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Completed

NCT Number: NCT05284461

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

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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Key information

Conditions

Edentulous; Alveolar Process, Atrophy Atrophy Mouth Diseases Mouth, Edentulous Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Stomatognathic Diseases Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinica Odontológica de la Universidad de Salamanca

Salamanca, 37007, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

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

Device

Dental implants with transepithelial abutments with distinct morphology

Primary outcomes

  1. Bone to implant contact

    Time frame: 3 months after healing

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

  2. Peri-implant inflammation of the soft tissues

    Time frame: 3 months after healing

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

  3. Density of the peri-implant soft tissues

    Time frame: 3 months after healing

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

Sponsors and collaborators

Lead sponsor

University of Salamanca

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 17, 2022
Registry last updated
Mar 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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