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

Sponsor

University of Salamanca (Other)

Overall Status

Completed

CT.gov ID

NCT05284461

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Edentulous; Alveolar Process, Atrophy	Device: dental implant with transepithelial abutments manufactured by Galimplant Dental System (Spain)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 1, 2020

Actual Primary Completion Date :

Jan 1, 2021

Actual Study Completion Date :

Sep 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
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) Dental implants with transepithelial abutments with distinct morphology
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) Dental implants with transepithelial abutments with distinct morphology
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) Dental implants with transepithelial abutments with distinct morphology
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) Dental implants with transepithelial abutments with distinct morphology

Outcome Measures

Primary Outcome Measures

Bone to implant contact [3 months after healing]
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 [3 months after healing]
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 [3 months after healing]
Histological assessments as ordinal variables of the density of the collagen fibers (low, medium, high) according to standard guidelines.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

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:

evidence of systemic or psychic pathology that contraindicates implant treatment.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinica Odontológica de la Universidad de Salamanca	Salamanca		Spain	37007

Sponsors and Collaborators

University of Salamanca

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

JAVIER MONTERO, Professor in Prosthodontics, University of Salamanca

ClinicalTrials.gov Identifier:

NCT05284461

Other Study ID Numbers:

USAL_2021_JMONT

First Posted:

Mar 17, 2022

Last Update Posted:

Mar 17, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Atrophy

Study Results

No Results Posted as of Mar 17, 2022