Treatment Outcomes With Full Arch Rehabilitations Retained by Immediate or Conventionally Loaded Implants

Study Overview
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Brief Summary
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This study aims to assess the treatment outcomes (clinical, functional and subjective) of full arch rehabilitations supported by implants with or without an immediate loading protocol. In this randomized clinical trial 20 fully edentulous patients were treated with full arch rehabilitations on dental implants. In half of the sample, the implants were loaded immediately by means of abutments after emplacement of the implant; but in the counterparts these abutments were connected to implants two months after the surgery (conventional protocol), and until that time the dentures were retained by healing abutments. Treatment outcomes were assessed at 2, 6 and 12 months after surgery. Clinical outcomes were quantified on the basis of implant failure rate, marginal bone loss and the peri-implant gingival index. Functional outcomes were calculated according to masticatory performance, estimated by the mixed fraction of a two-coloured chewing gum after 5, 10 and 15 chewing strokes, by the occlusal force recorded by pressure-sensitive sheets and by the bioelectrical muscular activity. The subjective outcomes of the treatment were assessed using both the oral satisfaction scale (visual analogue scale) and the Spanish version of the Oral Health Impact Profile (OHIP-20).

Official Title
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Treatment Outcomes With Full Arch Rehabilitations Supported by Immediate or Conventionally Loaded Implants: A Randomized Clinical Trial

Conditions
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Edentulous Jaw, Missing Teeth

Intervention / Treatment
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* Procedure: Implant supported dentures


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: completely edentulous individuals who had lacked teeth for more than 10 years, routine users of conventional complete prostheses. sufficient amount of remaining bone to receive the implants in the region of the mandibular canines (minimum height=15 mm/minimum ridge width= 5mm) no evidence of systemic or psychic pathology that might contraindicate the implant treatment. Exclusion Criteria: Those in which oral surgery or cognitive evaluations are contraindicated

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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No

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 |
| --- | --- |
| Active Comparator: Conventional Loading<br>implants are loaded at least after two months of healing | Procedure: Implant supported dentures<br>* Placement of dental implants with different loading protocols for supporting full arch dentures.<br>|
| Experimental: Immediate Loading<br>implants are loaded the same day of surgery | Procedure: Implant supported dentures<br>* Placement of dental implants with different loading protocols for supporting full arch dentures.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Performance of Dental implants | Implant failure rate | One year after treatment | 
| Oral health-related quality of life | impact according to the OHIP-20 (Oral Health Impact Profile) instrument. The score range from 0 to 20, being 20 the worst outcome. | One year after treatment | 
| Mastication | Mixing ability tests | One year after treatment | 
| Area of Occlusal Occlusion | According to pressure-sensitive colorimetric sheets it is recorded the area in square millimeters | One year after treatment | 
| Occlusal Load | According to the pressure-sensitive colorimetric sheets , the load in both the anterior and posterior region of the arch are calculated. | One year after treatment |