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Alveolar Bone LossNCT04414709

Evaluation of Short Implants' Success for Teeth Replacement in Atrophic Posterior Mandibular Ridge

A study testing Double short implant and Single short implant in people with Alveolar Bone Loss, run by Alexandria University at 1 site in Egypt.

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 study was to evaluate clinically and radiographically the splinted short implants' and single short implants' stability and bone condition before and after loading, in atrophic posterior mandibular alveolar ridges. Read more about this study

Who is it for?
Ages 30 to 60 years
Conditions the study is for
Alveolar Bone Loss
What is being tested?
Double short implant and Single short implant
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteEgypt
Study dates
14 Apr 2019to 20 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 30 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Missing Posterior teeth, indicated for short implant placement.
  • Residual alveolar ridge at 6-8 mm height and at least 7mm width.
  • Healthy band of keratinized attached mucosa.
  • Good Oral hygiene.
  • Medically fit patient, free from relevant diseases.

Who cannot join

  • Medically compromised patients.
  • Imunnocompromised patients
  • Patients with Para-functional habits.
  • Smokers
  • Poor Oral hygiene.
  • Patient refuse to undergo the surgery.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Faculty of Dentistry, Alexandria University

    Alexandria, 21527

Other trials in Egypt

About this study

Official title: Evaluation of Short Implants' Success for Teeth Replacement in Atrophic Posterior Mandibular Ridge (A Clinical Trial)

The aim of this study was to evaluate clinically and radiographically the splinted short implants' and single short implants' stability and bone condition before and after loading, in atrophic posterior mandibular alveolar ridges.

Read the detailed description

A prospective study was conducted on 16 Patients with missing posterior molars. Group A: 8 patients had 2 short implants placed in atrophic posterior mandibular alveolar ridge. Group B: 8 patients had a single short implant placed in atrophic posterior mandibular alveolar ridge.

Being tested
Double short implant, Single short implant
Keywords
Short implant, Splinted short implant
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.

  • Double short implantOther

    Patients receives 2 short implants to restore missing posterior teeth, loaded with splinted screw retained crowns.

  • Single short implantOther

    Patients receives single short implants, loaded with single screw retained crowns.

Study groups in NCT04414709
Study groupRoleWhat they receive
Two short implantsExperimentalDENTIUM superline implant fixture is characterized by sandblasted with large grits and acid etched surface treatment (S.L.A). SLA surface allows good bone-implant contact with good clinical performance, maintaining crestal bone margin. Short Implants of 7.0 mm length and 4.5 mm diameter are to be used. The Short Implants are characterized by 1.5mm supra-bony smooth collar, and 5.5mm infra-bony surface treated double threaded titanium.
Receives: Other: Double short implant
Single short implantActive comparatorDENTIUM superline implant fixture is characterized by sandblasted with large grits and acid etched surface treatment (S.L.A). SLA surface allows good bone-implant contact with good clinical performance, maintaining crestal bone margin. Short Implants of 7.0 mm length and 4.5 mm diameter are to be used. The Short Implants are characterized by 1.5mm supra-bony smooth collar, and 5.5mm infra-bony surface treated double threaded titanium.
Receives: Other: Single short implant

What is being measured

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

  1. Implant Stability

    Implant stability was measured using Implant Stability Quotient (ISQ), a scale from 1 to 100. The ISQ scale has a non-linear correlation to micro-mobility. High stability means >70 ISQ, between 60-69 is medium stability and < 60 ISQ is considered as low stability.

    Measured: Immediately after the operation

  2. Implant Stability

    Implant stability was measured using Implant Stability Quotient (ISQ), a scale from 1 to 100. The ISQ scale has a non-linear correlation to micro-mobility. High stability means >70 ISQ, between 60-69 is medium stability and < 60 ISQ is considered as low stability.

    Measured: 3 months

  3. Implant Stability

    Implant stability was measured using Implant Stability Quotient (ISQ), a scale from 1 to 100. The ISQ scale has a non-linear correlation to micro-mobility. High stability means >70 ISQ, between 60-69 is medium stability and < 60 ISQ is considered as low stability.

    Measured: 6 months

Timeline

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

  1. First posted4 Jun 2020
  2. Study start14 Apr 2019
  3. Primary completion20 Jan 2020
  4. Study completion20 Feb 2020

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
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04414709
Sponsor's protocol ID
IORG 0008839
Status last verified
May 2020
First submitted
30 May 2020
Last updated
4 Jun 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Glantz PO, Nilner K. Biomechanical aspects of prosthetic implant-borne reconstructions. Periodontol 2000. 1998 Jun;17:119-24. doi: 10.1111/j.1600-0757.1998.tb00129.x. No abstract available.

    PubMed 10337319

  • Renouard F, Nisand D. Short implants in the severely resorbed maxilla: a 2-year retrospective clinical study. Clin Implant Dent Relat Res. 2005;7 Suppl 1:S104-10. doi: 10.1111/j.1708-8208.2005.tb00082.x.

    PubMed 16137095

  • Tallgren A. The reduction in face height of edentulous and partially edentulous subjects during long-term denture wear. A longitudinal roentgenographic cephalometric study. Acta Odontol Scand. 1966 Sep;24(2):195-239. doi: 10.3109/00016356609026127. No abstract available.

    PubMed 5225747

  • Nevins M, Al Hezaimi K, Schupbach P, Karimbux N, Kim DM. Vertical ridge augmentation using an equine bone and collagen block infused with recombinant human platelet-derived growth factor-BB: a randomized single-masked histologic study in non-human primates. J Periodontol. 2012 Jul;83(7):878-84. doi: 10.1902/jop.2012.110478. Epub 2012 Jan 5.

    PubMed 22220770

  • Chiapasco M, Casentini P, Zaniboni M. Bone augmentation procedures in implant dentistry. Int J Oral Maxillofac Implants. 2009;24 Suppl:237-59.

    PubMed 19885448

  • das Neves FD, Fones D, Bernardes SR, do Prado CJ, Neto AJ. Short implants--an analysis of longitudinal studies. Int J Oral Maxillofac Implants. 2006 Jan-Feb;21(1):86-93.

    PubMed 16519186

  • Neldam CA, Pinholt EM. State of the art of short dental implants: a systematic review of the literature. Clin Implant Dent Relat Res. 2012 Aug;14(4):622-32. doi: 10.1111/j.1708-8208.2010.00303.x. Epub 2010 Oct 26.

    PubMed 20977606

  • Thoma DS, Haas R, Tutak M, Garcia A, Schincaglia GP, Hammerle CH. Randomized controlled multicentre study comparing short dental implants (6 mm) versus longer dental implants (11-15 mm) in combination with sinus floor elevation procedures. Part 1: demographics and patient-reported outcomes at 1 year of loading. J Clin Periodontol. 2015 Jan;42(1):72-80. doi: 10.1111/jcpe.12323. Epub 2014 Dec 26.

    PubMed 25418606

  • Lemos CA, Ferro-Alves ML, Okamoto R, Mendonca MR, Pellizzer EP. Short dental implants versus standard dental implants placed in the posterior jaws: A systematic review and meta-analysis. J Dent. 2016 Apr;47:8-17. doi: 10.1016/j.jdent.2016.01.005. Epub 2016 Jan 19.

    PubMed 26804969

  • Misch CE, Steignga J, Barboza E, Misch-Dietsh F, Cianciola LJ, Kazor C. Short dental implants in posterior partial edentulism: a multicenter retrospective 6-year case series study. J Periodontol. 2006 Aug;77(8):1340-7. doi: 10.1902/jop.2006.050402.

    PubMed 16937587

  • Menchero-Cantalejo E, Barona-Dorado C, Cantero-Alvarez M, Fernandez-Caliz F, Martinez-Gonzalez JM. Meta-analysis on the survival of short implants. Med Oral Patol Oral Cir Bucal. 2011 Jul 1;16(4):e546-51. doi: 10.4317/medoral.16.e546.

    PubMed 21196883

  • Lum LB. A biomechanical rationale for the use of short implants. J Oral Implantol. 1991;17(2):126-31.

    PubMed 1811063

Questions about this trial

What is this clinical trial studying?

A study testing Double short implant and Single short implant in people with Alveolar Bone Loss, run by Alexandria University at 1 site in Egypt.

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 5 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: finished, as of the sponsor's last update on 4 Jun 2020. 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 Egypt. 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?

Implant Stability (time frame: Immediately after the operation). The study lists 3 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 NCT04414709, 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 4 Jun 2020.

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