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NCT Number: NCT06497621

Comparing Impression Techniques for Maxillary Complete Denture Retention

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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Key information

Conditions

Denture Retention Behavior Health Behavior Patient Satisfaction Treatment Adherence and Compliance

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Conventional two-step PVS impression

Procedure

Border molding with heavy-body PVS first, followed by wash impression with light-body PVS

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Other outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kazmi MR Principle investigator, FCPS

CONTACT

[email protected]

+923212412423

Sponsors and collaborators

Lead sponsor

Aga Khan University

Other

Registry information

Official study title

Effect of Two Impression Techniques on Retention of Maxillary Complete Denture in Pakistani Population: A Double-blinded Crossover Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jul 12, 2024
Registry last updated
Jul 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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