Using Two Different Attachments in Mandibular Implant Overdenture Cases in Order to Retention and Patient Satisfaction
Comparing Two Different Attachments Retaining Mandibular Implant Overdenture Regarding Retention and Patient Satisfaction (Randomized Clinical Trail)
The Goal of the clinical trail is to evaluate the efficacy of Bar- OT Equator attachment on retention and patient satisfaction in comparison to the standard technique using Bar- clip attachment.
Patients will visit the clinic after the surgery and after the attachment insertion for check ups and during the follow up periods ( at denture insertion, 3 months and 6 months)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
patients will receive upper complete dentures and lower complete overdentures. The upper complete denture will be mucosa supported and the lower complete denture will be supported and retained for all patients by two dental implants in the inter-foraminal region. Patients will be divided into two equal groups; Group I will be retained by Bar-Clip attachment, while Group II will be retained by Bar- OT Equator attachment. Both groups will be functionally loaded after three months of insertion.
Retention of lower denture will be measured using digital force gauge and Patient satisfaction was evaluated with a standard 5-point Liker scale questionnaire. All parameters will be measured at denture insertion, 3 month, and 6 month later.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Al Saraya, Old Cairo
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Giza, Al Saraya, Old Cairo, Egypt, 11553
- Cairo University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- All patients age must range from 60- 70 years old.
- All patients' ridges should be covered with firm mucosa free from any signs of inflammation or ulceration and exhibit adequate height and width of the residual alveolar ridge.
- Patients should be free from any metabolic or bone disorder that contraindicate implant installation.
- All patients must have sufficient inter arch space
Exclusion Criteria:
- Patients with oral or systemic diseases.
- Patients with xerostomia or excessive salivation.
- Patients with parafunctional habits (bruxism or clenching).
- Heavy smoker or alcoholic patients.
- Patients with history of temporo-mandibular dysfunction.
- Patients with brain disorders or psychiatric disorders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Bar-Clip attachment
on the 2nd stage, implants will be loaded with bar-clip attachments to support overdenture
|
The 2 implants will be connected with bar attachments while the denture will be retained over the bar using clip.
|
|
Experimental: Bar- OT Equator attachment
on the 2nd stage, implants will be loaded with Bar- OT Equator attachments to support overdenture
|
The 2 implants will be connected with bar attachments while the denture will be retained over the bar using the OT Equator.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Retention
Time Frame: it will be measured at denture insertion, 3 month, and 6 month later
|
Retention will be measured using digital force gauge A digital force meter was used to measure denture resistance to vertical displacement (i.e., retention) by applying a pulling force on a metal hook located in the geometric center of each mandibular conventional denture that was identified on the lower cast at the intersection of three lines bisecting the angles of the triangle, formed by both retromolar pads and the midline. Measurement of mandibular denture retention: The patient was instructed to place his head on chin rest and occlusal plane was set parallel to the floor. Tongue freedom was checked then and three minutes seating time was allowed before taking the measurements. A vertical pulling force was applied using the metallic probe of the digital force-meter that was attached to the hook present at the geometric center of mandibular denture. Average value of six readings was recorded. |
it will be measured at denture insertion, 3 month, and 6 month later
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient satisfaction
Time Frame: it will be measured at denture insertion, 3 month, and 6 month later.
|
Patient satisfaction was evaluated with a standard 5-point Liker scale questionnaire, which included subjective parameters such as initial adaptability, post insertion problems, aesthetics, masticatory ability, speech, retention.
Patients were asked to respond to questions given in the questionnaire
|
it will be measured at denture insertion, 3 month, and 6 month later.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 27 4 24
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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