NCT05883202

Brief Summary

In dental implant restoration, available literature demonstrates the advantage of using tall abutments, with a change of diameter with respect to the implant and a conical internal connection in the abutment-implant gap. However, for multiple restorations, the abutment-prosthesis connection has not been studied in detail. The "multi-unit" systems, both standard and brand specific, have either a flat or butt joint or an cone. In any case, both are external connection systems. Recently, an internal-type abutment-prosthesis connection system has been developed. Although it is proving its usefulness in single restorations, its use in multiple restorations compared to traditional systems has not been studied. Therefore, taking into account all of the above, the present study has the overall objective of analyzing marginal bone loss (MBL) and adaptation of soft tissues by comparing a multiple prosthesis system of the "external, flat" type versus an external system of the "internal, conical" type.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Jul 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress95%
Jul 2023Jul 2026

First Submitted

Initial submission to the registry

May 20, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 31, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

July 10, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

December 5, 2024

Status Verified

December 1, 2024

Enrollment Period

2.8 years

First QC Date

May 20, 2023

Last Update Submit

December 3, 2024

Conditions

Jaw, Edentulous, Partially

Outcome Measures

Primary Outcomes (1)

  • Marginal bone level

    Peri-implant marginal bone level measured by standardized periapical radiography

    1 year

Secondary Outcomes (2)

  • Peri-implant microbiome

    1 year

  • Peri-implant inflammation

    1 year

Other Outcomes (1)

  • Soft-tissue volume

    1 year

Study Arms (2)

Connect®

EXPERIMENTAL

Restoration of multiple implants with a Connect® abutment between the implant and the prosthesis.

Device: Connect®

Multi-unit

ACTIVE COMPARATOR

Restoration of multiple implants with a conventional multi-unit abutment between the implant and the prosthesis.

Device: Multi-unit

Interventions

Connect®DEVICE

Restoration of multiple implants with a Connect® abutment between the implant and the prosthesis.

Connect®
Multi-unitDEVICE

Restoration of multiple implants with a conventional multi-unit abutment between the implant and the prosthesis.

Multi-unit

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Kennedy class I or II (unilateral or bilateral free end) or III (posterior intermediate edentulous section) mandibular requiring 2 implants to restore at least 2 molars, 2 molars and 1 premolar, or 2 premolars and 1 molar.
  • Possibility of placing a transgingival abutment at least 2 mm high.

You may not qualify if:

  • Need for simultaneous bone augmentation.
  • Heavy smokers (\>10 cigarettes/day).
  • Uncontrolled type 1 or 2 diabetes (HgA1c\>8).
  • Known autoimmune or inflammatory disease.
  • Serious blood disorders, such as hemophilia or leukemia.
  • Local or systemic infection that may compromise normal healing (e.g., extensive periapical pathology).
  • Liver or kidney dysfunction/failure.
  • Currently receiving cancer treatment or within 18 months from completion of radio- or chemotherapy.
  • Long-term history of oral bisphosphonates use (i.e., 10 years or more).
  • History of intravenous bisphosphonates.
  • Severe osseous diseases (e.g., Paget disease of bone).
  • Pregnant women or nursing mothers.
  • Not able or not willing to follow instructions related to the study procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de Granada

Granada, 18071, Spain

Location

Related Publications (2)

  • Galindo-Moreno P, Leon-Cano A, Ortega-Oller I, Monje A, Suarez F, OValle F, Spinato S, Catena A. Prosthetic Abutment Height is a Key Factor in Peri-implant Marginal Bone Loss. J Dent Res. 2014 Jul;93(7 Suppl):80S-85S. doi: 10.1177/0022034513519800. Epub 2014 Mar 12.

    PMID: 24621670BACKGROUND

  • Couso-Queiruga E, Tattan M, Ahmad U, Barwacz C, Gonzalez-Martin O, Avila-Ortiz G. Assessment of gingival thickness using digital file superimposition versus direct clinical measurements. Clin Oral Investig. 2021 Apr;25(4):2353-2361. doi: 10.1007/s00784-020-03558-0. Epub 2020 Aug 31.

    PMID: 32865627BACKGROUND

MeSH Terms

Conditions

Jaw, Edentulous, Partially

Condition Hierarchy (Ancestors)

Jaw, EdentulousJaw DiseasesMusculoskeletal DiseasesStomatognathic DiseasesMouth, EdentulousMouth DiseasesTooth Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 20, 2023

First Posted

May 31, 2023

Study Start

July 10, 2023

Primary Completion

May 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

December 5, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)