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

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Double short implant

Single short implant

About this trial

This is an interventional treatment trial for Alveolar Bone Loss focused on measuring Short implant, Splinted short implant

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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

Sites / Locations

Faculty of Dentistry, Alexandria University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Two short implants

Single short implant

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04414709

First Posted

May 30, 2020

Last Updated

May 30, 2020

Sponsor

Alexandria University

1. Study Identification

Unique Protocol Identification Number

NCT04414709

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Completed

Study Start Date

April 14, 2019 (Actual)

Primary Completion Date

January 20, 2020 (Actual)

Study Completion Date

February 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alveolar Bone Loss

Keywords

Short implant, Splinted short implant

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Two short implants

Arm Type

Experimental

Arm Description

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.

Arm Title

Single short implant

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Double short implant

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Single short implant

Intervention Description

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

Primary Outcome Measure Information:

Title

Implant Stability

Description

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.

Time Frame

Immediately after the operation

Title

Implant Stability

Description

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.

Time Frame

3 months

Title

Implant Stability

Description

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.

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Facility Information:

Facility Name

Faculty of Dentistry, Alexandria University

City

Alexandria

ZIP/Postal Code

21527

Country

Egypt

12. IPD Sharing Statement

Citations:

PubMed Identifier

10337319

Citation

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.

Results Reference

background

PubMed Identifier

16137095

Citation

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.

Results Reference

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PubMed Identifier

5225747

Citation

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.

Results Reference

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PubMed Identifier

22220770

Citation

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.

Results Reference

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PubMed Identifier

19885448

Citation

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

Results Reference

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PubMed Identifier

16519186

Citation

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.

Results Reference

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PubMed Identifier

20977606

Citation

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.

Results Reference

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PubMed Identifier

25418606

Citation

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.

Results Reference

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PubMed Identifier

26804969

Citation

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.

Results Reference

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PubMed Identifier

16937587

Citation

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.

Results Reference

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PubMed Identifier

21196883

Citation

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.

Results Reference

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PubMed Identifier

1811063

Citation

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

Results Reference

background

Alveolar Bone Loss

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial