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

NCT ID: NCT04930835

Last Updated: 2021-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-11
• Study Completion Date: 2021-01-11

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).

Conditions

Edentulous Jaw; Missing Teeth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Conventional Loading

implants are loaded at least after two months of healing

Group Type: ACTIVE_COMPARATOR

Implant supported dentures

Intervention Type: PROCEDURE

Placement of dental implants with different loading protocols for supporting full arch dentures.

Immediate Loading

implants are loaded the same day of surgery

Group Type: EXPERIMENTAL

Implant supported dentures

Intervention Type: PROCEDURE

Placement of dental implants with different loading protocols for supporting full arch dentures.

Interventions

Implant supported dentures

Placement of dental implants with different loading protocols for supporting full arch dentures.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Salamanca

OTHER

Sponsor Role: lead

Responsible Party

JAVIER MONTERO

Full professor in Prosthodontics at the University of Salamanca

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Clinica Odontológica de la Universidad de Salamanca

Salamanca, , Spain

Countries

Spain

Other Identifiers

ILOD

Identifier Type: -

Identifier Source: org_study_id