Denture RetentionNCT06497621
Comparing Impression Techniques for Maxillary Complete Denture Retention
A study testing Single step PVS impression and Conventional two-step PVS impression in people with Denture Retention and Patient Satisfaction, run by Aga Khan University.
Trial summary
The primary objective of this protocol is to compare retention in maxillary complete dentures using single-versus two-step Poly-vinyl Siloxane (PVS) impressions in edentulous patients at denture delivery. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Denture Retention, Patient Satisfaction
- What is being tested?
- Single step PVS impression and Conventional two-step PVS impression
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 31 Mar 2027
- 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 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with mild to moderately resorbed maxillary alveolar ridge
- Patients with bimaxillary edentulous arches
- Patients aged between 35 to 85 years willing to participate in the study
- Patients who could be available for follow up visits
Who cannot join
- Patients with palatal torus or bony exostoses or severe undercuts in the maxillary arch
- Patients with uncontrolled diabetes, osteoporosis, osteomalacia and osteopenia
- Patients with xerostomia
- Patients with mucosa covering the denture bearing area with signs of inflammation, ulceration, or hyperplasia.
- Patients undergoing radiotherapy or chemotherapy or maxillofacial surgery
- Patients suffering from maxillofacial trauma
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- Patients with neuromuscular disorders
- Patients with clinical signs and symptoms of temporomandibular joint dysfunction
- Patients with highly resorbed maxillary ridge and/ or flabby ridge
- Patient with hypersensitivity to silicone materials
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Two Impression Techniques on Retention of Maxillary Complete Denture in Pakistani Population: A Double-blinded Crossover Randomized Controlled Trial
The primary objective of this protocol is to compare retention in maxillary complete dentures using single-versus two-step Poly-vinyl Siloxane (PVS) impressions in edentulous patients at denture delivery. Secondary objectives include assessing patient satisfaction with impression methods and denture satisfaction after a two-month adaptation and comparing post-delivery adjustment visits.
- Conditions
- Denture Retention, Patient Satisfaction
- Being tested
- Single step PVS impression, Conventional two-step PVS impression
- Keywords
- Crossover, Complete Denture, Retention, Poly-vinyl siloxane
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single step PVS impressionProcedure or surgery
Single-step final impression method for complete denture fabrication using medium body PVS for border molding and wash impression in a single-step (i.e., one insertion of impression tray in mouth).
Conventional two-step PVS impressionProcedure or surgery
Border molding with heavy-body PVS first, followed by wash impression with light-body PVS
| Study group | Role | What they receive |
|---|---|---|
| Single step PVS impression | Experimental | Single-step final impression method for complete denture fabrication using medium body PVS for border molding and wash impression in a single-step (i.e., one insertion of impression tray in mouth). Receives: Procedure: Single step PVS impression |
| Conventional two-step PVS impression | Active comparator | Two-step final impression method for complete denture fabrication, i.e., border molding with heavy-body PVS first, followed by wash impression with light-body PVS. Receives: Procedure: Conventional two-step PVS impression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention of maxillary denture using digital force meter
Three readings will be taken for each maxillary denture using digital force meter, and an average will be calculated in units for Newton (N) or Kg.m/s2.
Measured: At the delivery appointment for each denture at an average of 2.5 week from the start of denture fabrication and at 8th week (+/- 3 days)
Secondary outcomes (2)
Patient satisfaction with impression methods via the Burdens in Dental Impression-Making Questionnaire (BiDIM-Q)
The questionnaire consists of 12 questions covering various aspects of the impression-making process. Prosthodontists will request patients to score each question from 1 to 100 to gauge their response. A higher score for an aspect of the impression-making procedure will indicate a higher degree of satisfaction.
Measured: At the delivery appointment for each denture at an average of 2.5 week from the start of denture fabrication and at 8th week (+/- 3 days)
Denture satisfaction using the Denture Satisfaction (DS) questionnaire.
The questionnaire comprises 11 questions, answered on a 4-point Likert-type scale to assess the patient's experience with the dentures provided.
Measured: At 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start1 Jul 2025 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Denture RetentionStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Syed Murtaza Raza Kazmi, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06497621
- Sponsor's protocol ID
- 2023-8450-25606
- Status last verified
- Jul 2024
- First submitted
- 3 May 2024
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- 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 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Two Impression Techniques on Retention of Maxillary Complete Denture in Pakistani Population: A Double-blinded Crossover Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06497621
- Acronym / sponsor ID
- 2023-8450-25606
- Conditions
- Denture Retention, Patient Satisfaction
- Keywords
- Crossover, Complete Denture, Retention, Poly-vinyl siloxane
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 12 Jul 2024 (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.
The primary objective of this protocol is to compare retention in maxillary complete dentures using single-versus two-step Poly-vinyl Siloxane (PVS) impressions in edentulous patients at denture delivery. Secondary objectives include assessing patient satisfaction with impression methods and denture satisfaction after a two-month adaptation and comparing post-delivery adjustment visits.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single step PVS impression | Experimental | Procedure: Single step PVS impressionSingle-step final impression method for complete denture fabrication using medium body PVS for border molding and wash impression in a single-step (i.e., one insertion of impression tray in mouth). |
| Conventional two-step PVS impression | Active comparator | Procedure: Conventional two-step PVS impressionTwo-step final impression method for complete denture fabrication, i.e., border molding with heavy-body PVS first, followed by wash impression with light-body PVS. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with mild to moderately resorbed maxillary alveolar ridge
- Patients with bimaxillary edentulous arches
- Patients aged between 35 to 85 years willing to participate in the study
- Patients who could be available for follow up visits
Key exclusion criteria (10 listed)
- Patients with palatal torus or bony exostoses or severe undercuts in the maxillary arch
- Patients with uncontrolled diabetes, osteoporosis, osteomalacia and osteopenia
- Patients with xerostomia
- Patients with mucosa covering the denture bearing area with signs of inflammation, ulceration, or hyperplasia.
- Patients undergoing radiotherapy or chemotherapy or maxillofacial surgery
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 |
|---|---|---|
| Single step PVS impressionSingle-step final impression method for complete denture fabrication using medium body PVS for border molding and wash impression in a single-step (i.e., one insertion of impression tray in mouth). | Procedure or surgery | Single step PVS impression |
| Conventional two-step PVS impressionBorder molding with heavy-body PVS first, followed by wash impression with light-body PVS | Procedure or surgery | Conventional two-step PVS impression |
Primary outcome
Retention of maxillary denture using digital force meter
Time frame: At the delivery appointment for each denture at an average of 2.5 week from the start of denture fabrication and at 8th week (+/- 3 days)
Three readings will be taken for each maxillary denture using digital force meter, and an average will be calculated in units for Newton (N) or Kg.m/s2.
2 secondary outcomes
Patient satisfaction with impression methods via the Burdens in Dental Impression-Making Questionnaire (BiDIM-Q)
Time frame: At the delivery appointment for each denture at an average of 2.5 week from the start of denture fabrication and at 8th week (+/- 3 days)
Denture satisfaction using the Denture Satisfaction (DS) questionnaire.
Time frame: At 2 months
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 12 Jul 2024.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Single step PVS impression and Conventional two-step PVS impression in people with Denture Retention and Patient Satisfaction, run by Aga Khan University.
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 4 inclusion and 10 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 12 Jul 2024. 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?
Contact Kazmi MR Principle investigator, FCPS (+923212412423, syed.murtaza@aku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention of maxillary denture using digital force meter (time frame: At the delivery appointment for each denture at an average of 2.5 week from the start of denture fabrication and at 8th week (+/- 3 days)). 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 Jul 2024.