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

NCT04930835 | Completed DMC

• 1 other identifier: ILOD
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Conventional Loading

ACTIVE COMPARATOR

implants are loaded at least after two months of healing

Procedure: Implant supported dentures

Immediate Loading

EXPERIMENTAL

implants are loaded the same day of surgery

Procedure: Implant supported dentures

Interventions

Implant supported dentures PROCEDURE

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

Conventional Loading; Immediate Loading

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Those in which oral surgery or cognitive evaluations are contraindicated

Sponsors & Collaborators

• University of Salamanca: lead

Study Sites (1)

Clinica Odontológica de la Universidad de Salamanca

Salamanca, 37007, Spain

Location

MeSH Terms

Conditions

Jaw, Edentulous; Anodontia

Interventions

Dental Prosthesis, Implant-Supported

Condition Hierarchy (Ancestors)

Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth Diseases; Tooth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor in Prosthodontics at the University of Salamanca

Study Record Dates

• First Submitted: June 10, 2021
• First Posted: June 18, 2021
• Study Start: January 11, 2018
• Primary Completion: January 11, 2018
• Study Completion: January 11, 2021
• Last Updated: June 18, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)