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

Edentulous Jaw Clinical Trial

— ILOD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04930835
• Other study ID #: ILOD
• Status: Completed
• Phase: N/A
• Start date: January 11, 2018
• Est. completion date: January 11, 2021

Study information

• Verified date: June 2021
• Source: University of Salamanca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 11, 2021
• Est. primary completion date: January 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anodontia
• Edentulous Jaw
• Jaw, Edentulous
• Missing Teeth
• Tooth Loss

Intervention

Procedure:
• Implant supported dentures
Placement of dental implants with different loading protocols for supporting full arch dentures.

Locations

Country	Name	City	State
Spain	Clinica Odontológica de la Universidad de Salamanca	Salamanca

Sponsors (1)

Lead Sponsor	Collaborator
University of Salamanca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Performance of Dental implants	Implant failure rate	One year after treatment
Primary	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
Primary	Mastication	Mixing ability tests	One year after treatment
Primary	Area of Occlusal Occlusion	According to pressure-sensitive colorimetric sheets it is recorded the area in square millimeters	One year after treatment
Primary	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