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NCT Number: NCT07832149

Comparison of Open-Mouth and Closed-Mouth Impression Techniques for Complete Dentures

This randomized controlled trial compares two final impression techniques for complete dentures, the open mouth technique and the closed mouth technique. Completely edentulous adults with well-formed ridges will be randomly assigned 1:1 to one of the two techniques. All dentures will be made by a single operator using the same materials and laboratory. Six weeks after insertion, an examiner blinded to group allocation will assess denture retention using the Kapur index, and patient satisfaction will be recorded using a 5-item Likert questionnaire.

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Key information

Conditions

Edentulism

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Prosthodontics, Watim Medical and Dental College, Rawat, Rawalpindi, Punjab, Pakistan

Rawalpindi, Punjab Province, 46000, Pakistan

About this study

In the open mouth group, border molding and the wash impression are made with the patient's mouth open and no occlusal contact. In the closed mouth group, occlusal rims are attached to the custom trays at a predetermined occlusal vertical dimension, and the impression is made while the patient closes and performs functional movements. Jaw relations, try-in, and insertion follow the same protocol for both groups. Retention is scored separately for the maxillary and mandibular dentures, with a score of 2 or 3 counted as adequate. Satisfaction scores range from 5 to 25, and a score of 16 or above counts as satisfied.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults aged 18 to 70 years
  • Completely edentulous in both maxilla and mandible for at least six months, confirmed by clinical examination and orthopantomogram
  • Well-formed ridges, ACP classification Class I or Class II

Exclusion criteria

  • Flabby or hypermobile ridges
  • Atrophic ridges
  • Ridges with bony exostosis
  • Active oral pathology
  • History of radiotherapy to head and neck
  • Uncontrolled systemic disease
  • Neuromuscular or neurological disorders

Treatment and study plan

Open mouth impression technique

Procedure

Secondary impression of the edentulous arch made in a custom acrylic tray. Border molding is done in sections with low fusing impression compound, followed by a zinc oxide eugenol wash impression. The clinician manipulates the tissues and the patient performs functional movements, with the mouth open and no occlusal contact. All steps are done by a single trained operator using the same materials and laboratory as the comparison group.

Other names: Open mouth functional impression, Conventional border molded impression

Closed mouth impression technique

Procedure

Secondary impression made in custom trays with occlusal rims attached and adjusted to a predetermined occlusal vertical dimension. Maxillary and mandibular trays are inserted together. Border molding with low fusing impression compound and a zinc oxide eugenol wash impression are made while the patient closes into occlusion and performs functional movements, recording the denture bearing areas under simulated functional load. All steps are done by a single trained operator using the same materials and laboratory as the comparison group.

Other names: Closed mouth functional impression, Functional impression under occlusal loading

Primary outcomes

  1. Adequate retention of maxillary denture

    Time frame: 6 weeks after denture insertion

    Kapur index score (0 nil, 1 poor, 2 fair, 3 good) assessed by a blinded examiner. A score of 2 or 3 is adequate and 0 or 1 is inadequate.

Secondary outcomes

  1. Adequate retention of mandibular denture

    Time frame: 6 weeks after denture insertion

    Kapur index score assessed the same way as the maxillary denture.

  2. Patient satisfaction

    Time frame: 6 weeks after denture insertion

    5-item Likert questionnaire covering retention, comfort, mastication, phonetics, and overall satisfaction, with a total score of 5 to 25. A score of 16 or above counts as satisfied.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Watim Medical & Dental College

Other

Registry information

Official study title

Comparison of Open Mouth Vs Closed Mouth Edentulous Impression Technique: A Hospital Based Study

Important dates

Study start
2027
Primary completion
2027
Study completion
2027
First posted
Sep 21, 2026
Registry last updated
Sep 23, 2026

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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