AzTrials
AzTrials

Alveolar Bone LossNCT04022265

Bone Healing at Implants Installed in Sites Prepared Either With a Sonic Device or Drills

A study testing implant placement in people with Alveolar Bone Loss, run by ARDEC Academy at 1 site in Colombia.

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 purpose was to evaluate histomorphometrically the early healing at implants installed in sites prepared with either a sonic device or conventional drills. Read more about this study

Who is it for?
Ages 25 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Alveolar Bone Loss
What is being tested?
implant placement
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteColombia
Study dates
4 Feb 2016to 15 Dec 2017
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 25 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • presence of an edentulous atrophic zone in the posterior segment of the maxilla
  • height of the sinus floor ≥10 mm
  • ≥ 25 years of age;
  • smoking ≤10 cigarettes per day
  • good general health
  • no contraindication for oral surgical procedures
  • not being pregnant.

Who cannot join

  • presence of systemic disorders
  • chemotherapy or radiotherapy
  • smokers >10 cigarettes per day
  • previous bone augmentation procedures in the same region.

Trial locations and contacts

1 site in 1 country.

Colombia1 site

  • Colombia

    Cartagena, Cartagena, 5710

Other trials in Colombia

About this study

Official title: Bone Healing at Implants Installed in Sites Prepared Either With a Sonic Device or Drills. A Split-mouth Histomorphometric Randomized Controlled Trial

The purpose was to evaluate histomorphometrically the early healing at implants installed in sites prepared with either a sonic device or conventional drills.

Read the detailed description

Sixteen volunteer patients will be recruited. Two titanium mini-implants will be installed in the distal segments of the maxilla in recipient sites prepared with either a sonic device or conventional drills. Biopsies containing the mini-implants will be retrieved after 2 weeks in eight patients, and after 6 weeks in the other eight patients. Histomorphometric analyses will be performed

Being tested
implant placement
Medical subject headings
Alveolar Bone Loss

What participants receive

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

  • implant placementDevice

    Also called implant surgery, prosthesis

    Full-thickness muco-periosteal flaps will be elevated, and the alveolar bone exposed to prepare the bed for the implant installation

Study groups in NCT04022265
Study groupRoleWhat they receive
Control Site -Drill siteActive comparatorThe control sites (Drills) will be prepared with a lanceolate drill (FS 230, Sweden / Martina), with a maximum diameter of 2.3 mm,
Receives: Device: implant placement
Test site -sonic siteExperimentaltest sites will be prepared with conical diamond inserts of increasing diameter (SFS99.000.014 to SFS99.000.024, Komet-Brasseler-GmbH, Germany) mounted on a sonic-air surgical instrument
Receives: Device: implant placement

What is being measured

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

  1. New bone in contact with the implant surface

    The percentages of new bone in contact with the implant surface will be evaluated in the histomorphometric analysis

    Measured: After 2 weeks to evaluate the healing prior to load with a prosthesis

  2. New bone in contact with the implant surface

    The percentages of new bone in contact with the implant surface will be evaluated in the histomorphometric analysis

    Measured: After 6 weeks, to evaluate the healing prior to load with a prosthesis

Secondary outcomes (2)

  1. The percentage of total mineralized bone in contact with the implant surface.

    The percentages of new bone in contact with the implant surface will be evaluated in the histomorphometric analysis

    Measured: After 2 weeks to evaluate the healing prior to load with a prosthesis

  2. The percentage of total mineralized bone in contact with the implant surface.

    The percentages of new bone in contact with the implant surface will be evaluated in the histomorphometric analysis

    Measured: After 6 weeks to evaluate the healing prior to load with a prosthesis

Timeline

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

  1. First posted17 Jul 2019
  2. Study start4 Feb 2016
  3. Primary completion30 Aug 2017
  4. Study completion15 Dec 2017

Resources

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
Model description
Clinical Trial
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04022265
Sponsor's protocol ID
protocol #05-2014
Status last verified
Jul 2019
First submitted
11 Jul 2019
Last updated
19 Jul 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Will be shared after publication

Publications

  • Atieh MA, Alsabeeha NHM, Tawse-Smith A, Duncan WJ. Piezoelectric versus conventional implant site preparation: A systematic review and meta-analysis. Clin Implant Dent Relat Res. 2018 Apr;20(2):261-270. doi: 10.1111/cid.12555. Epub 2017 Nov 16.

    PubMed 29148161

  • Bengazi F, Lang NP, Canciani E, Vigano P, Velez JU, Botticelli D. Osseointegration of implants with dendrimers surface characteristics installed conventionally or with Piezosurgery(R). A comparative study in the dog. Clin Oral Implants Res. 2014 Jan;25(1):10-5. doi: 10.1111/clr.12082. Epub 2012 Dec 12.

    PubMed 23231427

  • Vigano P, Botticelli D, Salata LA, Schweikert MT, Urbizo Velez J, Lang NP. Healing at implant sites prepared conventionally or by means of Sonosurgery (R). An experimental study in dogs. Clin Oral Implants Res. 2015 Apr;26(4):377-382. doi: 10.1111/clr.12348. Epub 2014 Feb 13.

    PubMed 24524198

  • Maurer P, Kriwalsky MS, Block Veras R, Vogel J, Syrowatka F, Heiss C. Micromorphometrical analysis of conventional osteotomy techniques and ultrasonic osteotomy at the rabbit skull. Clin Oral Implants Res. 2008 Jun;19(6):570-5. doi: 10.1111/j.1600-0501.2007.01516.x.

    PubMed 18474063

  • Schaeren S, Jaquiery C, Heberer M, Tolnay M, Vercellotti T, Martin I. Assessment of nerve damage using a novel ultrasonic device for bone cutting. J Oral Maxillofac Surg. 2008 Mar;66(3):593-6. doi: 10.1016/j.joms.2007.03.025. No abstract available.

    PubMed 18280402

  • Stacchi C, Berton F, Turco G, Franco M, Navarra CO, Andolsek F, Maglione M, Di Lenarda R. Micromorphometric analysis of bone blocks harvested with eight different ultrasonic and sonic devices for osseous surgery. J Craniomaxillofac Surg. 2016 Sep;44(9):1143-51. doi: 10.1016/j.jcms.2016.04.024. Epub 2016 Apr 22.

    PubMed 27527676

  • Amghar-Maach S, Sanchez-Torres A, Camps-Font O, Gay-Escoda C. Piezoelectric surgery versus conventional drilling for implant site preparation: a meta-analysis. J Prosthodont Res. 2018 Oct;62(4):391-396. doi: 10.1016/j.jpor.2018.04.004. Epub 2018 May 26.

    PubMed 29843978

  • Sendyk DI, de Oliveira NK, Pannuti CM, da Graca Naclerio-Homem M, Wennerberg A, Deboni MCZ. Conventional Drilling Versus Piezosurgery for Implant Site Preparation: A Meta-Analysis. J Oral Implantol. 2018 Oct;44(5):400-405. doi: 10.1563/aaid-joi-D-17-00091. Epub 2018 Mar 27.

    PubMed 29583059

  • Stacchi C, Vercellotti T, Torelli L, Furlan F, Di Lenarda R. Changes in implant stability using different site preparation techniques: twist drills versus piezosurgery. A single-blinded, randomized, controlled clinical trial. Clin Implant Dent Relat Res. 2013 Apr;15(2):188-97. doi: 10.1111/j.1708-8208.2011.00341.x. Epub 2011 Apr 19.

    PubMed 21682844

  • Preti G, Martinasso G, Peirone B, Navone R, Manzella C, Muzio G, Russo C, Canuto RA, Schierano G. Cytokines and growth factors involved in the osseointegration of oral titanium implants positioned using piezoelectric bone surgery versus a drill technique: a pilot study in minipigs. J Periodontol. 2007 Apr;78(4):716-22. doi: 10.1902/jop.2007.060285.

    PubMed 17397320

  • Geminiani A, Papadimitriou DE, Ercoli C. Maxillary sinus augmentation with a sonic handpiece for the osteotomy of the lateral window: a clinical report. J Prosthet Dent. 2011 Nov;106(5):279-83. doi: 10.1016/S0022-3913(11)00143-0.

    PubMed 22024176

  • Geminiani A, Weitz DS, Ercoli C, Feng C, Caton JG, Papadimitriou DE. A comparative study of the incidence of Schneiderian membrane perforations during maxillary sinus augmentation with a sonic oscillating handpiece versus a conventional turbine handpiece. Clin Implant Dent Relat Res. 2015 Apr;17(2):327-34. doi: 10.1111/cid.12110. Epub 2013 Jul 9.

    PubMed 23837594

  • Papadimitriou DE, Geminiani A, Zahavi T, Ercoli C. Sonosurgery for atraumatic tooth extraction: a clinical report. J Prosthet Dent. 2012 Dec;108(6):339-43. doi: 10.1016/S0022-3913(12)00169-2.

    PubMed 23217465

  • Agabiti I, Cappare P, Gherlone EF, Mortellaro C, Bruschi GB, Crespi R. New surgical technique and distraction osteogenesis for ankylosed dental movement. J Craniofac Surg. 2014 May;25(3):828-30. doi: 10.1097/SCS.0000000000000737.

    PubMed 24777021

  • Agabiti I, Bernardello F, Nevins M, Wang HL. Impacted canine extraction by ridge expansion using air scaler surgical instruments: a case report. Int J Periodontics Restorative Dent. 2014 Sep-Oct;34(5):681-7. doi: 10.11607/prd.1884.

    PubMed 25171039

Questions about this trial

What is this clinical trial studying?

A study testing implant placement in people with Alveolar Bone Loss, run by ARDEC Academy at 1 site in Colombia.

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 7 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: finished, as of the sponsor's last update on 19 Jul 2019. 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 Colombia. 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?

New bone in contact with the implant surface (time frame: After 2 weeks to evaluate the healing prior to load with a prosthesis). 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 NCT04022265, which also lists 20 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 19 Jul 2019.

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