Actively Recruiting

Phase Not Applicable
Age: 65Years - 69Years
All Genders
Healthy Volunteers
ID06721377

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

Led by Al-Azhar University · Updated on 2024-12-06

10

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying patients with edentulism, or missing teeth, focusing on the lower jaw. The study aims to evaluate and compare two different dental implant attachments, Novaloc and Equator, used to support mandibular overdentures. The trial is conducted with patients aged 65 to 69 years, recruited from a dental outpatient clinic, and involves informed consent after explaining treatment options and expected outcomes. All participants will receive upper complete dentures that rest on the gums and lower complete overdentures supported and retained by two dental implants placed in the front lower jaw area. Patients are randomly divided into two groups: one group will have their implants loaded with Novaloc attachments, and the other with Equator attachments. Implant loading will occur three months after implant insertion. Participants will undergo clinical and radiographic evaluations at the start of the study, then again at 6 and 12 months to measure bone height and density around the implants. Pocket depth around the implants will also be measured at these times. Throughout the study, dental health and implant function will be closely monitored to assess the impact of the different attachments over one year.

CONDITIONS

Brief Title

Evaluation of Different Attachments on Implant-Retained Mandibular Overdenture.

Who Can Participate

Age: 65Years - 69Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients must have firm mucosa on the jaw ridges without inflammation or ulcers
  • Patients should have no bone disorders and adequate height and width of the residual alveolar ridge
  • Patients must have sufficient space between the upper and lower jaws
  • Patients aged between 65 and 69 years
  • Patients must be able to give informed consent
Not Eligible

You will not qualify if you...

  • Patients with oral or systemic diseases
  • Patients experiencing dry mouth or excessive salivation
  • Patients with habits like teeth grinding or jaw clenching (parafunctional habits)
  • Heavy smokers or alcoholic patients
  • Patients with a history of temporo-mandibular joint dysfunction
  • Patients with brain or psychiatric disorders

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Day of surgery and initial recovery period

Participants receive two dental implants in the inter-foraminal region and upper complete dentures with lower complete overdentures.

1 surgery visit and follow-up visits as needed

Run-in Period

Duration - 3 months

Participants wait for three months after implant insertion before functional loading.

Visits as needed for recovery monitoring

Treatment

Duration - Up to 12 months

Participants are randomly assigned to receive either Novaloc or Equator attachments on their implant-retained mandibular overdentures, which are functionally loaded.

Visits at baseline, 6 months, and 12 months for radiographic and clinical evaluations

Trial Site Locations

Total: 1 location

1

Faculty of Dental Medicine , Al Azhar Univeristy For Girls

Cairo, Nasr City - Cairo, Egypt, 123456

Actively Recruiting

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Research Team

S

Sara H Kadry, masters

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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