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

March 26, 2025 updated by: Dr. Aiman yaseen, Altamash Institute of Dental Medicine
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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

96

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Control Group (Distilled Water)
Participants (specimens) will receive alginate mixed with distilled water without any disinfectant, serving as the baseline group
Other: Alginate mixed with distilled water
Alginate will be mixed with distilled water only, without any disinfectant additive, to serve as the control for comparison
Experimental: CHX Group (0.2% Chlorhexidine)
Participants (specimens) will receive alginate mixed with 0.2% Chlorhexidine solution to assess its effect on dimensional stability
Other: 0.2% Chlorhexidine + Alginate
Alginate will be mixed with 0.2% Chlorhexidine solution to evaluate its effect on the linear dimensional stability of alginate impressions
Experimental: Chitosan Group (1% Chitosan)
Participants (specimens) will receive alginate mixed with 1% Chitosan solution to evaluate its effect on dimensional stability
Other: 1% Chitosan + Alginate
Alginate will be mixed with 1% Chitosan solution to assess its influence on the linear dimensional stability of alginate impressions
Experimental: Silver Nitrate Group (0.2% Silver Nitrate)
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
Alginate will be mixed with 0.2% Silver Nitrate solution to determine its effect on the dimensional stability of alginate impressions
Experimental: Silver Nanoparticles Group (Green-Synthesized AgNPs)
Participants (specimens) will receive alginate mixed with green-synthesized silver nanoparticles to investigate its impact on dimensional stability
Other: Green-synthesized Silver Nanoparticles + Alginate
Alginate will be mixed with a solution of green-synthesized Silver Nanoparticles to investigate its effect on the dimensional stability of alginate impressions
Experimental: PVP-Iodine Group (15% Povidone-Iodine)
Participants (specimens) will receive alginate mixed with 15% Povidone-Iodine solution to determine its effect on dimensional stability
Other: 15% Povidone-Iodine + Alginate
Alginate will be mixed with 15% Povidone-Iodine solution to analyze its influence on the dimensional stability of alginate impressions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Linear Dimensional Stability of Alginate Impressions
Time Frame: 1 hour after impression making and cast pouring
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Altamash Institute of Dental Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

March 20, 2025

First Submitted That Met QC Criteria

March 26, 2025

First Posted (Actual)

March 28, 2025

Study Record Updates

Last Update Posted (Actual)

March 28, 2025

Last Update Submitted That Met QC Criteria

March 26, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIDM/ERC/10/2024/01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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