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

Not Applicable

Completed

• Conditions: Edentulous; Alveolar Process, Atrophy
• Interventions: Device: dental implant with transepithelial abutments manufactured by Galimplant Dental System (Spain)

• Registration Number: NCT05284461
• Lead Sponsor: University of Salamanca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-01
• Primary Completion: 2021-01-01
• Study Completion: 2021-09-01
• Status Verified: 2022-02
• Study First Submitted: 2022-02-02
• Study First Submitted QC: 2022-03-08
• Last Update Submitted: 2022-03-08
• Study First Posted: 2022-03-17
• Last Update Posted: 2022-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mechanized parallel abutments	dental implant with transepithelial abutments manufactured by Galimplant Dental System (Spain)	Implants were immediately covered with this type of abutments after insertion. This is the most common procedure. It would be the gold standard
Mechanized convergent abutments	dental implant with transepithelial abutments manufactured by Galimplant Dental System (Spain)	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
Anodized parallel abutments	dental implant with transepithelial abutments manufactured by Galimplant Dental System (Spain)	Implants were immediately covered with this kind of abutments after insertion. Only the surface treatment varies to the gold standard
Anodized convergent abutments	dental implant with transepithelial abutments manufactured by Galimplant Dental System (Spain)	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

Primary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Clinica Odontológica de la Universidad de Salamanca; 🇪🇸 Salamanca, Spain