Analyzing the Effect of Disinfection Additives on the Linear Dimensional Stability of Dental Alginate Impressions: A Quasi-Experimental Comparative Study

NCT06899672 | Not Yet Recruiting DMC

• 1 other identifier: AIDM/ERC/10/2024/01
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

Brief Summary

This quasi-experimental comparative study investigates the effects of incorporating various self-disinfecting agents-0.2% Chlorhexidine (CHX), 1% Chitosan solution, 0.2% Silver Nitrate (AgNO3), green-synthesized Silver Nanoparticles (AgNPs), and 15% PVP-Iodine-on the linear dimensional stability of dental alginate impressions. Alginate is widely used in dentistry but is prone to dimensional changes and contamination. This study aims to assess whether integrating these disinfectants can reduce microbial risks without compromising the material's dimensional accuracy, thereby improving infection control and the precision of dental prostheses

Conditions

Dimensional Changes

Outcome Measures

Primary Outcomes (1)

• Linear Dimensional Stability of Alginate Impressions

  Measurement of the linear dimensional changes (in millimeters) of alginate impressions mixed with disinfectant additives compared to the control group.

  1 hour after impression making and cast pouring

Study Arms (6)

Control Group (Distilled Water)

EXPERIMENTAL

Participants (specimens) will receive alginate mixed with distilled water without any disinfectant, serving as the baseline group

Other: Alginate mixed with distilled water

CHX Group (0.2% Chlorhexidine)

EXPERIMENTAL

Participants (specimens) will receive alginate mixed with 0.2% Chlorhexidine solution to assess its effect on dimensional stability

Other: 0.2% Chlorhexidine + Alginate

Chitosan Group (1% Chitosan)

EXPERIMENTAL

Participants (specimens) will receive alginate mixed with 1% Chitosan solution to evaluate its effect on dimensional stability

Other: 1% Chitosan + Alginate

Silver Nitrate Group (0.2% Silver Nitrate)

EXPERIMENTAL

Participants (specimens) will receive alginate mixed with 0.2% Silver Nitrate solution to evaluate its effect on dimensional stability

Other: 0.2% Silver Nitrate + Alginate

Silver Nanoparticles Group (Green-Synthesized AgNPs)

EXPERIMENTAL

Participants (specimens) will receive alginate mixed with green-synthesized silver nanoparticles to investigate its impact on dimensional stability

Other: Green-synthesized Silver Nanoparticles + Alginate

PVP-Iodine Group (15% Povidone-Iodine)

EXPERIMENTAL

Participants (specimens) will receive alginate mixed with 15% Povidone-Iodine solution to determine its effect on dimensional stability

Other: 15% Povidone-Iodine + Alginate

Interventions

Alginate mixed with distilled water OTHER

Alginate will be mixed with distilled water only, without any disinfectant additive, to serve as the control for comparison

Control Group (Distilled Water)

0.2% Chlorhexidine + Alginate OTHER

Alginate will be mixed with 0.2% Chlorhexidine solution to evaluate its effect on the linear dimensional stability of alginate impressions

CHX Group (0.2% Chlorhexidine)

1% Chitosan + Alginate OTHER

Alginate will be mixed with 1% Chitosan solution to assess its influence on the linear dimensional stability of alginate impressions

Chitosan Group (1% Chitosan)

0.2% Silver Nitrate + Alginate OTHER

Alginate will be mixed with 0.2% Silver Nitrate solution to determine its effect on the dimensional stability of alginate impressions

Silver Nitrate Group (0.2% Silver Nitrate)

Green-synthesized Silver Nanoparticles + Alginate OTHER

Alginate will be mixed with a solution of green-synthesized Silver Nanoparticles to investigate its effect on the dimensional stability of alginate impressions

Silver Nanoparticles Group (Green-Synthesized AgNPs)

15% Povidone-Iodine + Alginate OTHER

Alginate will be mixed with 15% Povidone-Iodine solution to analyze its influence on the dimensional stability of alginate impressions

PVP-Iodine Group (15% Povidone-Iodine)

Eligibility Criteria

• Age: 60 Minutes+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Dental stone casts free from excessive porosity, fractures, or other visible defects that could affect dimensional stability measurements.
• Typodont models with intact maxillary arch configurations.

You may not qualify if:

• Distorted impressions, under-extended impressions, impressions that detach from the tray before pouring, and impressions with voids, on visual inspection.
• Dental cast with a fracture component, incomplete pouring, and those with voids or bubbles.

Sponsors & Collaborators

• Altamash Institute of Dental Medicine: lead

MeSH Terms

Interventions

Chlorhexidine; Alginates; Chitosan; Silver Nitrate; Povidone-Iodine

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Polysaccharides; Carbohydrates; Chitin; Biopolymers; Polymers; Macromolecular Substances; Nitrates; Nitric Acid; Nitrogen Compounds; Inorganic Chemicals; Silver Compounds; Iodophors; Iodine Compounds; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Bachelor of Dental Surgery

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: March 28, 2025
• Study Start: April 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: October 1, 2025
• Last Updated: March 28, 2025

Record last verified: 2025-03