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

Study Overview
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Brief Summary
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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.

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

Conditions
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Edentulous; Alveolar Process, Atrophy

Intervention / Treatment
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* Device: dental implant with transepithelial abutments manufactured by Galimplant Dental System (Spain)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Mechanized parallel abutments<br>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)<br>* Dental implants with transepithelial abutments with distinct morphology<br>|
| Experimental: Anodized parallel abutments<br>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)<br>* Dental implants with transepithelial abutments with distinct morphology<br>|
| Experimental: Mechanized convergent abutments<br>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)<br>* Dental implants with transepithelial abutments with distinct morphology<br>|
| Experimental: Anodized convergent abutments<br>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)<br>* Dental implants with transepithelial abutments with distinct morphology<br>|

What is the study measuring?
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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 |