Clinical trial NCT04928274: Bone Height Changes In Three Implants Retained Mandibular Overdenture
Official title: Evaluation of Bone Height Changes In Three Implants Retained Mandibular Overdenture Using Three Different Attachment Design. A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Loss
Implant Site Reaction
Keywords: implant - over denture - bone height changes - attachment
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2021-06-16
Enrollment: 24
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Bone height measurement
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
city: Kafr Ash Shaykh
country: Egypt
facility: Faculty of Dentistry , Kafr El Shiekh University
city: Kafr El Sheikh
country: Egypt
facility: Faculty of Dentistry , Kafrelshiekh university
Study officials:
affiliation: Cairo University
name: Nouran Abdel Nabi, phd
role: PRINCIPAL_INVESTIGATOR
References: