Alveolar Bone ResorptionNCT05548049

Autogenous Ramus Bone Block Harvesting With Piezosurgery

A study testing Bone harvesting from ramus area with piezosurgery for autogenous bone augmentation and Bone harvesting from ramus area with conventional burs for autogenous bone augmentation in people with Alveolar Bone Resorption, run by Marmara University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The aim of this randomized prospective clinical trial was to evaluate the outcome of bone block harvesting from the retromolar region using the Conventional and Piezosurgery Method. The study was planned on 19 patients (13F,6M) on 31 donor sites. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Alveolar Bone Resorption
What is being tested?: Bone harvesting from ramus area with piezosurgery for autogenous bone augmentation and Bone harvesting from ramus area with conventional burs for autogenous bone augmentation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 Sep 2021to 1 Jul 2022
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 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

ASA I-II
The main inclusion criteria were severe alveolar ridge atrophy in the horizontal plane (≤4 mm) and no accompanying vertical defect, according to preoperative CBCT scans.

Who cannot join

Individuals who had systemic disease affecting bone or soft tissue metabolism
Smokers (more than 10 cigarettes a day
Alcohol dependent
Systemic disease affecting bone or soft tissue metabolism
Donor field in the mouth of another region (simfiz, tuber etc.) or any extra-oral field is planned to be used
Patients with cleft lip-palate or defect exceeding the alveolar crest
Grafts applied to defects caused by tumors, osteoradionecrosis, or congenital malformations
Patients with an unstable systemic condition such as metabolic bone disease, uncontrolled diabetes, or untreated hypothyroidism, as well as smokers, patients undergoing radiation therapy or chemotherapy

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Marmara University School of Dentistry
Istanbul, 34854

Other trials in Turkey (Türkiye)

About this study

Official title: A Prospective Randomized Trial Comparing Conventional And Piezosurgery Method In Mandibular Bone Block Harvesting From The Retromolar Region

The aim of this randomized prospective clinical trial was to evaluate the outcome of bone block harvesting from the retromolar region using the Conventional and Piezosurgery Method.

The study was planned on 19 patients (13F,6M) on 31 donor sites. In patients with bilateral bone harvesting, the donor site and the surgical method to be used were determined by the randomization protocol, while in patients with bone harvesting from a single site, the donor site was determined by considering parameters such as proximity to the operation site and distance to the inferior alveolar nerve. Clinical parameters such as operation time, pain, swelling, trismus, nerve damage were evaluated.

Conditions: Alveolar Bone Resorption
Being tested: Bone harvesting from ramus area with piezosurgery for autogenous bone augmentation, Bone harvesting from ramus area with conventional burs for autogenous bone augmentation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bone harvesting from ramus area with piezosurgery for autogenous bone augmentationDevice
In this invervention, the piezo-surgical device settings were set to irrigation: '4', function: 'cortical', light: 'auto'. After the full-thickness flap was lifted with the periosteal elevator, superior and vertical osteotomies were performed with the OT-12 piezo-surgical tip. Lower horizontal osteotomies were performed using OT8-L or OT-8-R piezo tips according to the studied quadrant, combining the vertical osteotomy.
Bone harvesting from ramus area with conventional burs for autogenous bone augmentationDevice
In control group, After the full-thickness flap is lifted with the periosteal elevator, using a thin #9 fissure burand the surgical handpiece S-11 Straight tip , the physiodispenser settings are according to the manufacturer's recommendations. The osteotomy was performed after it was adjusted to 40,000 rpm as appropriate. Bone incisions were completed with a round bur to combine the lower horizontal osteotomies and 2 vertical osteotomies. The osteotomies were completed with the help of a thin flat drill, and the block graft was carefully separated from the donor site.

Study groups in NCT05548049
Study group	Role	What they receive
Piezosurgery Group	Experimental	In the experimental group, a piezosurgical device was used to harvest the bone block from the ramus area. Receives: Device: Bone harvesting from ramus area with piezosurgery for autogenous bone augmentation
Conventional Group	Active comparator	In the experimental group, a conventional burr was used to harvest the bone block from the ramus area. Receives: Device: Bone harvesting from ramus area with conventional burs for autogenous bone augmentation

What is being measured

The primary outcome is the main question the study is designed to answer.

Osteotomy time
The time from the start of the osteotomy to the luxation of the bone block was measured with the help of a digital stopwatch.
Measured: Intraoperative

Secondary outcomes (5)

Change in pain
Postoperative pain was assessed using a Visual Analogue Scale (VAS) ranging from the absence of pain (score 0) to the most severe pain imaginable
Measured: 7 days
Change in Mouth opening
The distance between the mesio-incisal corners of the upper and lower central incisors was measured with the help of a ruler when the mouth opening was at its maximum.
Measured: 7 days
Change in Oral Health-related Quality of Life
Evaluated by OHIP-14
Measured: 14 days
Operation time
The total time from the first incision of the operation site to the last suture was measured with the help of a digital stopwatch as the operation time.
Measured: Intraoperative
Change in facial swelling
With the technique described by Neupert ; Angle of mandible-tragus Angle of mandible-lateral canthus of eye Mandible corner-nose wing Angle of mandible oral-commissures Measurements were made with a tape measure from 5 points, with the mandible corner-pogonion.
Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 20211 Jul 2022

First posted21 Sep 2022
Study start1 Sep 2021
Primary completion1 Mar 2022
Study completion1 Jul 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05548049
Sponsor's protocol ID: MUDHF_FB_002
Status last verified: Sep 2022
First submitted: 14 Sep 2022
Last updated: 21 Sep 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

Publications

Silva FM, Cortez AL, Moreira RW, Mazzonetto R. Complications of intraoral donor site for bone grafting prior to implant placement. Implant Dent. 2006 Dec;15(4):420-6. doi: 10.1097/01.id.0000246225.51298.67.
PubMed 17172961
Sohn DS, Ahn MR, Lee WH, Yeo DS, Lim SY. Piezoelectric osteotomy for intraoral harvesting of bone blocks. Int J Periodontics Restorative Dent. 2007 Apr;27(2):127-31.
PubMed 17514884
Robiony M, Polini F, Costa F, Zerman N, Politi M. Ultrasonic bone cutting for surgically assisted rapid maxillary expansion (SARME) under local anaesthesia. Int J Oral Maxillofac Surg. 2007 Mar;36(3):267-9. doi: 10.1016/j.ijom.2006.08.013. Epub 2006 Nov 16.
PubMed 17112705
Hanser T, Doliveux R. MicroSaw and Piezosurgery in Harvesting Mandibular Bone Blocks from the Retromolar Region: A Randomized Split-Mouth Prospective Clinical Trial. Int J Oral Maxillofac Implants. 2018 Mar/Apr;33(2):365-372. doi: 10.11607/jomi.4416.
PubMed 29534125
Sittitavornwong S, Gutta R. Bone graft harvesting from regional sites. Oral Maxillofac Surg Clin North Am. 2010 Aug;22(3):317-30, v-vi. doi: 10.1016/j.coms.2010.04.006.
PubMed 20713265
Pereira RS, Pavelski MD, Griza GL, Boos FBJD, Hochuli-Vieira E. Prospective evaluation of morbidity in patients who underwent autogenous bone-graft harvesting from the mandibular symphysis and retromolar regions. Clin Implant Dent Relat Res. 2019 Aug;21(4):753-757. doi: 10.1111/cid.12789. Epub 2019 May 16.
PubMed 31094060
Chiapasco M, Casentini P, Zaniboni M. Bone augmentation procedures in implant dentistry. Int J Oral Maxillofac Implants. 2009;24 Suppl:237-59.
PubMed 19885448
Starch-Jensen T, Deluiz D, Deb S, Bruun NH, Tinoco EMB. Harvesting of Autogenous Bone Graft from the Ascending Mandibular Ramus Compared with the Chin Region: a Systematic Review and Meta-Analysis Focusing on Complications and Donor Site Morbidity. J Oral Maxillofac Res. 2020 Nov 30;11(3):e1. doi: 10.5037/jomr.2020.11301. eCollection 2020 Jul-Sep.
PubMed 33262880
Nkenke E, Neukam FW. Autogenous bone harvesting and grafting in advanced jaw resorption: morbidity, resorption and implant survival. Eur J Oral Implantol. 2014 Summer;7 Suppl 2:S203-17.
PubMed 24977256
Nielsen HB, Starch-Jensen T. Lateral ridge augmentation in the posterior part of the mandible with an autogenous bone block graft harvested from the ascending mandibular ramus. A 10-year retrospective study. J Stomatol Oral Maxillofac Surg. 2021 Apr;122(2):141-146. doi: 10.1016/j.jormas.2020.05.020. Epub 2020 May 29.
PubMed 32480048
Nkenke E, Stelzle F. Clinical outcomes of sinus floor augmentation for implant placement using autogenous bone or bone substitutes: a systematic review. Clin Oral Implants Res. 2009 Sep;20 Suppl 4:124-33. doi: 10.1111/j.1600-0501.2009.01776.x.
PubMed 19663959
Bayram F, Demirci A. A randomized controlled trial comparing conventional and piezosurgery methods in mandibular bone block harvesting from the retromolar region. BMC Oral Health. 2023 Dec 9;23(1):986. doi: 10.1186/s12903-023-03739-9.
PubMed 38071300

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Not yet recruitingPhase 1/2
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All Alveolar Bone Resorption trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Randomized Trial Comparing Conventional And Piezosurgery Method In Mandibular Bone Block Harvesting From The Retromolar Region
ClinicalTrials.gov ID: NCT05548049
Acronym / sponsor ID: MUDHF_FB_002
Conditions: Alveolar Bone Resorption
Study type: Interventional
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: Marmara UniversityUniversity, hospital or other
Study start: 1 Sep 2021 (actual)
Primary completion: 1 Mar 2022 (actual)
Study completion: 1 Jul 2022 (actual)
First posted: 21 Sep 2022 (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.

The aim of this randomized prospective clinical trial was to evaluate the outcome of bone block harvesting from the retromolar region using the Conventional and Piezosurgery Method.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Piezosurgery Group	Experimental	Device: Bone harvesting from ramus area with piezosurgery for autogenous bone augmentationIn the experimental group, a piezosurgical device was used to harvest the bone block from the ramus area.
Conventional Group	Active comparator	Device: Bone harvesting from ramus area with conventional burs for autogenous bone augmentationIn the experimental group, a conventional burr was used to harvest the bone block from the ramus area.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

ASA I-II
The main inclusion criteria were severe alveolar ridge atrophy in the horizontal plane (≤4 mm) and no accompanying vertical defect, according to preoperative CBCT scans.

Key exclusion criteria (8 listed)

Individuals who had systemic disease affecting bone or soft tissue metabolism
Smokers (more than 10 cigarettes a day
Alcohol dependent
Systemic disease affecting bone or soft tissue metabolism
Donor field in the mouth of another region (simfiz, tuber etc.) or any extra-oral field is planned to be used

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
Bone harvesting from ramus area with piezosurgery for autogenous bone augmentationIn this invervention, the piezo-surgical device settings were set to irrigation: '4', function: 'cortical', light: 'auto'. After the full-thickness flap was lifted with the periosteal elevator, superior and vertical osteotomies were performed with the OT-12 piezo-surgical tip. Lower horizontal osteotomies were performed using OT8-L or OT-8-R piezo tips according to the studied quadrant, combining the vertical osteotomy.	Device	Piezosurgery Group
Bone harvesting from ramus area with conventional burs for autogenous bone augmentationIn control group, After the full-thickness flap is lifted with the periosteal elevator, using a thin #9 fissure burand the surgical handpiece S-11 Straight tip , the physiodispenser settings are according to the manufacturer's recommendations. The osteotomy was performed after it was adjusted to 40,000 rpm as appropriate. Bone incisions were completed with a round bur to combine the lower horizontal osteotomies and 2 vertical osteotomies. The osteotomies were completed with the help of a thin flat drill, and the block graft was carefully separated from the donor site.	Device	Conventional Group

Primary outcome

Osteotomy time
Time frame: Intraoperative
The time from the start of the osteotomy to the luxation of the bone block was measured with the help of a digital stopwatch.

5 secondary outcomes

Change in pain
Time frame: 7 days
Change in Mouth opening
Time frame: 7 days
Change in Oral Health-related Quality of Life
Time frame: 14 days
Operation time
Time frame: Intraoperative
Change in facial swelling
Time frame: 7 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
Background: PubMed 17172961Silva FM, Cortez AL, Moreira RW, Mazzonetto R. Complications of intraoral donor site for bone grafting prior to implant placement. Implant Dent. 2006 Dec;15(4):420-6. doi: 10.1097/01.id.0000246225.51298.67.
Background: PubMed 17514884Sohn DS, Ahn MR, Lee WH, Yeo DS, Lim SY. Piezoelectric osteotomy for intraoral harvesting of bone blocks. Int J Periodontics Restorative Dent. 2007 Apr;27(2):127-31.
Background: PubMed 17112705Robiony M, Polini F, Costa F, Zerman N, Politi M. Ultrasonic bone cutting for surgically assisted rapid maxillary expansion (SARME) under local anaesthesia. Int J Oral Maxillofac Surg. 2007 Mar;36(3):267-9. doi: 10.1016/j.ijom.2006.08.013. Epub 2006 Nov 16.
Background: PubMed 29534125Hanser T, Doliveux R. MicroSaw and Piezosurgery in Harvesting Mandibular Bone Blocks from the Retromolar Region: A Randomized Split-Mouth Prospective Clinical Trial. Int J Oral Maxillofac Implants. 2018 Mar/Apr;33(2):365-372. doi: 10.11607/jomi.4416.
Background: PubMed 20713265Sittitavornwong S, Gutta R. Bone graft harvesting from regional sites. Oral Maxillofac Surg Clin North Am. 2010 Aug;22(3):317-30, v-vi. doi: 10.1016/j.coms.2010.04.006.
Background: PubMed 31094060Pereira RS, Pavelski MD, Griza GL, Boos FBJD, Hochuli-Vieira E. Prospective evaluation of morbidity in patients who underwent autogenous bone-graft harvesting from the mandibular symphysis and retromolar regions. Clin Implant Dent Relat Res. 2019 Aug;21(4):753-757. doi: 10.1111/cid.12789. Epub 2019 May 16.
Background: PubMed 19885448Chiapasco M, Casentini P, Zaniboni M. Bone augmentation procedures in implant dentistry. Int J Oral Maxillofac Implants. 2009;24 Suppl:237-59.
Background: PubMed 33262880Starch-Jensen T, Deluiz D, Deb S, Bruun NH, Tinoco EMB. Harvesting of Autogenous Bone Graft from the Ascending Mandibular Ramus Compared with the Chin Region: a Systematic Review and Meta-Analysis Focusing on Complications and Donor Site Morbidity. J Oral Maxillofac Res. 2020 Nov 30;11(3):e1. doi: 10.5037/jomr.2020.11301. eCollection 2020 Jul-Sep.
Background: PubMed 24977256Nkenke E, Neukam FW. Autogenous bone harvesting and grafting in advanced jaw resorption: morbidity, resorption and implant survival. Eur J Oral Implantol. 2014 Summer;7 Suppl 2:S203-17.
Background: PubMed 32480048Nielsen HB, Starch-Jensen T. Lateral ridge augmentation in the posterior part of the mandible with an autogenous bone block graft harvested from the ascending mandibular ramus. A 10-year retrospective study. J Stomatol Oral Maxillofac Surg. 2021 Apr;122(2):141-146. doi: 10.1016/j.jormas.2020.05.020. Epub 2020 May 29.
Background: PubMed 19663959Nkenke E, Stelzle F. Clinical outcomes of sinus floor augmentation for implant placement using autogenous bone or bone substitutes: a systematic review. Clin Oral Implants Res. 2009 Sep;20 Suppl 4:124-33. doi: 10.1111/j.1600-0501.2009.01776.x.
Derived from this study: PubMed 38071300Bayram F, Demirci A. A randomized controlled trial comparing conventional and piezosurgery methods in mandibular bone block harvesting from the retromolar region. BMC Oral Health. 2023 Dec 9;23(1):986. doi: 10.1186/s12903-023-03739-9.
Individual participant dataSharing planned: Yes

Related trials for Alveolar Bone Resorption

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Not yet recruitingPhase 1/2
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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 inclusion and 8 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: finished, as of the sponsor's last update on 21 Sep 2022. 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 Turkey (Türkiye). 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Osteotomy time (time frame: Intraoperative). 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 NCT05548049, which also lists 12 linked publications.

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 21 Sep 2022.