Autograft

Creating osteotomies with piezoelectric device DEVICE

Osteotomies were carried out with piezoelectric surgery device (NSK Variosurg3 Ultrasonic Bone Surgery System, NSK Europe GmbH, Eschborn, Germany)

Autograft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mandibular ridge width at least 3 mm;
• Ridge height at least 11 mm;
• Spongiosa between the two cortical plates at least 1 mm

You may not qualify if:

• History of uncontrolled medical disorders;
• History of systemic diseases or medication that alter bone metabolism;
• Poor oral hygiene;
• Smoking

Sponsors & Collaborators

• Semmelweis University: lead
• NSK Europe GmbH: collaborator
• Hungarian Dental Association: collaborator

Study Sites (1)

Semmelweis University

Budapest, Hungary

RECRUITING

Related Publications (1)

• Penzes D, Simon F, Mijiritsky E, Nemeth O, Kivovics M. A Modified Ridge Splitting Technique Using Autogenous Bone Blocks-A Case Series. Materials (Basel). 2020 Sep 11;13(18):4036. doi: 10.3390/ma13184036.

  PMID: 32932942 RESULT

Study Officials

• Márton Kivovics, Ph.D

  Semmelweis University

  STUDY DIRECTOR

Central Study Contacts

Dorottya Penzes

CONTACT

003613176600; penzes.dorottya@dent.semmelweis-univ.hu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The specialis tasked with histomorphometric, micro-CT analysis has no knowledge on the intervention method
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: * Procedure: alveolar ridge splitting * Procedure: bone core biopsy After 3 month healing time reentry took place and bone core biopsy samples were collected from the augmented bone of the maxillary sinuses with a trephine drill. Biopsy samples were collected from the sites where the dental implants were to be placed. * Device: dental implant placement During reentry after bone biopsy dental implants were placed. * Clinical measurements: Measurements were carried out using Williams probe * Histomorphometric measurements * Micro-CT analysis

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: August 16, 2021
• Study Start: May 14, 2019
• Primary Completion: August 1, 2020
• Study Completion: January 1, 2023
• Last Updated: August 16, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)