Bone Height Changes In Three Implants Retained Mandibular Overdenture

Not Applicable

Completed

• Conditions: Bone Loss; Implant Site Reaction
• Interventions: Other: telescopic attachment to retain mandibular over denture; Other: locator attachment to retain mandibular over denture; Other: ball attachment to retain mandibular over denture

• Registration Number: NCT04928274
• Lead Sponsor: Kafrelsheikh University

Brief Summary

this study was to compare the bone height changes around three implant telescopic, locator, and ball retained mandibular overdentures. radiographic changes in peri-implant tissue in three groups were evaluated

Detailed Description

Twenty-four completely edentulous patients were recruited from the outpatient clinic of Removable Prosthodontics Cairo University. All patients recruited were seeking to install implants in their lower jaw, and have to meet the following inclusion criteria: age ranging from 50 to 69 years old, patients should have no contra-indication for implant installation, all patients should perform a glycosylated hemoglobin analysis and only up to 8 were included in the study. All patients had to sign an informed consent before the start of the study, and have to comply with the assigned follow-ups. Patients with any contraindications for implant placement or those who didn't comply with the follow ups were excluded from the study.

All patients included had maxillary and mandibular complete dentures fabricated following the conventional steps, after a period of 6 weeks adaptation, all patients were ready for implant installation. The lower denture was duplicated into a radiographic stent, having radio-opaque markers in the areas of implant installation. All patients had a CBCT x ray wearing the radiographic stent, to allow for proper implant planning and to visualize the height and width of the osteotomy site. The radiographic stent was then modified to a surgical stent by making a tunnel corresponding to the site of implant installation. All Patients in this study received three implants in the lower jaw at the premolar-canine area bilaterally and one implant in the midline at the central incisor area.

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2021-03-15
• Study Completion: 2021-04-15
• Study First Submitted: 2021-06-04
• Study First Submitted QC: 2021-06-09
• Study First Posted: 2021-06-16
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-31
• Last Update Posted: 2021-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• age ranging from 50 to 69 years old, patients should have no contra-indication for implant installation, all patients should perform a glycosylated hemoglobin analysis and only up to 8 were included in the study

Read More

Exclusion Criteria

• Patients with any contraindications for implant placement or those who didn't comply with the follow ups were excluded from the study.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
telescopic retained mandibular over denture	telescopic attachment to retain mandibular over denture	-
locator retained mandibular over denture	locator attachment to retain mandibular over denture	-
ball retained mandibular over denture	ball attachment to retain mandibular over denture	each patient in this group received 3 implant installed in mandible and 3 ball attachments for retention of over denture

Primary Outcome Measures

Name	Time	Method
Bone height measurement	one year	The Digora software was then used to measure bone height changes on the mesial and distal surface of each implant. The Digora software was then used to measure bone height changes on the mesial and distal surface of each implant. The implant in the peri-apical x ray was calibrated by drawing a line from the junction of the implant and abutment to the apical end of the implant, this line was the calibration line corresponding to the implant real length which was 11.5mm. After the implant was calibrated, a line was drawn on each implant surface; at the mesial and distal surface starting from the first implant thread to bone contact to the apical implant thread to bone contact. The line drawn would correspond to the bone height on each surface . Two blinded operators have carried out the assessment of bone height changes in order to have accurate results.

Trial Locations

Locations (3)

Faculty of Dentistry , Kafr El Shiekh University; 🇪🇬 Kafr Ash Shaykh, Egypt

Cairo University; 🇪🇬 Cairo, Egypt

Faculty of Dentistry , Kafrelshiekh university; 🇪🇬 Kafr El Sheikh, Egypt