NCT05712031

Brief Summary

The goal of this clinical study is to evaluate clinical performance of combined tooth-implant supported 3 unit fixed partial dentures in the posterior mandible and was to compare and evaluate them with the complications of 3 unit fixed partial dentures supported with free standing dental implants.The main question\[s\] it aims to answer are: 1.Is there any difference in terms of mechanical and biological complications as well as marginal bone level between free standing and combined tooth-implant supported 3 unit Fixed Partial Dentures in posterior mandible. Participants will receive either 2 dental implants(Control group) or 1 standart length dental implants to be combine with abutment tooth or 1 short dental implant to be combine with abutment tooth for supporting 3 unit fixed partial dentures.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2015

Longer than P75 for not_applicable

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

July 3, 2015

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 3, 2023

Completed
Last Updated

February 3, 2023

Status Verified

January 1, 2023

Enrollment Period

6.9 years

First QC Date

January 14, 2023

Last Update Submit

January 25, 2023

Conditions

Dental ImplantShort Dental Implant

Outcome Measures

Primary Outcomes (8)

  • Marginal bone loss

    Mesial and distal marginal bone loss around dental implants is measured by periodical radiographs

    At baseline

  • Marginal bone loss

    Mesial and distal marginal bone loss around dental implants is measured by periodical radiographs

    6 months

  • Marginal bone loss

    Mesial and distal marginal bone loss around dental implants is measured by periodical radiographs

    1 year

  • Marginal bone loss

    Mesial and distal marginal bone loss around dental implants is measured by periodical radiographs

    2 years

  • Marginal bone loss

    Mesial and distal marginal bone loss around dental implants is measured by periodical radiographs

    3 years

  • Marginal bone loss

    Mesial and distal marginal bone loss around dental implants is measured by periodical radiographs

    4 years

  • Marginal bone loss

    Mesial and distal marginal bone loss around dental implants is measured by periodical radiographs

    5 years

  • Marginal bone loss

    Mesial and distal marginal bone loss around dental implants is measured by periodical radiographs

    6 years

Secondary Outcomes (16)

  • Modified gingival index

    At baseline

  • Modified gingival index

    6 months

  • Modified gingival index

    1 year

  • Modified gingival index

    2 years

  • Modified gingival index

    3 years

  • +11 more secondary outcomes

Study Arms (3)

Group2

EXPERIMENTAL

Mandibular first or second premolar is combined with standard length(8-12mm) dental implants to support 3 unit Fixed Partial Dentures

Procedure: Insertion of 1 Nucleoss T4 dental implants in posterior mandible

Group3

EXPERIMENTAL

Mandibular first or second premolar is combined with short dental implants(5-6mm) to support 3 unit Fixed Partial Dentures

Procedure: Insertion of 1 Nucleoss T5 dental implants in posterior mandible

Group1

ACTIVE COMPARATOR

Standard length (8-12mm) dental implants are inserted in posterior mandible replacing either first premolar and first molar or second premolar and second molar to support 3 unit fixed partial dentures.

Procedure: Insertion of 2 Nucleoss T4 dental implants posterior mandible

Interventions

Insertion of 1 Nucleoss T4 dental implants in posterior mandiblePROCEDURE

Nucleoss T4 dental implants is combined with first or second premolar to support 3 unit fixed partial dentures

Group2
Insertion of 1 Nucleoss T5 dental implants in posterior mandiblePROCEDURE

Nucleoss T5 dental implants is combined with first or second premolar to support 3 unit fixed partial dentures

Group3
Insertion of 2 Nucleoss T4 dental implants posterior mandiblePROCEDURE

2 freestanding Nucleoss T4 dental implants is used to support 3 unit fixed partial dentures

Group1

Eligibility Criteria

Age37 Years - 73 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with no systemic disorders,
  • Partial edentulous in the posterior mandible unilaterally or bilaterally with maxillary arch fully dentate or have teeth and/or implant supported FPD,
  • At least 3 months of healing after tooth extraction on implant site,
  • Periodontally and endodontically healthy abutment tooth to be combined with implant,
  • Patients who have good oral hygiene habits,
  • Patients smoking less than 10 cigarettes/day,
  • More than 2mm of keratinized gingiva on implant site

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (13)

  • Meffert RM, Langer B, Fritz ME. Dental implants: a review. J Periodontol. 1992 Nov;63(11):859-70. doi: 10.1902/jop.1992.63.11.859.

    PMID: 1453301BACKGROUND

  • Rameh S, Menhall A, Younes R. Key factors influencing short implant success. Oral Maxillofac Surg. 2020 Sep;24(3):263-275. doi: 10.1007/s10006-020-00841-y. Epub 2020 Apr 23.

    PMID: 32323043BACKGROUND

  • Zarb GA, Lewis DW. Dental implants and decision making. J Dent Educ. 1992 Dec;56(12):863-72.

    PMID: 1487588BACKGROUND

  • Al-Omiri MK, Al-Masri M, Alhijawi MM, Lynch E. Combined Implant and Tooth Support: An Up-to-Date Comprehensive Overview. Int J Dent. 2017;2017:6024565. doi: 10.1155/2017/6024565. Epub 2017 Mar 23.

    PMID: 28424733BACKGROUND

  • de Paula GA, Silva GC, Vilaca EL, Cornacchia TM, de Magalhaes CS, Moreira AN. Biomechanical Behavior of Tooth-Implant Supported Prostheses With Different Implant Connections: A Nonlinear Finite Element Analysis. Implant Dent. 2018 Jun;27(3):294-302. doi: 10.1097/ID.0000000000000737.

    PMID: 29521677BACKGROUND

  • Tsouknidas A, Giannopoulos D, Savvakis S, Michailidis N, Lympoudi E, Fytanidis D, Pissiotis A, Michalakis K. The Influence of Bone Quality on the Biomechanical Behavior of a Tooth-Implant Fixed Partial Denture: A Three-Dimensional Finite Element Analysis. Int J Oral Maxillofac Implants. 2016 Nov/Dec;31(6):e143-e154. doi: 10.11607/jomi.5254.

    PMID: 27861651BACKGROUND

  • Hosny M, Duyck J, van Steenberghe D, Naert I. Within-subject comparison between connected and nonconnected tooth-to-implant fixed partial prostheses: up to 14-year follow-up study. Int J Prosthodont. 2000 Jul-Aug;13(4):340-6.

    PMID: 11203652BACKGROUND

  • Naert IE, Duyck JA, Hosny MM, Van Steenberghe D. Freestanding and tooth-implant connected prostheses in the treatment of partially edentulous patients. Part I: An up to 15-years clinical evaluation. Clin Oral Implants Res. 2001 Jun;12(3):237-44. doi: 10.1034/j.1600-0501.2001.012003237.x.

    PMID: 11359481BACKGROUND

  • Gunne J, Astrand P, Lindh T, Borg K, Olsson M. Tooth-implant and implant supported fixed partial dentures: a 10-year report. Int J Prosthodont. 1999 May-Jun;12(3):216-21.

    PMID: 10635188BACKGROUND

  • Nickenig HJ, Schafer C, Spiekermann H. Survival and complication rates of combined tooth-implant-supported fixed partial dentures. Clin Oral Implants Res. 2006 Oct;17(5):506-11. doi: 10.1111/j.1600-0501.2006.01259.x.

    PMID: 16958689BACKGROUND

  • Schwartz SR. Short Implants: An Answer to a Challenging Dilemma? Dent Clin North Am. 2020 Apr;64(2):279-290. doi: 10.1016/j.cden.2019.11.001. Epub 2020 Jan 2.

    PMID: 32111268BACKGROUND

  • Benlidayi ME, Ucar Y, Tatli U, Ekren O, Evlice B, Kisa HI, Baksi U. Short Implants Versus Standard Implants: Midterm Outcomes of a Clinical Study. Implant Dent. 2018 Feb;27(1):95-100. doi: 10.1097/ID.0000000000000710.

    PMID: 29303816BACKGROUND

  • Jung RE, Al-Nawas B, Araujo M, Avila-Ortiz G, Barter S, Brodala N, Chappuis V, Chen B, De Souza A, Almeida RF, Fickl S, Finelle G, Ganeles J, Gholami H, Hammerle C, Jensen S, Jokstad A, Katsuyama H, Kleinheinz J, Kunavisarut C, Mardas N, Monje A, Papaspyridakos P, Payer M, Schiegnitz E, Smeets R, Stefanini M, Ten Bruggenkate C, Vazouras K, Weber HP, Weingart D, Windisch P. Group 1 ITI Consensus Report: The influence of implant length and design and medications on clinical and patient-reported outcomes. Clin Oral Implants Res. 2018 Oct;29 Suppl 16:69-77. doi: 10.1111/clr.13342.

    PMID: 30328189BACKGROUND

Study Officials

  • ORHUN EKREN, PhD

    Cukurova University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 14, 2023

First Posted

February 3, 2023

Study Start

July 3, 2015

Primary Completion

June 6, 2022

Study Completion

September 9, 2022

Last Updated

February 3, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share