Bone Height Changes In Three Implants Retained Mandibular Overdenture

Bone Loss Clinical Trial

Official title:

Evaluation of Bone Height Changes In Three Implants Retained Mandibular Overdenture Using Three Different Attachment Design. A Randomized Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04928274
• Other study ID #: KD/11/21
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: April 15, 2021

Study information

• Verified date: August 2021
• Source: Kafrelsheikh University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 15, 2021
• Est. primary completion date: March 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 65 Years

Eligibility

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Bone Loss
• Implant Site Reaction

Intervention

Other:
• ball attachment to retain mandibular over denture
each patient in group receive 3 locator attachment for over denture retention
• locator attachment to retain mandibular over denture
each patient in group receive 3 locator attachment for over denture retention
• telescopic attachment to retain mandibular over denture
each patient in group receive 3 telescopic attachment for over denture retention

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo
Egypt	Faculty of Dentistry , Kafr El Shiekh University	Kafr Ash Shaykh
Egypt	Faculty of Dentistry , Kafrelshiekh university	Kafr El Sheikh

Sponsors (2)

Lead Sponsor	Collaborator
Kafrelsheikh University	Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone height measurement	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.	one year