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Completed

NCT Number: NCT04928274

Bone Height Changes In Three Implants Retained Mandibular Overdenture

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

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Key information

Conditions

Bone Loss Bone Diseases Bone Diseases, Metabolic Implant Site Reaction Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

50 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry , Kafrelshiekh university, Kafr ash Shaykh, Kafr el-Sheikh Governorate, Egypt

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ball attachment to retain mandibular over denture

Other

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

locator attachment to retain mandibular over denture

Other

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

telescopic attachment to retain mandibular over denture

Other

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

Primary outcomes

  1. Bone height measurement

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Collaborators

  • Cairo University

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 16, 2021
Registry last updated
Sep 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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