Evaluation of Different Attachments on Implant-Retained Mandibular Overdenture. (Overdenture)

Clinical and Radiographic Evaluation of Different Attachments on Implant-Retained Mandibular Overdenture.

Patients will be selected from the outpatient clinic of Removable Prosthodontic Department. Faculty of Dental Medicine for Girls, Al-Azhar University..

Each patient will be assessed for eligibility and Informed consent will be obtained from patient after explanation of the treatment protocols and expected outcomes or alternative management.

Study Overview

• Status: Recruiting
• Conditions: Edentulism; Edentulism in Lower Jaw
• Intervention / Treatment: Procedure: Novaloc attachment; Procedure: Equator attachment

Detailed Description

All 10 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 groups, one group will be loaded by Novaloc attachment. While the other group will be loaded by Equator attachment. Implants will be functionally loaded after three months of insertion.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sara H Kadry, Masters; Phone Number: 02-01226595217; Email: sarra.kadry@miuegypt.edu.eg

Study Locations

• Egypt
  • Nasr city - Cairo
    • Cairo, Nasr city - Cairo, Egypt, 123456
      • Recruiting
      • Faculty of Dental Medicine , Al Azhar Univeristy For Girls
      • Contact: Sara H Kadry, Masters; Phone Number: 02-01226595217; Email: sarra.kadry@miuegypt.edu.eg
      • Contact: zainab H Abdel rahman, Phd; Phone Number: 02-01221334637; Email: zainab_hafez_87@hotmail.com
      • Contact: Sara H Kadry, Masters

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• All patients' ridges should be covered with firm mucosa which is free from any signs of inflammation or ulceration.
• Patients should be free from any bone disorder and exhibit adequate height and width of the residual alveolar ridge.
• 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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control; Equator attachment	Procedure: Novaloc attachment; 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 & will be loaded by Novaloc attachment.
Experimental: study; Novaloc attachment	Procedure: Equator attachment; 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& will be loaded by Equator attachment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic evaluation of bone height	Radiographic evaluation of bone height around each implant and at distal extension area will be evaluated using cone beam CT (CBCT)	at baseline, 6 and 12 months
Radiographic evaluation of bone density	Radiographic evaluation of bone density around implant and at distal extension area will be evaluated using cone beam CT (CBCT)	at baseline, 6 and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pocket depth	Pocket depth will be measured using periodontal probe	at baseline, 6 and 12 months

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Investigators: Principal Investigator: sara H kadry, masters

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Actual): December 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: November 30, 2024
• First Submitted That Met QC Criteria: December 5, 2024
• First Posted (Estimated): December 6, 2024

Study Record Updates

• Last Update Posted (Estimated): December 6, 2024
• Last Update Submitted That Met QC Criteria: December 5, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: edentulism; overdenture; implant placemnent; Novaloc attachment.; Equator attachment
• Other Study ID Numbers: REC al azhar university

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No