Short vs Long Dental Implants for the Fixed Rehabilitation of the Fully Edentulous Mandible

NCT03509402 | Completed Results

• 1 other identifier: CEAOUSUN1327012010
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to clinically and radiographically compare the performance of short (6 mm-long) versus long (≥11 mm-long) dental implants placed in the interforaminal region of fully edentulous mandibles, supporting a screw-retained full-arch cantilever bridge.

Conditions

Edentulous Jaw

Keywords

short dental implants; full-arch prosthesis

Outcome Measures

Primary Outcomes (1)

• Marginal Bone Level (MBL) Change

  Marginal bone level (MBL) is measured as the distance in millimiters calculated on periapical radiographs from the implant neck to the most coronal bone-to-implant contact point at both the mesial and the distal side of each implant. The radiographs will be taken with an X-ray apparatus supplied with a long cone and Rinn's film holders.

  5 years from baseline (prosthetic loading)

Secondary Outcomes (4)

• Implant Survival Rate

  5 years from baseline (prosthetic loading)

• Prosthesis Survival

  5 years from baseline (prosthetic loading)

• Biological Complications

  5 years from baseline (prosthetic loading)

• Technical Complications

  5 years from baseline (prosthetic loading)

Study Arms (2)

Short implants

EXPERIMENTAL

A full-arch screw-retained mandibular prosthesis with distal cantilevers supported by five interforaminal short implants (ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: 6mm)

Device: ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: 6 mm

Long implants

ACTIVE COMPARATOR

A full-arch srew-retained mandibular prosthesis with distal cantilevers supported by five interforaminal short implants (ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: ≥11mm)

Device: ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: ≥11mm

Interventions

ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: 6 mm DEVICE

Rehabilitation of the edentulous mandible by a full-arch srew-retained prosthesis with distal cantilevers supported by five interforaminal short implants (ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: 6 mm)

Short implants

ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: ≥11mm DEVICE

Rehabilitation of the edentulous mandible by a full-arch srew-retained prosthesis with distal cantilevers supported by five interforaminal long implants (ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: ≥11mm)

Long implants

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• total edentulous patients in the lower region since at least 8 months,
• sufficient amount of native bone (no augmentation procedures) in the recipient sites to allow ≥11 mm long and 4 mm wide implant installation (≥1 mm of peri-implant bone circumferentially)
• systemic health
• compliance with good oral hygiene
• informed consent signed.

You may not qualify if:

• any disease, medication or drug that could jeopardize healing, osseointegration or treatment outcome,
• untreated caries or periodontitis of the remaining teeth,
• mucosal and bone tissue lesions,
• severe bruxism or other parafunction habits,
• unrealistic aesthetic demands,
• patient taking part to another study

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead
• Dentsply Sirona Implants and Consumables: collaborator

Related Publications (7)

• Albrektsson T, Zarb G, Worthington P, Eriksson AR. The long-term efficacy of currently used dental implants: a review and proposed criteria of success. Int J Oral Maxillofac Implants. 1986 Summer;1(1):11-25. No abstract available.

  PMID: 3527955 BACKGROUND

• Nisand D, Renouard F. Short implant in limited bone volume. Periodontol 2000. 2014 Oct;66(1):72-96. doi: 10.1111/prd.12053.

  PMID: 25123762 BACKGROUND

• Ekelund JA, Lindquist LW, Carlsson GE, Jemt T. Implant treatment in the edentulous mandible: a prospective study on Branemark system implants over more than 20 years. Int J Prosthodont. 2003 Nov-Dec;16(6):602-8.

  PMID: 14714838 BACKGROUND

• Srinivasan M, Vazquez L, Rieder P, Moraguez O, Bernard JP, Belser UC. Survival rates of short (6 mm) micro-rough surface implants: a review of literature and meta-analysis. Clin Oral Implants Res. 2014 May;25(5):539-45. doi: 10.1111/clr.12125. Epub 2013 Feb 18.

  PMID: 23413956 BACKGROUND

• Laurell L, Lundgren D. Marginal bone level changes at dental implants after 5 years in function: a meta-analysis. Clin Implant Dent Relat Res. 2011 Mar;13(1):19-28. doi: 10.1111/j.1708-8208.2009.00182.x.

  PMID: 19681932 BACKGROUND

• Guida L, Annunziata M, Esposito U, Sirignano M, Torrisi P, Cecchinato D. 6-mm-short and 11-mm-long implants compared in the full-arch rehabilitation of the edentulous mandible: A 3-year multicenter randomized controlled trial. Clin Oral Implants Res. 2020 Jan;31(1):64-73. doi: 10.1111/clr.13547. Epub 2019 Oct 29.

  PMID: 31605405 RESULT

• Guida L, Esposito U, Sirignano M, Torrisi P, Annunziata M, Cecchinato D. 6 mm short versus 11 mm long inter-foraminal implants in the full-arch rehabilitation of edentulous non-atrophic mandibles: 5-year results from a multicenter randomized controlled trial. Clin Oral Implants Res. 2023 Feb;34(2):127-136. doi: 10.1111/clr.14024. Epub 2022 Dec 13.

  PMID: 36461704 RESULT

MeSH Terms

Conditions

Jaw, Edentulous

Condition Hierarchy (Ancestors)

Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth Diseases

Results Point of Contact

• Title: Prof. Marco Annunziata
• Organization: University of Campania "Luigi Vanvitelli"

marco.annunziata@unicampania.it

0815665515

Study Officials

• Luigi Guida, Prof

  University of Campania Luigi Vanvitelli

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: March 31, 2018
• First Posted: April 26, 2018
• Study Start: January 1, 2010
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: January 13, 2025
• Results First Posted: January 13, 2025

Record last verified: 2024-11