Comparing Impression Techniques for Maxillary Complete Denture Retention

July 4, 2024 updated by: Syed Murtaza Raza Kazmi, Aga Khan University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Kazmi MR Principle investigator, FCPS
  • Phone Number: +923212412423
  • Email: syed.murtaza@aku.edu

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Single step PVS impression
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).
Procedure: Single step PVS impression
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).
Active Comparator: Conventional two-step PVS impression
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.
Procedure: Conventional two-step PVS impression
Border molding with heavy-body PVS first, followed by wash impression with light-body PVS

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
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.
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
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

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of post-insertion visits for denture adjustment
Time Frame: At the end of adjustment period of each denture at an average of 1-month after denture delivery
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

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aga Khan University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 3, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 12, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023-8450-25606

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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