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

ConditionEdentulism
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorWatim Medical & Dental College

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Flabby or hypermobile ridges

Atrophic ridges

Ridges with bony exostosis

Active oral pathology

Trial design

Design model

Parallel

Treatments tested in this trial

  • Open mouth impression technique

    Procedure/Surgery

    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.

  • Closed mouth impression technique

    Procedure/Surgery

    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.

Treatment groups

88 Participants
are divided into 2 treatment groups
Group A: Group A: Open Mouth TechniqueActive comparator 1 intervention
Group B: Group B: Closed Mouth TechniqueActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Adequate retention of maxillary denture

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.

Time frame
6 weeks after denture insertion

Secondary outcomes

1

Adequate retention of mandibular denture

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

Time frame
6 weeks after denture insertion
2

Patient satisfaction

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.

Time frame
6 weeks after denture insertion

Other outcomes

Sponsors and contacts

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