Dimensional ChangesNCT06899672
Analyzing the Effect of Disinfection Additives on the Linear Dimensional Stability of Dental Alginate Impressions: A Quasi-Experimental Comparative Study
A study testing Alginate mixed with distilled water, 0.2% Chlorhexidine + Alginate and 1% Chitosan + Alginate in people with Dimensional Changes, run by Altamash Institute of Dental Medicine.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 minutes and older
- Conditions the study is for
- Dimensional Changes
- What is being tested?
- Alginate mixed with distilled water, 0.2% Chlorhexidine + Alginate and 1% Chitosan + Alginate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2025to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 minutes and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
- Being tested
- Alginate mixed with distilled water, 0.2% Chlorhexidine + Alginate, 1% Chitosan + Alginate, 0.2% Silver Nitrate + Alginate, Green-synthesized Silver Nanoparticles + Alginate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alginate mixed with distilled waterOther
Alginate will be mixed with distilled water only, without any disinfectant additive, to serve as the control for comparison
0.2% Chlorhexidine + AlginateOther
Alginate will be mixed with 0.2% Chlorhexidine solution to evaluate its effect on the linear dimensional stability of alginate impressions
1% Chitosan + AlginateOther
Alginate will be mixed with 1% Chitosan solution to assess its influence on the linear dimensional stability of alginate impressions
0.2% Silver Nitrate + AlginateOther
Alginate will be mixed with 0.2% Silver Nitrate solution to determine its effect on the dimensional stability of alginate impressions
Green-synthesized Silver Nanoparticles + AlginateOther
Alginate will be mixed with a solution of green-synthesized Silver Nanoparticles to investigate its effect on the dimensional stability of alginate impressions
15% Povidone-Iodine + AlginateOther
Alginate will be mixed with 15% Povidone-Iodine solution to analyze its influence on the dimensional stability of alginate impressions
| Study group | Role | What they receive |
|---|---|---|
| Control Group (Distilled Water) | Experimental | Participants (specimens) will receive alginate mixed with distilled water without any disinfectant, serving as the baseline group Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Other: 15% Povidone-Iodine + Alginate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour after impression making and cast pouring
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start1 Apr 2025 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dimensional ChangesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Altamash Institute of Dental Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Aiman yaseen, Altamash Institute of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06899672
- Sponsor's protocol ID
- AIDM/ERC/10/2024/01
- Status last verified
- Mar 2025
- First submitted
- 20 Mar 2025
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analyzing the Effect of Disinfection Additives on the Linear Dimensional Stability of Dental Alginate Impressions: A Quasi-Experimental Comparative Study
- ClinicalTrials.gov ID
- NCT06899672
- Acronym / sponsor ID
- AIDM/ERC/10/2024/01
- Conditions
- Dimensional Changes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Altamash Institute of Dental MedicineUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 28 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Control Group (Distilled Water) | Experimental | Other: Alginate mixed with distilled waterParticipants (specimens) will receive alginate mixed with distilled water without any disinfectant, serving as the baseline group |
| CHX Group (0.2% Chlorhexidine) | Experimental | Other: 0.2% Chlorhexidine + AlginateParticipants (specimens) will receive alginate mixed with 0.2% Chlorhexidine solution to assess its effect on dimensional stability |
| Chitosan Group (1% Chitosan) | Experimental | Other: 1% Chitosan + AlginateParticipants (specimens) will receive alginate mixed with 1% Chitosan solution to evaluate its effect on dimensional stability |
| Silver Nitrate Group (0.2% Silver Nitrate) | Experimental | Other: 0.2% Silver Nitrate + AlginateParticipants (specimens) will receive alginate mixed with 0.2% Silver Nitrate solution to evaluate its effect on dimensional stability |
| Silver Nanoparticles Group (Green-Synthesized AgNPs) | Experimental | Other: Green-synthesized Silver Nanoparticles + AlginateParticipants (specimens) will receive alginate mixed with green-synthesized silver nanoparticles to investigate its impact on dimensional stability |
| PVP-Iodine Group (15% Povidone-Iodine) | Experimental | Other: 15% Povidone-Iodine + AlginateParticipants (specimens) will receive alginate mixed with 15% Povidone-Iodine solution to determine its effect on dimensional stability |
Who may qualify
- Ages
- 60 minutes and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alginate mixed with distilled waterAlginate will be mixed with distilled water only, without any disinfectant additive, to serve as the control for comparison | Other | Control Group (Distilled Water) |
| 0.2% Chlorhexidine + AlginateAlginate will be mixed with 0.2% Chlorhexidine solution to evaluate its effect on the linear dimensional stability of alginate impressions | Other | CHX Group (0.2% Chlorhexidine) |
| 1% Chitosan + AlginateAlginate will be mixed with 1% Chitosan solution to assess its influence on the linear dimensional stability of alginate impressions | Other | Chitosan Group (1% Chitosan) |
| 0.2% Silver Nitrate + AlginateAlginate will be mixed with 0.2% Silver Nitrate solution to determine its effect on the dimensional stability of alginate impressions | Other | Silver Nitrate Group (0.2% Silver Nitrate) |
| Green-synthesized Silver Nanoparticles + AlginateAlginate will be mixed with a solution of green-synthesized Silver Nanoparticles to investigate its effect on the dimensional stability of alginate impressions | Other | Silver Nanoparticles Group (Green-Synthesized AgNPs) |
| 15% Povidone-Iodine + AlginateAlginate will be mixed with 15% Povidone-Iodine solution to analyze its influence on the dimensional stability of alginate impressions | Other | PVP-Iodine Group (15% Povidone-Iodine) |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Alginate mixed with distilled water, 0.2% Chlorhexidine + Alginate and 1% Chitosan + Alginate in people with Dimensional Changes, run by Altamash Institute of Dental Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Linear Dimensional Stability of Alginate Impressions (time frame: 1 hour after impression making and cast pouring). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.