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

Not Applicable

Completed

• Conditions: Missing Teeth; Edentulous Jaw
• Interventions: Procedure: Implant supported dentures

• Registration Number: NCT04930835
• Lead Sponsor: University of Salamanca

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-11
• Primary Completion: 2018-01-11
• Study Completion: 2021-01-11
• Status Verified: 2021-06
• Study First Submitted: 2021-06-10
• Study First Submitted QC: 2021-06-17
• Last Update Submitted: 2021-06-17
• Study First Posted: 2021-06-18
• Last Update Posted: 2021-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Loading	Implant supported dentures	implants are loaded at least after two months of healing
Immediate Loading	Implant supported dentures	implants are loaded the same day of surgery

Primary Outcome Measures

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

Trial Locations

Locations (1)

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