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Missing Maxillary PremolarNCT03613415

Implant Stability Using Densah Bur Versus Expander

A study testing Expansion in people with Missing Maxillary Premolar, run by Cairo University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

evaluating use of Densah bur in thin ridge enhance implant's primary stability when compared to screw expander. Read more about this study

Who is it for?
Ages 25 to 50 years
Conditions the study is for
Missing Maxillary Premolar
What is being tested?
Expansion
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
Sep 2018to Feb 2020
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 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patients with partial edentulous maxillary premolar area with crestal thickness ranging from 4 to 6 mm.
  • Age 25 - 50 years.
  • No intraoral soft tissue or hard tissue pathosis.
  • No systemic condition contraindicating implant placement.

Who cannot join

  • Ridges thickness less than 4 mm.
  • Coexisting vertical defect.
  • Heavy smokers (more than 20 cigarettes per day).
  • Patients with systemic disease that may affect normal healing.
  • Patient with psychiatric problems.
  • History of radiation therapy to the head and neck region.

Trial locations and contacts

No sites are listed yet.

Ahmed H Mahmoud contact

00201001029723

ahmedhish14@hotmail.com

About this study

Official title: Evaluation of Implant's Primary Stability Using Densah Bur Versus Expander in Patients With Missing Maxillary Premolar (A Randomized Clinical Trial)

evaluating use of Densah bur in thin ridge enhance implant's primary stability when compared to screw expander.

Being tested
Expansion

What participants receive

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

  • ExpansionOther

    non invasive technique to increase thickness of thin ridge

Study groups in NCT03613415
Study groupRoleWhat they receive
Expansion by Densah burExperimental* Scrubbing and draping of the patient in a standard fashion for intra oral procedures followed by local anesthesia administration to the patient. * A mid crestal flap will be reflected. * For both groups the implant manufacturer's pilot drill will be used to perform a standard osteotomy of 10 mm depth. * Sequential use of Densah bur under copious irrigation. * An implant of 3.9*10 mm will be inserted. * Smart peg will be placed on implant and Osstell will be used to record ISQ. * Healing collars will be placed on implants. * Flap will be prepared for closure and suturing.
Receives: Other: Expansion
ExpanderActive comparatorScrubbing and draping of the patient in a standard fashion for intra oral procedures followed by local anesthesia administration to the patient. * A mid crestal flap will be reflected. * For both groups the implant manufacturer's pilot drill will be used to perform a standard osteotomy of 10 mm depth. * Sequential use of screw expanders. * An implant of 3.9*10 mm will be inserted. * Smart peg will be placed on implant and Osstell will be used to record ISQ. * Healing collars will be placed on implants. * Flap will be prepared for closure and suturing.
Receives: Other: Expansion

What is being measured

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

  1. implant's primary stability

    After implant placement, Implant stability will be measured by Ostell device.

    Measured: intraoperative at time of surgery

  2. implant's primary stability

    Implant stability will be measured by Ostell device.

    Measured: Implant stability will be measured at second week

  3. implant's primary stability

    Implant stability will be measured by Ostell device.

    Measured: Implant stability will be measured at fourth week

  4. implant's primary stability

    Implant stability will be measured by Ostell device.

    Measured: Implant stability will be measured at sixth week

  5. implant's primary stability

    Implant stability will be measured by Ostell device.

    Measured: Implant stability will be measured at eighth week

Timeline

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

  1. First posted3 Aug 2018
  2. Study startSep 2018 (estimated)
  3. Primary completionSep 2019 (estimated)
  4. Study completionFeb 2020 (estimated)

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
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03613415
Sponsor's protocol ID
Expansion by densah bur
Status last verified
Jul 2018
First submitted
23 Jul 2018
Last updated
3 Aug 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Zarb GA, Schmitt A. The longitudinal clinical effectiveness of osseointegrated dental implants: the Toronto study. Part III: Problems and complications encountered. J Prosthet Dent. 1990 Aug;64(2):185-94. doi: 10.1016/0022-3913(90)90177-e.

    PubMed 2202818

  • Branemark PI. Osseointegration and its experimental background. J Prosthet Dent. 1983 Sep;50(3):399-410. doi: 10.1016/s0022-3913(83)80101-2. No abstract available.

    PubMed 6352924

  • Branemark PI, Svensson B, van Steenberghe D. Ten-year survival rates of fixed prostheses on four or six implants ad modum Branemark in full edentulism. Clin Oral Implants Res. 1995 Dec;6(4):227-31. doi: 10.1034/j.1600-0501.1995.060405.x.

    PubMed 8603114

  • Albrektsson T, Branemark PI, Hansson HA, Lindstrom J. Osseointegrated titanium implants. Requirements for ensuring a long-lasting, direct bone-to-implant anchorage in man. Acta Orthop Scand. 1981;52(2):155-70. doi: 10.3109/17453678108991776.

    PubMed 7246093

  • Marquezan M, Osorio A, Sant'Anna E, Souza MM, Maia L. Does bone mineral density influence the primary stability of dental implants? A systematic review. Clin Oral Implants Res. 2012 Jul;23(7):767-74. doi: 10.1111/j.1600-0501.2011.02228.x. Epub 2011 Jun 2.

    PubMed 21635560

  • Trisi P, De Benedittis S, Perfetti G, Berardi D. Primary stability, insertion torque and bone density of cylindric implant ad modum Branemark: is there a relationship? An in vitro study. Clin Oral Implants Res. 2011 May;22(5):567-70. doi: 10.1111/j.1600-0501.2010.02036.x. Epub 2010 Nov 19.

    PubMed 21087320

  • Turkyilmaz I, Aksoy U, McGlumphy EA. Two alternative surgical techniques for enhancing primary implant stability in the posterior maxilla: a clinical study including bone density, insertion torque, and resonance frequency analysis data. Clin Implant Dent Relat Res. 2008 Dec;10(4):231-7. doi: 10.1111/j.1708-8208.2008.00084.x. Epub 2008 Apr 1.

    PubMed 18384409

  • Adell R, Lekholm U, Grondahl K, Branemark PI, Lindstrom J, Jacobsson M. Reconstruction of severely resorbed edentulous maxillae using osseointegrated fixtures in immediate autogenous bone grafts. Int J Oral Maxillofac Implants. 1990 Fall;5(3):233-46.

    PubMed 2098327

  • Nedir R, Bischof M, Briaux JM, Beyer S, Szmukler-Moncler S, Bernard JP. A 7-year life table analysis from a prospective study on ITI implants with special emphasis on the use of short implants. Results from a private practice. Clin Oral Implants Res. 2004 Apr;15(2):150-7. doi: 10.1111/j.1600-0501.2004.00978.x.

    PubMed 15085870

  • Urban IA, Nagursky H, Lozada JL, Nagy K. Horizontal ridge augmentation with a collagen membrane and a combination of particulated autogenous bone and anorganic bovine bone-derived mineral: a prospective case series in 25 patients. Int J Periodontics Restorative Dent. 2013 May-Jun;33(3):299-307. doi: 10.11607/prd.1407.

    PubMed 23593623

  • Menoni A, Bernardello F, Spinato S, Zaffe D. Full-arch vertical reconstruction of an extremely atrophic mandible with "box technique". A novel surgical procedure: a clinical and histologic case report. Implant Dent. 2013 Feb;22(1):2-7. doi: 10.1097/ID.0b013e318278fa1c.

    PubMed 23287979

  • Khoury, F. and Khoury, C.H., 2007. Mandibular bone block grafts: diagnosis, instrumentation, harvesting techniques and surgical procedures. In Bone augmentation in oral implantology. Quintessence, Berlin.

  • Misch CM. Comparison of intraoral donor sites for onlay grafting prior to implant placement. Int J Oral Maxillofac Implants. 1997 Nov-Dec;12(6):767-76.

    PubMed 9425757

  • Simion M, Baldoni M, Zaffe D. Jawbone enlargement using immediate implant placement associated with a split-crest technique and guided tissue regeneration. Int J Periodontics Restorative Dent. 1992;12(6):462-73.

    PubMed 1298734

  • Takahashi T, Funaki K, Shintani H, Haruoka T. Use of horizontal alveolar distraction osteogenesis for implant placement in a narrow alveolar ridge: a case report. Int J Oral Maxillofac Implants. 2004 Mar-Apr;19(2):291-4.

    PubMed 15101603

Questions about this trial

What is this clinical trial studying?

A study testing Expansion in people with Missing Maxillary Premolar, run by Cairo University.

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 4 inclusion and 6 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 3 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

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 Ahmed H Mahmoud (00201001029723, ahmedhish14@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

implant's primary stability (time frame: intraoperative at time of surgery). The study lists 5 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 NCT03613415, which also lists 32 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 3 Aug 2018.

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