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

Edentulous; Alveolar Process, Atrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05284461
• Other study ID #: USAL_2021_JMONT
• Status: Completed
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: September 1, 2021

Study information

• Verified date: February 2022
• Source: University of Salamanca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrophy
• Edentulous; Alveolar Process, Atrophy

Intervention

Device:
• dental implant with transepithelial abutments manufactured by Galimplant Dental System (Spain)
Dental implants with transepithelial abutments with distinct morphology

Locations

Country	Name	City	State
Spain	Clinica Odontológica de la Universidad de Salamanca	Salamanca

Sponsors (1)

Lead Sponsor	Collaborator
University of Salamanca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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