Effect of Certain Denture Disinfectants on Surface Topography, Microhardness and Dimensional Stability of CAD/CAM Milled Polymethyl Methacrylate and Polyether Ether Ketone Denture Base Materials

NCT07672847 | Enrolling By Invitation

• 1 other identifier: DP-01-26-106
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate and compare the influence of different denture cleansing methods using 1% sodium hypochlorite solution, 0.2% chlorhexidine solution and effervescent alkaline peroxide tablet solution -according to manufacturer's instructions- on surface roughness , microhardness and dimensional stability (%) of CAD-CAM Milled both Polymethyl methacrylate and Polyether Ether Ketone denture base materials.

Conditions

Denture; CAD/CAM; Stability; PEEK; PMMA

Keywords

Dimensional Stability; CAD/CAM; Polyether Ether Ketone; PMMA; Topography; Microhardness

Outcome Measures

Primary Outcomes (1)

• Surface Roughness Measurement

  Surface roughness (Ra) was measured using a profilometer. Each specimen was scanned at three random locations, and the mean value was recorded. The device was calibrated using the manufacturer's reference standard prior to each measurement session.

  6 months

Secondary Outcomes (1)

• Microhardness Evaluation

  6 months

Study Arms (8)

M0 group

PLACEBO COMPARATOR

Material used is PMMA Distilled water - control group Disinfection method :Immersed in distilled water at 37 c for 6 months

Other: M0 group

M1 group

EXPERIMENTAL

Material used (PMMA) Type of cleanser: Sodium hypochlorite (NaOCl) Disinfection method :immersed in 1% sodium hypochlorite solution for 6 months

Other: M1 group : PMMA+ Sodium hypochlorite

M2 Group

EXPERIMENTAL

Material: PMMA Type of cleanser :Chlorhexidine (CHX) Disinfection method :Immersed in 0.2% chlorhexidine solution for 6 months

Other: M2 group: PMMA+ Chlorhexidine

M3 group

EXPERIMENTAL

Material used : PMMA Type of cleanser: Effervescent Alkaline Peroxide Tablet Disinfection method :Immersed in Effervescent tablet denture cleanser solution for 6 months

Other: M3 group : PMMA + Effervescent Alkaline Peroxide Tablet

E0 group: (PEEK Control group)

PLACEBO COMPARATOR

Material: PEEK Distilled water : control group Disinfection method: Immersed in distilled water at 37 c for 6 months

Other: E0 group : PEEK control group

E1 group

EXPERIMENTAL

Material : PEEK Type of cleanser :Sodium hypochlorite (NaOCl) Disinfection method :Immersed in 1% sodium hypochlorite solution for 6 months

Other: E1 group : PEEK + Sodium hypochlorite

E2 group

EXPERIMENTAL

Material : PEEK Type of cleanser :Chlorhexidine (CHX) Disinfection method :Immersed in 0.2% chlorhexidine solution for 6 months

Other: E2 group : PEEK +Chlorhexidine group

E3 group

EXPERIMENTAL

Material : PEEK Type of cleanser : Effervescent Alkaline Peroxide Tablet Disinfection method : Immersed in Effervescent tablet denture cleanser solution for 6 months

Other: E3 group: PEEK + Effervescent Alkaline Peroxide Tablet

Interventions

M0 group OTHER

Immersed in distilled water at 37 c for 6 months

M0 group

M1 group : PMMA+ Sodium hypochlorite OTHER

Immersed in 1% sodium hypochlorite solution for 6 months

M1 group

M2 group: PMMA+ Chlorhexidine OTHER

Immersed in 0.2% chlorhexidine solution for 6 months

M2 Group

M3 group : PMMA + Effervescent Alkaline Peroxide Tablet OTHER

Immersed in Effervescent tablet denture cleanser solution for 6 months

M3 group

E0 group : PEEK control group OTHER

Immersed in distilled water at 37 c for 6 months

E0 group: (PEEK Control group)

E1 group : PEEK + Sodium hypochlorite OTHER

Immersed in 1% sodium hypochlorite solution for 6 months

E1 group

E2 group : PEEK +Chlorhexidine group OTHER

Immersed in 0.2% chlorhexidine solution for 6 months

E2 group

E3 group: PEEK + Effervescent Alkaline Peroxide Tablet OTHER

Immersed in Effervescent tablet denture cleanser solution for 6 months

E3 group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Used prefabricated CAD-CAM blocks (PMMA and PEEK, dental grade)
• All specimens milled using standardized CAD-CAM protocols
• Materials from same brand, batch and shade per group
• All specimens polished to a clinical high gloss standard
• Used standardized specimen geometry

You may not qualify if:

• Specimens fabricated using a method other than CAD-CAM milling
• Use blocks from different manufacturer, batches or shades within the same test group
• Use specimens with fabrication defects (visible porosity, cracks, internal voids) or obvious milling errors (tool chattering marks, incomplete milling)
• Specimens with dimensional inaccuracy
• Specimens subjected to incorrect immersion time, temp or concentration of disinfectant
• Use contaminated, not freshly prepared or expired disinfectant solutions

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Menoufia University

Shibīn al Kawm, Egypt

Location

MeSH Terms

Interventions

Sodium Hypochlorite

Intervention Hierarchy (Ancestors)

Hypochlorous Acid; Chlorine Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Demonstrator of Technology of Dental Prosthesis Manufacture

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: June 29, 2026
• Study Start: January 31, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: June 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

EG (1)