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Bone Height Changes In Three Implants Retained Mandibular Overdenture

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04928274
Enrollment
24
Registered
2021-06-16
Start date
2020-01-01
Completion date
2021-04-15
Last updated
2021-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Loss, Implant Site Reaction

Keywords

implant - over denture - bone height changes - attachment

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.

Interventions

OTHERball attachment to retain mandibular over denture

each patient in group receive 3 locator attachment for over denture retention

OTHERlocator attachment to retain mandibular over denture

each patient in group receive 3 locator attachment for over denture retention

OTHERtelescopic attachment to retain mandibular over denture

each patient in group receive 3 telescopic attachment for over denture retention

Sponsors

Cairo University
CollaboratorOTHER
Kafrelsheikh University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Two blinded operators have carried out the assessment of bone height changes in order to have accurate results.

Eligibility

Sex/Gender
ALL
Age
50 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Bone height measurementone yearThe 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026