Evaluation of Different Attachments on Implant-Retained Mandibular Overdenture.

NCT06721377 | Recruiting DMC

• 1 other identifier: REC al azhar university
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Edentulism in Lower Jaw; Edentulism

Keywords

overdenture; implant placemnent; Novaloc attachment.; Equator attachment; edentulism

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Pocket depth

  at baseline, 6 and 12 months

Study Arms (2)

control

ACTIVE COMPARATOR

Equator attachment

Procedure: Novaloc attachment

study

EXPERIMENTAL

Novaloc attachment

Procedure: Equator attachment

Interventions

Novaloc attachment PROCEDURE

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.

control

Equator attachment PROCEDURE

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.

study

Eligibility Criteria

• Age: 65 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Faculty of Dental Medicine , Al Azhar Univeristy For Girls

Cairo, Nasr City - Cairo, 123456, Egypt

RECRUITING

Study Officials

• sara H kadry, masters

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara H Kadry, masters

CONTACT

02-01226595217; Sarra.kadry@miuegypt.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: November 30, 2024
• First Posted: December 6, 2024
• Study Start: September 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)