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Modified Ridge Splitting Technique Using Autogenous Bone Blocks (MRS) (MRS)

Primary Purpose

Alveolar Bone Resorption, Alveolar Ridge Enlargement

Status
Unknown status
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
Alveolar ridge splitting
Creating osteotomies with piezoelectric device
Sponsored by
Semmelweis University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alveolar Bone Resorption

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Semmelweis UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Autograft

Arm Description

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

Outcomes

Primary Outcome Measures

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.
BV/TV bone volume fraction
Bone volume compared to total volume in micro-CT reconstruction

Secondary Outcome Measures

Newly formed bone percentage
Newly formed bone area compared to total area in histomorphometry

Full Information

First Posted
June 4, 2021
Last Updated
August 10, 2021
Sponsor
Semmelweis University
Collaborators
NSK Europe GmbH, Hungarian Dental Association
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1. Study Identification

Unique Protocol Identification Number
NCT05005858
Brief Title
Modified Ridge Splitting Technique Using Autogenous Bone Blocks (MRS)
Acronym
MRS
Official Title
Modified Ridge Splitting Technique Using Autogenous Bone Blocks (MRS)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 14, 2019 (Actual)
Primary Completion Date
August 1, 2020 (Actual)
Study Completion Date
January 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Semmelweis University
Collaborators
NSK Europe GmbH, Hungarian Dental Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Patients were required to rinse with a 0.2% chlorhexidine solution for 1 min before surgery. Under local anesthesia, a full-thickness flap was raised from a crestal incision with a mesial releasing incision to access the alveolar ridge and the retromolar area. A midcrestal osteotomy was preformed, leaving a safety zone of at least 2 mm from the adjacent tooth. Two vertical releasing osteotomies were performed at the mesial and distal ends of the mid-crestal osteotomy. Apically, the vertical osteotomies were connected horizontally with a superficial corticotomy. Osteotomies and corticotomies were carried out using a piezoelectronic device (NSK Variosurg3 Ultrasonic Bone Surgery System, NSK Europe GmbH, Eschborn, Germany.) Chisels were inserted in the midcrestal osteotomy to create a green-stick fracture to allow extensive mobilization of the buccal cortical. After mobilization of the buccal cortical, an autologous bone block with dimensions corresponding to that of the bone defect created in the recipient site was harvested from the retromolar area and was placed as a spacer between the buccal and lingual cortical plates. The block was stabilized using osteosynthesis screws (Meisinger Screw System, Hager and Meisinger GmbH, Neuss, Germany). Both lingual and buccal flaps were mobilized to allow tension-free primary closure. The flap was closed with horizontal mattress sutures, and then single interrupted sutures closed the edges of the flaps. Suture removal took place after 14 days. All patients received amoxicillin and clavulanate (Aktil Duo 875 mg/125 mg, Sandoz Hungária Kft., Budapest, Hungary) 1 g twice per day, starting at the day of the surgery and continuing for 7 days. In case of amoxicillin allergy, clindamycin (Dalacin 300 mg, Pfizer Inc., New York, NY, USA) was prescribed four times a day for 7 days. Furthermore, a non-steroid anti-inflammatory drug, diclofenac (Cataflam 50 mg, Novartis Hungária Kft., Budapest, Hungary), 3 times a day for 3 days, and 0.2% chlorhexidine mouth rinse (Corsodyl, GlaxoSmithKline Consumer Healthcare GmbH & Co. KG, München, Germany), twice a day for 2 weeks, were prescribed to the patients. During the healing period, patients did not wear temporary prostheses. Surgical re-entry took place after 3 months of healing. Implant bed preparation was carried out with rotatory instruments powered by a surgical micromotor (MasterSurg Surgical Systems, KaVo Dental Systems Japan, Co., Ltd., Tokyo, Japan). A trephine drill with an external diameter of 3.0 mm and an internal diameter of 2.0 mm (330 205 486 001 020 Hager and Meisinger GmbH, Neuss, Germany) with external cooling at a drill rotation speed of 800 rpm to the depth of 8 mm was used to remove bone core biopsy samples for histologic analysis. Implant beds were finalized according to the instructions of the implant manufacturer at a rotation speed of 800 rpm. Implants (Nobel Replace Conical Connection, Nobel Biocare AG, Kloten, Switzerland) were placed submerged in the augmented bone. Implant uncovery procedure took place 3 months after implant placement. Clinical measurements: 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. Histomorphometry: Bone core biopsy material was fixed in 10% buffered formaldehyde solution. Following decalcination and dehydration, the biopsy material was embedded in paraffin and 20 µm sections were prepared. The sections were stained with routine haematoxylin eosin stain. Sections were evaluated under a light microscope in magnification 40×-400× . Micro-CT analysis: The bone core biopsy samples were scanned using a microcomputed tomography (μCT) scanner (Skyscan 1172 X-ray microtomograph, Bruker µCT, Kontich, Belgium).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Bone Resorption, Alveolar Ridge Enlargement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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
Masking
None (Open Label)
Masking Description
The specialis tasked with histomorphometric, micro-CT analysis has no knowledge on the intervention method
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Autograft
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Alveolar ridge splitting
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Creating osteotomies with piezoelectric device
Intervention Description
Osteotomies were carried out with piezoelectric surgery device (NSK Variosurg3 Ultrasonic Bone Surgery System, NSK Europe GmbH, Eschborn, Germany)
Primary Outcome Measure Information:
Title
Clinical measurements
Description
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.
Time Frame
After the 3-month healing period, at the implant placement.
Title
BV/TV bone volume fraction
Description
Bone volume compared to total volume in micro-CT reconstruction
Time Frame
After the 3-month healing period
Secondary Outcome Measure Information:
Title
Newly formed bone percentage
Description
Newly formed bone area compared to total area in histomorphometry
Time Frame
After the 3-month healing period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Mandibular ridge width at least 3 mm; Ridge height at least 11 mm; Spongiosa between the two cortical plates at least 1 mm Exclusion Criteria: History of uncontrolled medical disorders; History of systemic diseases or medication that alter bone metabolism; Poor oral hygiene; Smoking
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dorottya Penzes
Phone
003613176600
Email
penzes.dorottya@dent.semmelweis-univ.hu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Márton Kivovics, Ph.D
Organizational Affiliation
Semmelweis University
Official's Role
Study Director
Facility Information:
Facility Name
Semmelweis University
City
Budapest
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dorottya Penzes
Email
penzes.dorottya@dent.semmelweis-univ.hu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32932942
Citation
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.
Results Reference
result
Links:
URL
http://www.mdpi.com/1996-1944/13/18/4036
Description
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Modified Ridge Splitting Technique Using Autogenous Bone Blocks (MRS)

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