NCT06395116

Brief Summary

Polymethylmethacrylate (PMMA) has been the material of choice for fabricating complete dentures for more than 80 years now.(1,2) As a material it is easy to handle and can be easily repaired and polished. PMMA while being a low-cost material has good esthetics. Some disadvantages of PMMA as a material are surface roughness and porosities which lead to staining, plaque accumulation and bacterial adhesion over time. Among the various factors that can influence microbial attachment to surfaces, surface roughness, hydrophilicity and free surface energy of PMMA are most important. Carboxylate and methyl ester groups found in PMMA make it a very hydrophilic material with a large amount of free surface energy. Despite the influence of the chemical composition, processing methods play the most important role in developing surface roughness.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2023

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 29, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 4, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2024

Completed
Last Updated

May 1, 2024

Status Verified

April 1, 2024

Enrollment Period

1.5 years

First QC Date

April 29, 2024

Last Update Submit

April 29, 2024

Conditions

Keywords

Microbial adhesion, Biofilm formation, Denture base

Outcome Measures

Primary Outcomes (1)

  • Biofilm formation

    such as Candida Albian's and Staphylococcus Aureus colonies per ml

    3 years

Study Arms (3)

Conventionl self cure acrylic group

Constructed from heat cured acrylic resin

Other: Denture base material

3D printed acrylis resin group

Manufactured by additive manufacturing technique

Other: Denture base material

Milled acrylic resin group

Manufactured by milled technique

Other: Denture base material

Interventions

Denture base material constructed with different techniques for completely edentulous populations

3D printed acrylis resin groupConventionl self cure acrylic groupMilled acrylic resin group

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Completely edentulous population who attended at the faculty of Dentistry, Menoufia University

You may qualify if:

  • Completely edentulous populations.
  • Good physical and mental health.
  • No systemic disease

You may not qualify if:

  • Partially edentulous populations.
  • Patients with smoking more than 10 citrates day.
  • Patients with systemic diseases.
  • Patients undergrown radiotherapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohammed A. El-Sawy

Al Mansurah, 12345, Egypt

Location

MeSH Terms

Conditions

Communicable DiseasesStomatitis, Denture

Condition Hierarchy (Ancestors)

InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsStomatitisMouth DiseasesStomatognathic Diseases

Study Officials

  • Mohammed A. El-Sawy, PhD

    Menoufia University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer, Department of prosthodontics, principle investigator

Study Record Dates

First Submitted

April 29, 2024

First Posted

May 1, 2024

Study Start

January 20, 2023

Primary Completion

July 4, 2024

Study Completion

September 5, 2024

Last Updated

May 1, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Only with permission from the corresponding author

Locations