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SuspendedNCT05883202Updated May 12, 2026

Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental Implants

An interventional study of Connect® and Multi-unit in Jaw, Edentulous, Partially, sponsored by Universidad de Granada. Suspended at 1 site in Spain. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-12.

Sponsored by Universidad de Granada · Not applicable, Interventional, and Treatment

Why this study was suspended
No researcher available to conduct the study.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
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Study 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.

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Conditions studied

  • Jaw, Edentulous, Partially
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In context

Jaw, Edentulous, Partially

66 studies on the registry are indexed under Jaw, Edentulous, Partially; 7 are open to participants now.

This study's planned enrollment of 40 is above the median of 36 across 58 interventional studies indexed under Jaw, Edentulous, Partially.

Browse Jaw, Edentulous, Partially studies →

Lead sponsor

Universidad de Granada is the lead sponsor of 241 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion criteria:

  • 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.
  • Long-term (>3 months) history of antibiotics or drugs known to alter the inflammation and/or immunological system 3 months before inclusion.
  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Connect®

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

    Device: Connect®

  • Active comparator
    Multi-unit

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

    Device: Multi-unit

Interventions

  • DeviceConnect®

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

  • DeviceMulti-unit

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

06

What researchers measure

Primary outcomes

  1. Marginal bone level

    Peri-implant marginal bone level measured by standardized periapical radiography

    Time frame: 1 year

Secondary outcomes

  1. Peri-implant microbiome

    Relative abundance of microbial species in the peri-implant sulcus evaluated by next-generation sequencing methods

    Time frame: 1 year

  2. Peri-implant inflammation

    Concentration of pro-inflammatory markers in the peri-implant sulcus evaluated by multiplex techniques methods

    Time frame: 1 year

Other outcomes

  1. Soft-tissue volume

    Three-dimensional volume of the soft tissue around the implants

    Time frame: 1 year

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Study locations

1 site
  • Universidad de Granada
    Granada, Granada 18071, Spain
08

References and documents

Publications

  • 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. PubMed 24621670 ↗
  • 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. PubMed 32865627 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05883202
Lead sponsor
Universidad de Granada
Responsible party
Miguel Padial-Molina (Associate Professor, Universidad de Granada) — Principal investigator
First posted
May 31, 2023
Start date
Jul 10, 2023
Primary completion
May 2026 (estimated)
Completion
Jul 2026 (estimated)
Last update
May 12, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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