Alveolar Bone ResorptionMRSNCT05005858
Modified Ridge Splitting Technique Using Autogenous Bone Blocks (MRS)
A study testing Alveolar ridge splitting and Creating osteotomies with piezoelectric device in people with Alveolar Bone Resorption and Alveolar Ridge Enlargement, run by Semmelweis University at 1 site in Hungary.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Resorption, Alveolar Ridge Enlargement
- What is being tested?
- Alveolar ridge splitting and Creating osteotomies with piezoelectric device
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteHungary
- Study dates
- 14 May 2019to 1 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Mandibular ridge width at least 3 mm;
- Ridge height at least 11 mm;
- Spongiosa between the two cortical plates at least 1 mm
Who cannot join
- History of uncontrolled medical disorders;
- History of systemic diseases or medication that alter bone metabolism;
- Poor oral hygiene;
- Smoking
Trial locations and contacts
1 site in 1 country.
Hungary1 site, 1 recruiting
- Recruiting
Semmelweis University
Budapest
Dorottya Penzes, penzes.dorottya@dent.semmelweis-univ.hu
About this study
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.
Read the 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).
- Being tested
- Alveolar ridge splitting, Creating osteotomies with piezoelectric device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alveolar ridge splittingProcedure or surgery
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.
Creating osteotomies with piezoelectric deviceDevice
Osteotomies were carried out with piezoelectric surgery device (NSK Variosurg3 Ultrasonic Bone Surgery System, NSK Europe GmbH, Eschborn, Germany)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Alveolar ridge splitting; Device: Creating osteotomies with piezoelectric device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: After the 3-month healing period
Secondary outcomes (1)
Newly formed bone percentage
Newly formed bone area compared to total area in histomorphometry
Measured: After the 3-month healing period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start14 May 2019
- Primary completion1 Aug 2020
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alveolar Bone ResorptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Collaborators
- NSK Europe GmbH, Hungarian Dental Association
- Responsible party
- Sponsor
- Investigators
- Márton Kivovics, Ph.D, Study director, Semmelweis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05005858
- Sponsor's protocol ID
- 52158-2/2015/EKU
- Acronym
- MRS
- Status last verified
- Jun 2021
- First submitted
- 4 Jun 2021
- Last updated
- 16 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32932942
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Ridge Splitting Technique Using Autogenous Bone Blocks (MRS)
- ClinicalTrials.gov ID
- NCT05005858
- Acronym / sponsor ID
- MRS / 52158-2/2015/EKU
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Collaborators
- NSK Europe GmbH, Hungarian Dental Association
- Study start
- 14 May 2019 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 16 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| Autograft | Experimental | Procedure: Alveolar ridge splitting, Device: Creating osteotomies with piezoelectric deviceThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Mandibular ridge width at least 3 mm;
- Ridge height at least 11 mm;
- Spongiosa between the two cortical plates at least 1 mm
Key exclusion criteria (4 listed)
- History of uncontrolled medical disorders;
- History of systemic diseases or medication that alter bone metabolism;
- Poor oral hygiene;
- Smoking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alveolar ridge splittingPatients 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. | Procedure or surgery | Autograft |
| Creating osteotomies with piezoelectric deviceOsteotomies were carried out with piezoelectric surgery device (NSK Variosurg3 Ultrasonic Bone Surgery System, NSK Europe GmbH, Eschborn, Germany) | Device | Autograft |
Primary outcome
Clinical measurements
Time frame: After the 3-month healing period, at the implant placement.
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
Time frame: After the 3-month healing period
Bone volume compared to total volume in micro-CT reconstruction
1 secondary outcome
Newly formed bone percentage
Time frame: After the 3-month healing period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2021.
- Results publication: PubMed 32932942Penzes 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Márton Kivovics, Ph.D study director
Semmelweis University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alveolar ridge splitting and Creating osteotomies with piezoelectric device in people with Alveolar Bone Resorption and Alveolar Ridge Enlargement, run by Semmelweis University at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dorottya Penzes (003613176600, penzes.dorottya@dent.semmelweis-univ.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical measurements (time frame: After the 3-month healing period, at the implant placement.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05005858, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2021.