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RecruitingNCT06721377OverdentureUpdated Dec 6, 2024

Evaluation of Different Attachments on Implant-Retained Mandibular Overdenture.

An interventional study of Novaloc attachment and Equator attachment in Edentulism in Lower Jaw and Edentulism, sponsored by Al-Azhar University. Recruiting at 1 site in Egypt. Open to participants aged 65 Years to 69 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-06.

Sponsored by Al-Azhar University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Sep 2023, registered Nov 2024).
  • Started Sep 2023; still recruiting 3 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
65 Years to 69 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Edentulism in Lower Jaw
  • Edentulism

Keywords

  • overdenture
  • implant placemnent
  • Novaloc attachment.
  • Equator attachment
  • edentulism
03

In context

Lead sponsor

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.

04

Who can participate

Ages eligible
65 Years to 69 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
10 participants (estimated)

Study arms

  • Active comparator
    control

    Equator attachment

    Procedure: Novaloc attachment

  • Experimental
    study

    Novaloc attachment

    Procedure: Equator attachment

Interventions

  • ProcedureNovaloc 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.

  • ProcedureEquator 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.

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: at baseline, 6 and 12 months

  2. 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)

    Time frame: at baseline, 6 and 12 months

Secondary outcomes

  1. Pocket depth

    Pocket depth will be measured using periodontal probe

    Time frame: at baseline, 6 and 12 months

07

Study locations

1 of 1 sites recruiting
  • Faculty of Dental Medicine , Al Azhar Univeristy For Girls
    Cairo, Nasr City - Cairo 123456, Egypt
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06721377
Responsible party
Sara Hossam El-din Kadry Othman (Assistant lecturer, Al-Azhar University) — Principal investigator
First posted
Dec 6, 2024
Start date
Sep 1, 2023
Primary completion
Dec 1, 2024
Completion
Jan 1, 2025 (estimated)
Last update
Dec 6, 2024

Study contacts

Sara H Kadry, masters
Contact
Sarra.kadry@miuegypt.edu.eg
02-01226595217
sara H kadry, masters
principal investigator

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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