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

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

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).

Study Overview

• Status: Completed
• Conditions: Missing Teeth; Edentulous Jaw
• Intervention / Treatment: Procedure: Implant supported dentures

• Study Type: Interventional
• Enrollment (Actual): 20
• 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:

• 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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional Loading; implants are loaded at least after two months of healing	Procedure: Implant supported dentures; Placement of dental implants with different loading protocols for supporting full arch dentures.
Experimental: Immediate Loading; implants are loaded the same day of surgery	Procedure: Implant supported dentures; Placement of dental implants with different loading protocols for supporting full arch dentures.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Salamanca

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2018
• Primary Completion (Actual): January 11, 2018
• Study Completion (Actual): January 11, 2021

Study Registration Dates

• First Submitted: June 10, 2021
• First Submitted That Met QC Criteria: June 17, 2021
• First Posted (Actual): June 18, 2021

Study Record Updates

• Last Update Posted (Actual): June 18, 2021
• Last Update Submitted That Met QC Criteria: June 17, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Jaw Diseases; Tooth Abnormalities; Mouth, Edentulous; Tooth Loss; Jaw, Edentulous; Anodontia
• Other Study ID Numbers: ILOD

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