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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single step PVS impression | Procedure | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of post-insertion visits for denture adjustment | The research team will record the post-delivery visits required to adjust dentures fabricated from two different impression methods in the study Pro-forma. | At the end of adjustment period of each denture at an average of 1-month after denture delivery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kazmi MR Principle investigator, FCPS | Contact | +923212412423 | syed.murtaza@aku.edu |
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| ID | Term |
|---|---|
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| Conventional two-step PVS impression | Procedure | Border molding with heavy-body PVS first, followed by wash impression with light-body PVS |
|
| 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. | At 2 months |