An interventional study of Bar-Clip attachment and Bar- OT Equator attachment in Edentulous Alveolar Ridge, Complete Edentulism and Dental Implant, sponsored by Al-Azhar University. Active, not recruiting at 1 site in Egypt. Open to participants aged 60 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-16.
Sponsored by Al-Azhar University · Not applicable, Interventional, and Treatment
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)
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.
246 studies on the registry are indexed under Mouth, Edentulous; 38 are open to participants now.
This study's enrollment of 20 is below the median of 30 across 189 interventional studies indexed under Mouth, Edentulous.
Browse Mouth, Edentulous studies →Al-Azhar University is the lead sponsor of 525 studies on the registry; 171 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
on the 2nd stage, implants will be loaded with bar-clip attachments to support overdenture
Procedure: Bar-Clip attachment
on the 2nd stage, implants will be loaded with Bar- OT Equator attachments to support overdenture
Procedure: Bar- OT Equator attachment
The 2 implants will be connected with bar attachments while the denture will be retained over the bar using clip.
The 2 implants will be connected with bar attachments while the denture will be retained over the bar using the OT Equator.
Retention
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.
Time frame: it will be measured at denture insertion, 3 month, and 6 month later
Patient satisfaction
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
Time frame: it will be measured at denture insertion, 3 month, and 6 month later.
Plan to share: Yes — Study Protocol and Clinical Study Report
Supporting information: Study protocol, Clinical study report
Time frame: Start Date: After publication End Date: 10 years
Access criteria: After publication through the corresponding author
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.