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NCT Number: NCT06678945

Using Two Different Attachments in Mandibular Implant Overdenture Cases in Order to Retention and Patient Satisfaction

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)

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Edentulous Alveolar Ridge Attachments Complete Edentulism Dental Implant Edentulous Jaw Edentulous Mouth Implant Supported Overdenture Jaw Diseases Jaw, Edentulous Mouth Diseases Mouth, Edentulous Musculoskeletal Diseases Stomatognathic Diseases Tooth Diseases

Age range

60 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Giza, Al Saraya, Old Cairo, 11553, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Bar-Clip attachment

Procedure

The 2 implants will be connected with bar attachments while the denture will be retained over the bar using clip.

Bar- OT Equator attachment

Procedure

The 2 implants will be connected with bar attachments while the denture will be retained over the bar using the OT Equator.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

Comparing Two Different Attachments Retaining Mandibular Implant Overdenture Regarding Retention and Patient Satisfaction (Randomized Clinical Trail)

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Nov 7, 2024
Registry last updated
Dec 16, 2024

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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