NCT04414709

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 14, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 4, 2020

Completed
Last Updated

June 4, 2020

Status Verified

May 1, 2020

Enrollment Period

9 months

First QC Date

May 30, 2020

Last Update Submit

May 30, 2020

Conditions

Alveolar Bone Loss

Keywords

Short implantSplinted short implant

Outcome Measures

Primary Outcomes (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.

    Immediately after the operation

  • 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.

    3 months

  • 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.

    6 months

Study Arms (2)

Two short implants

EXPERIMENTAL

DENTIUM 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.

Other: Double short implant

Single short implant

ACTIVE COMPARATOR

DENTIUM 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.

Other: Single short implant

Interventions

Double short implantOTHER

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

Two short implants
Single short implantOTHER

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

Single short implant

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, 21527, Egypt

Location

Related Publications (12)

  • 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.

    PMID: 10337319BACKGROUND

  • 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.

    PMID: 16137095BACKGROUND

  • 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.

    PMID: 5225747BACKGROUND

  • 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.

    PMID: 22220770BACKGROUND

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

    PMID: 19885448BACKGROUND

  • 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.

    PMID: 16519186BACKGROUND

  • 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.

    PMID: 20977606BACKGROUND

  • 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.

    PMID: 25418606BACKGROUND

  • 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.

    PMID: 26804969BACKGROUND

  • 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.

    PMID: 16937587BACKGROUND

  • 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.

    PMID: 21196883BACKGROUND

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

    PMID: 1811063BACKGROUND

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Oral Surgery Master's student

Study Record Dates

First Submitted

May 30, 2020

First Posted

June 4, 2020

Study Start

April 14, 2019

Primary Completion

January 20, 2020

Study Completion

February 20, 2020

Last Updated

June 4, 2020

Record last verified: 2020-05

Locations

EG(1)