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

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

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.

Study Overview

• Status: Completed
• Conditions: Edentulous; Alveolar Process, Atrophy
• Intervention / Treatment: Device: dental implant with transepithelial abutments manufactured by Galimplant Dental System (Spain)

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Salamanca, Spain, 37007
    • Clinica Odontológica de la Universidad de Salamanca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Salamanca

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Actual): January 1, 2021
• Study Completion (Actual): September 1, 2021

Study Registration Dates

• First Submitted: February 2, 2022
• First Submitted That Met QC Criteria: March 8, 2022
• First Posted (Actual): March 17, 2022

Study Record Updates

• Last Update Posted (Actual): March 17, 2022
• Last Update Submitted That Met QC Criteria: March 8, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: USAL_2021_JMONT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No