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

Primary Purpose

Edentulous; Alveolar Process, Atrophy

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
dental implant with transepithelial abutments manufactured by Galimplant Dental System (Spain)
Sponsored by
University of Salamanca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Edentulous; Alveolar Process, Atrophy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Clinica Odontológica de la Universidad de Salamanca

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Mechanized parallel abutments

Anodized parallel abutments

Mechanized convergent abutments

Anodized convergent abutments

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 2, 2022
Last Updated
March 8, 2022
Sponsor
University of Salamanca
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1. Study Identification

Unique Protocol Identification Number
NCT05284461
Brief Title
Effect of Shape and Surface Treatment of the Transmucosal Abutments on Peri-implant Health.
Official Title
Effect of Shape and Surface Treatment of the Transmucosal Abutments on the Bone-implant-contact and the Peri-implant Health, .
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
September 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Salamanca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edentulous; Alveolar Process, Atrophy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mechanized parallel abutments
Arm Type
Placebo Comparator
Arm Description
Implants were immediately covered with this type of abutments after insertion. This is the most common procedure. It would be the gold standard
Arm Title
Anodized parallel abutments
Arm Type
Experimental
Arm Description
Implants were immediately covered with this kind of abutments after insertion. Only the surface treatment varies to the gold standard
Arm Title
Mechanized convergent abutments
Arm Type
Experimental
Arm Description
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
Arm Title
Anodized convergent abutments
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
dental implant with transepithelial abutments manufactured by Galimplant Dental System (Spain)
Intervention Description
Dental implants with transepithelial abutments with distinct morphology
Primary Outcome Measure Information:
Title
Bone to implant contact
Description
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
Title
Peri-implant inflammation of the soft tissues
Description
Histological assessments as ordinal variables of the grade of inflammatory infiltrate (none, minor, major)according to standard guidelines.
Time Frame
3 months after healing
Title
Density of the peri-implant soft tissues
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Clinica Odontológica de la Universidad de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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