NCT06116877

Brief Summary

This clinical study will be conducted to evaluate and compare non-modified printable acrylic resin base material and modified printable acrylic resin base material with zirconia oxide nanoparticles for a 2-implant retained complete overdenture regarding:Surface roughness; microbiological assessment of denture base microbiological analysis peri-implant soft tissue health around used implants

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 3, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 3, 2023

Completed
Last Updated

November 3, 2023

Status Verified

October 1, 2023

Enrollment Period

1.1 years

First QC Date

October 31, 2023

Last Update Submit

October 31, 2023

Conditions

Prosthesis Durability

Outcome Measures

Primary Outcomes (3)

  • Surface roughness

    Surface roughness: will be evaluated using profilometer device

    one year

  • Microbiological assessment

    Microbiological assessment of denture base surface microbiological analysis

    one year

  • Peri-implant soft tissue health

    was evaluated using scores for plaque and gingival bleeding

    one year

Study Arms (2)

Group (I) non modified

ACTIVE COMPARATOR

Five patients will receive mandibular 2-implant retained overdentures of non-modified printable acrylic resin base material.

Procedure: implant supported overdenture

Group (II) modified

ACTIVE COMPARATOR

Five patients will receive mandibular 2-implant retained overdentures of modified printable acrylate resin base material with zirconium oxide nanoparticles.

Procedure: implant supported overdenture

Interventions

implant supported overdenturePROCEDURE

mandibular 2-implant retained overdenture of non-modified printable acrylate resins base material with Zirconium oxide nanoparticles

Group (I) non modifiedGroup (II) modified

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Patients are healthy, free from any systemic diseases relating to bone resorption such as uncontrolled diabetics or osteoporosis. This will be achieved through medical history and clinical examination by physician.
  • \. They will have completely edentulous jaws for at least 1 year. 3. They will be of angle's class I maxillo-mandibular relationship and have upper and lower completely edentulous arches.
  • \. Residual alveolar ridges covered with healthy firm mucosa. 5. All included patients will have sufficient available length and width of mandibular bone to accommodate conventional implant. (At least 5 mm buccolingual width and 12 mm vertical height of bone.

You may not qualify if:

  • Patients with chronic systemic diseases that affect bone metabolism
  • Uncontrolled diabetic patients
  • Patients with TMJ dysfunction
  • Smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University ,Faculty of dentistry

Al Mansurah, P.O.Box:35516, Egypt

Location

MeSH Terms

Conditions

Prosthesis Failure

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2023

First Posted

November 3, 2023

Study Start

March 3, 2022

Primary Completion

April 1, 2023

Study Completion

August 11, 2023

Last Updated

November 3, 2023

Record last verified: 2023-10

Locations

EG(1)