Endodontically Treated TeethNCT05938400
Impression & Prosthesis Quality Made From Different Polyvinylsiloxane Impression Techniques
A study testing Polyvinylsiloxane impression with different techniques in people with Endodontically Treated Teeth and Missing Teeth, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial summary
This randomized controlled trial is to clinically assess and compare impression quality of polyvinylsiloxane impression material using one step (experimental) and two step (control) impression techniques and its effect on marginal fit of prosthesis and proximal contact of prosthesis. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Endodontically Treated Teeth, Missing Teeth, Discoloration, Tooth
- What is being tested?
- Polyvinylsiloxane impression with different techniques
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Jul 2023to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Indication of fixed-fixed partial denture or crown
- Good oral hygiene
- Sound abutment tooth (vital/non-vital)
Who cannot join
- Failure to provide written consent to participation in study
- Long span bridges (Greater than 3 units)
- Patients with bleeding disorders
- Cases indicated for resin-bonded prosthesis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Impressions Made Using One Step & Two Step Polyvinylsiloxane Impression Techniques and Resulting Fixed Prosthesis-A Randomised Controlled Trial
This randomized controlled trial is to clinically assess and compare impression quality of polyvinylsiloxane impression material using one step (experimental) and two step (control) impression techniques and its effect on marginal fit of prosthesis and proximal contact of prosthesis.
Read the detailed description
Study participants will be randomly allocated to either of the two groups (experimental or control) through software-generated random numbers.
Indicated tooth will be prepared to receive a fixed prosthesis under local anesthesia as per standard guidelines.
Polyvinylsiloxane (PVS) impressions will be recorded in stock tray after moisture control, according to the assigned group.
In experimental group, light body and putty PVS will be mixed simultaneously and placed in stock tray to record impressions in single stage.
In control group, a putty PVS impression will be recorded first in stock tray and allowed to set. After setting of putty PVS, light-bodied PVS material will be applied to recorded impression surface and reseated in mouth to record final impression in second stage.
All impressions will be disinfected according to the recommended guidelines. All impressions will then be assessed by a senior clinician using 3.5 x magnification loupe and graded according to the selected criteria.
Impressions will then be poured in dental stone and prosthesis will be manufactured in dental lab.
Participants will be recalled for prosthesis trial and fit assessment of prosthesis margins using a dental explorer instrument and visual evaluation. Proximal contact of prosthesis will be graded according the criteria and assessed using dental floss.
Satisfactory prostheses will be cemented after final adjustments.
- Conditions
- Endodontically Treated Teeth, Missing Teeth, Discoloration, Tooth, Prosthesis Failure, Dental, Open Margin on Tooth Restoration
- Being tested
- Polyvinylsiloxane impression with different techniques
- Keywords
- Polyvinylsiloxane impression, fixed prosthetics, impression techniques, single stage impression, two step putty wash impression, marginal fit, prosthesis fit, endodontically treated teeth
- Medical subject headings
- Tooth, Nonvital, Anodontia, Tooth Discoloration, Prosthesis Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyvinylsiloxane impression with different techniquesDevice
One step impression technique will be compared with the standard two step technique
| Study group | Role | What they receive |
|---|---|---|
| One step polyvinylsiloxane impression technique | Experimental | All impressions in this group will be recorded in a single stage, mixing light-bodied PVS material and putty PVS material simultaneously and recording of impression of prepared tooth Receives: Device: Polyvinylsiloxane impression with different techniques |
| Two step polyvinylsiloxane impression technique | Active comparator | All impressions in this group will be made in two stages, recording putty PVS impression first and then reloading it with light-bodied PVS material to record final impression. Receives: Device: Polyvinylsiloxane impression with different techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of defects in impression recorded to fabricate dental prosthesis as assessed by impression quality assessment scale
Outcome assessment scale: 1. Perfect impression, no voids or defects; 2. Acceptable impression, minimal defects in non critical region; 3. Unacceptable impression, defects involving critical region.
Measured: 10 minutes
Secondary outcomes (2)
Incidence of prosthesis margin defects as assessed by Marginal adaptation assessment scale
Outcome assessment scale: 1. Adequate, adapted to tooth margins; 2. Inadequate, not accurately adapted to tooth margin
Measured: 14 days
Incidence of prosthesis proximal contact inaccuracy as assessed by prosthesis contact assessment scale
Outcome assessment scale: 1. Acceptable, same as natural proximal contact on contralateral side; 2. Unacceptable; either tight or open proximal contact.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start2 Jul 2023
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endodontically Treated TeethStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Humera Nasim, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05938400
- Sponsor's protocol ID
- 2932
- Status last verified
- Dec 2023
- First submitted
- 25 Mar 2023
- Last updated
- 12 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Impressions Made Using One Step & Two Step Polyvinylsiloxane Impression Techniques and Resulting Fixed Prosthesis-A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05938400
- Acronym / sponsor ID
- 2932
- Conditions
- Endodontically Treated Teeth, Missing Teeth, Discoloration, Tooth, Prosthesis Failure, Dental, Open Margin on Tooth Restoration
- Keywords
- Polyvinylsiloxane impression, fixed prosthetics, impression techniques, single stage impression, two step putty wash impression, marginal fit, prosthesis fit, endodontically treated teeth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 2 Jul 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 10 Jul 2023 (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 randomized controlled trial is to clinically assess and compare impression quality of polyvinylsiloxane impression material using one step (experimental) and two step (control) impression techniques and its effect on marginal fit of prosthesis and proximal contact of prosthesis.
Detailed description
Study participants will be randomly allocated to either of the two groups (experimental or control) through software-generated random numbers.
Indicated tooth will be prepared to receive a fixed prosthesis under local anesthesia as per standard guidelines.
Polyvinylsiloxane (PVS) impressions will be recorded in stock tray after moisture control, according to the assigned group.
In experimental group, light body and putty PVS will be mixed simultaneously and placed in stock tray to record impressions in single stage.
In control group, a putty PVS impression will be recorded first in stock tray and allowed to set. After setting of putty PVS, light-bodied PVS material will be applied to recorded impression surface and reseated in mouth to record final impression in second stage.
All impressions will be disinfected according to the recommended guidelines. All impressions will then be assessed by a senior clinician using 3.5 x magnification loupe and graded according to the selected criteria.
Impressions will then be poured in dental stone and prosthesis will be manufactured in dental lab.
Participants will be recalled for prosthesis trial and fit assessment of prosthesis margins using a dental explorer instrument and visual evaluation. Proximal contact of prosthesis will be graded according the criteria and assessed using dental floss.
Satisfactory prostheses will be cemented after final adjustments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One step polyvinylsiloxane impression technique | Experimental | Device: Polyvinylsiloxane impression with different techniquesAll impressions in this group will be recorded in a single stage, mixing light-bodied PVS material and putty PVS material simultaneously and recording of impression of prepared tooth |
| Two step polyvinylsiloxane impression technique | Active comparator | Device: Polyvinylsiloxane impression with different techniquesAll impressions in this group will be made in two stages, recording putty PVS impression first and then reloading it with light-bodied PVS material to record final impression. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Indication of fixed-fixed partial denture or crown
- Good oral hygiene
- Sound abutment tooth (vital/non-vital)
Key exclusion criteria (4 listed)
- Failure to provide written consent to participation in study
- Long span bridges (Greater than 3 units)
- Patients with bleeding disorders
- Cases indicated for resin-bonded prosthesis
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 |
|---|---|---|
| Polyvinylsiloxane impression with different techniquesOne step impression technique will be compared with the standard two step technique | Device | One step polyvinylsiloxane impression technique, Two step polyvinylsiloxane impression technique |
Primary outcome
Incidence of defects in impression recorded to fabricate dental prosthesis as assessed by impression quality assessment scale
Time frame: 10 minutes
Outcome assessment scale: 1. Perfect impression, no voids or defects; 2. Acceptable impression, minimal defects in non critical region; 3. Unacceptable impression, defects involving critical region.
2 secondary outcomes
Incidence of prosthesis margin defects as assessed by Marginal adaptation assessment scale
Time frame: 14 days
Incidence of prosthesis proximal contact inaccuracy as assessed by prosthesis contact assessment scale
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polyvinylsiloxane impression with different techniques in people with Endodontically Treated Teeth and Missing Teeth, run by Dow University of Health Sciences at 1 site in Pakistan.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of defects in impression recorded to fabricate dental prosthesis as assessed by impression quality assessment scale (time frame: 10 minutes). 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 12 Dec 2023; AzTrials last refreshed its copy on 27 Oct 2026.