NCT05284461

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

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

May 1, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 17, 2022

Completed
Last Updated

March 17, 2022

Status Verified

February 1, 2022

Enrollment Period

8 months

First QC Date

February 2, 2022

Last Update Submit

March 8, 2022

Conditions

Edentulous; Alveolar Process, Atrophy

Outcome Measures

Primary Outcomes (3)

  • Bone to implant contact

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

    3 months after healing

  • 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.

    3 months after healing

  • 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.

    3 months after healing

Study Arms (4)

Mechanized parallel abutments

PLACEBO COMPARATOR

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)

Anodized parallel abutments

EXPERIMENTAL

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)

Mechanized convergent abutments

EXPERIMENTAL

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)

Anodized convergent abutments

EXPERIMENTAL

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

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

Dental implants with transepithelial abutments with distinct morphology

Anodized convergent abutmentsAnodized parallel abutmentsMechanized convergent abutmentsMechanized parallel abutments

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica Odontológica de la Universidad de Salamanca

Salamanca, 37007, Spain

Location

MeSH Terms

Conditions

Mouth, EdentulousAtrophy

Interventions

Dental Implants

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesTooth DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dental MaterialsBiomedical and Dental MaterialsDental ProsthesisProsthodonticsDentistryProstheses and ImplantsEquipment and SuppliesManufactured MaterialsTechnology, Industry, and Agriculture

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Prosthodontics

Study Record Dates

First Submitted

February 2, 2022

First Posted

March 17, 2022

Study Start

May 1, 2020

Primary Completion

January 1, 2021

Study Completion

September 1, 2021

Last Updated

March 17, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)