Comparison of Short Implant Assisted Mandibular Overdenture Designs (A Randomized Clinical Trial)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Crestal bone loss
Study Overview
Brief Summary
The aim of the study was to clinically and radiographically evaluate and compare the use of unsplinted and splinted short implants with ball abutments to support mandibular overdentures in cases with severe mandibular ridge resorption.
Detailed Description
Twelve patients from the Prosthodontics Department in the Faculty of Dentistry, Alexandria University participated in the study. Patients were divided into 2 groups. The test group received 4 short implants with ball abutments for the construction of a mandibular assisted overdenture, while the control group received 4 short implants splinted using a bar with a ball attachment for retaining a mandibular overdenture.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Completely edentulous patients.
- •Mandibular ridge should be a maximum of 10mm height and with a minimum width of 8 mm to insert implants without grafting procedures.
- •Patients free from systemic diseases that contradict the use of dental implants.
- •Patients with class I ridge relation.
- •Patients with adequate zone of keratinized mucosa.
- •Patients with U-shaped or square shaped arches
Exclusion Criteria
- •Non-compliant patients based on history.
- •Heavy smokers.
- •Senile patients (over 75 years) with impaired neuromuscular control.
Arms & Interventions
Unsplinted implants
Intervention: Unsplinted implants (Other)
Splinted implants
Intervention: Splinted implants (Other)
Outcomes
Primary Outcomes
Crestal bone loss
Time Frame: up to 12 months
Mesial and Distal crestal bone loss were evaluated using digital periapical x-rays. In order to standardize the cones' and sensors' position and angulation, a film positioning system was used along with a customized silicone bite.
Implant stability
Time Frame: up to 12 months
Stability was assessed using resonance frequency analysis measured with the Osstell device instrument. The Osstell unit records a numeric value of 1-100 which is referred to as the implant stability quotient (ISQ). The measurements were performed and 3 mean of three readings were recorded in each evaluation period.
Peri-implant probing depth
Time Frame: up to 12 months
Peri-implant probing depth refers to the distance between the gingival margin and the most apically probable portion in millimeters (mm). The peri-implant probing depth was measured using a graduated plastic periodontal probe. The probe was held parallel to the long axis of the implant and introduced to the peri-implant sulcus until slight resistance was felt. Measurements were made at four sites around each implant; buccal, lingual, mesial and distal. Probing depth of 1 mm or less was recorded as "1mm", and those exceeding 1 mm but less than 2 mm were recorded as "2mm" and so forth. The mean records for each implant were then calculated.
Clinical attachment loss
Time Frame: up to 12 months
It is the distance from the junction implant/abutment to the most apically probable portion, in millimeters. Assessment of the clinical attachment level was performed simultaneously while measuring the peri-implant probing depth.
Gingival inflammation (Modified gingival index)
Time Frame: up to 12 months
The peri-implant mucosal tissues around the implants were assessed using Apse's modification of Löe and Silness index. The criteria for assessment were: 0 =Normal mucosa, 1 =Mild inflammation, slight change in colour and texture, slight oedema and no bleeding on probing, 2 =Mild inflammation, redness, in all portions of gingival margin, 3 =Moderate inflammation, 4 =Severe inflammation. The gingival index was assessed at 4 sites around each implant (buccal, lingual, mesial and distal) the sum gingival index score was calculated from all these surfaces and then divided by 4 to obtain the gingival index for each implant. Indices of the three implants were added to each other, and then divided by 3 to get the mean gingival index for each case. A score from 0.1-1.0 reflects mild inflammation; 1.1-2.0 reflects moderate inflammation from, and 2.1-3.0 signifies severe inflammation.
Secondary Outcomes
No secondary outcomes reported
Investigators
Nourhan M.Aly
Assistant Lecturer of Dental Public Health
University of Alexandria