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CompletedNCT05284461Updated Mar 17, 2022

Effect of Shape and Surface Treatment of the Transmucosal Abutments on Peri-implant Health.

An interventional study of dental implant with transepithelial abutments manufactured by Galimplant Dental System (Spain) in Edentulous; Alveolar Process, Atrophy, sponsored by University of Salamanca. Completed at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-17.

Sponsored by University of Salamanca · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 9 months after the study started (first participant enrolled May 2020, registered Feb 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

The sample was comprised by 10 patients in which 40 dental implants are placed in an atrophic maxilla. All the implants were connected to 4 types of transepithelial abutment: i.e: parallel anodized abutment(n=10); parallel mechanized abutmen(n=10)t, convergent anodized abutment(n=10); and convergent mechanized abutment (n=10) three months after insertion implants were extracted with the surrounding hard and soft tissues for the histological evaluation of the clinical performance.

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Conditions studied

  • Edentulous; Alveolar Process, Atrophy

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03

In context

Atrophy

828 studies on the registry are indexed under Atrophy; 122 are open to participants now.

This study's enrollment of 10 is below the median of 34 across 603 interventional studies indexed under Atrophy.

Browse Atrophy studies →

Lead sponsor

University of Salamanca is the lead sponsor of 110 studies on the registry; 48 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 and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • totally edentulous patients in the upper arch and carriers of conventional complete dentures for more than ten years, without temporomandibular disorders

Exclusion criteria

Exclusion Criteria:

  • evidence of systemic or psychic pathology that contraindicates implant treatment.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
10 participants (actual)

Study arms

  • Placebo comparator
    Mechanized parallel abutments

    Implants were immediately covered with this type of abutments after insertion. This is the most common procedure. It would be the gold standard

    Device: dental implant with transepithelial abutments manufactured by Galimplant Dental System (Spain)

  • Experimental
    Anodized parallel abutments

    Implants were immediately covered with this kind of abutments after insertion. Only the surface treatment varies to the gold standard

    Device: dental implant with transepithelial abutments manufactured by Galimplant Dental System (Spain)

  • Experimental
    Mechanized convergent abutments

    Implants were immediately covered with this kind of abutments after insertion. Only the geometry of the emergence profile varies with regards to the gold standard

    Device: dental implant with transepithelial abutments manufactured by Galimplant Dental System (Spain)

  • Experimental
    Anodized convergent abutments

    Implants were immediately covered with this kind of abutments after insertion. Both the surface treatment and the geometry vary with regards to the gold standard

    Device: dental implant with transepithelial abutments manufactured by Galimplant Dental System (Spain)

Interventions

  • Devicedental implant with transepithelial abutments manufactured by Galimplant Dental System (Spain)

    Dental implants with transepithelial abutments with distinct morphology

06

What researchers measure

Primary outcomes

  1. Bone to implant contact

    It is a Percentage estimation of native bone in direct contact to implant determined by histological assessments (optical microscopy)

    Time frame: 3 months after healing

  2. Peri-implant inflammation of the soft tissues

    Histological assessments as ordinal variables of the grade of inflammatory infiltrate (none, minor, major)according to standard guidelines.

    Time frame: 3 months after healing

  3. Density of the peri-implant soft tissues

    Histological assessments as ordinal variables of the density of the collagen fibers (low, medium, high) according to standard guidelines.

    Time frame: 3 months after healing

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Study locations

1 site
  • Clinica Odontológica de la Universidad de Salamanca
    Salamanca, 37007, Spain
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2022, 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
NCT05284461
Lead sponsor
University of Salamanca
Responsible party
JAVIER MONTERO (Professor in Prosthodontics, University of Salamanca) — Principal investigator
First posted
Mar 17, 2022
Start date
May 1, 2020
Primary completion
Jan 1, 2021
Completion
Sep 1, 2021
Last update
Mar 17, 2022

Oversight

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

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This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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