Back to resultsTreatment Outcomes With Full Arch Rehabilitations Retained by Immediate or Conventionally Loaded Implants (ILOD)
Primary Purpose
Edentulous Jaw, Missing Teeth
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Implant supported dentures
Sponsored by
About this trial
This is an interventional treatment trial for Edentulous Jaw
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
Sites / Locations
- Clinica Odontológica de la Universidad de Salamanca
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional Loading
Immediate Loading
Arm Description
implants are loaded at least after two months of healing
implants are loaded the same day of surgery
Outcomes
Primary Outcome Measures
Clinical Performance of Dental implants
Implant failure rate
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.
Mastication
Mixing ability tests
Area of Occlusal Occlusion
According to pressure-sensitive colorimetric sheets it is recorded the area in square millimeters
Occlusal Load
According to the pressure-sensitive colorimetric sheets , the load in both the anterior and posterior region of the arch are calculated.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04930835
Brief Title
Treatment Outcomes With Full Arch Rehabilitations Retained by Immediate or Conventionally Loaded Implants
Acronym
ILOD
Official Title
Treatment Outcomes With Full Arch Rehabilitations Supported by Immediate or Conventionally Loaded Implants: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
January 11, 2018 (Actual)
Primary Completion Date
January 11, 2018 (Actual)
Study Completion Date
January 11, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Salamanca
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edentulous Jaw, Missing Teeth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional Loading
Arm Type
Active Comparator
Arm Description
implants are loaded at least after two months of healing
Arm Title
Immediate Loading
Arm Type
Experimental
Arm Description
implants are loaded the same day of surgery
Intervention Type
Procedure
Intervention Name(s)
Implant supported dentures
Intervention Description
Placement of dental implants with different loading protocols for supporting full arch dentures.
Primary Outcome Measure Information:
Title
Clinical Performance of Dental implants
Description
Implant failure rate
Time Frame
One year after treatment
Title
Oral health-related quality of life
Description
impact according to the OHIP-20 (Oral Health Impact Profile) instrument. The score range from 0 to 20, being 20 the worst outcome.
Time Frame
One year after treatment
Title
Mastication
Description
Mixing ability tests
Time Frame
One year after treatment
Title
Area of Occlusal Occlusion
Description
According to pressure-sensitive colorimetric sheets it is recorded the area in square millimeters
Time Frame
One year after treatment
Title
Occlusal Load
Description
According to the pressure-sensitive colorimetric sheets , the load in both the anterior and posterior region of the arch are calculated.
Time Frame
One year after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Clinica Odontológica de la Universidad de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Treatment Outcomes With Full Arch Rehabilitations Retained by Immediate or Conventionally Loaded Implants
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