Bone Height Changes In Three Implants Retained Mandibular Overdenture

NCT ID: NCT04928274

Last Updated: 2021-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2021-04-15

Brief Summary

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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

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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.

Conditions

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Bone Loss Implant Site Reaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

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

Study Groups

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ball retained mandibular over denture

each patient in this group received 3 implant installed in mandible and 3 ball attachments for retention of over denture

Group Type OTHER

ball attachment to retain mandibular over denture

Intervention Type OTHER

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

locator retained mandibular over denture

Group Type OTHER

locator attachment to retain mandibular over denture

Intervention Type OTHER

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

telescopic retained mandibular over denture

Group Type OTHER

telescopic attachment to retain mandibular over denture

Intervention Type OTHER

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

Interventions

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ball attachment to retain mandibular over denture

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

Intervention Type OTHER

locator attachment to retain mandibular over denture

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

Intervention Type OTHER

telescopic attachment to retain mandibular over denture

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role collaborator

Kafrelsheikh University

OTHER

Sponsor Role lead

Responsible Party

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Nourhan Ahmed Ragheb

Lecturer , Prosthodontist, Department of Prosthodontics, Faculty of Oral & Dental Medicine,Kafr El-shiekh University, Kafr El-shiekh ,Egypt.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nouran Abdel Nabi, phd

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Faculty of Dentistry , Kafrelshiekh university

Kafr ash Shaykh, Kafr el-Sheikh Governorate, Egypt

Site Status

Cairo University

Cairo, , Egypt

Site Status

Faculty of Dentistry , Kafr El Shiekh University

Kafr ash Shaykh, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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KD/11/21

Identifier Type: -

Identifier Source: org_study_id

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