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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Open mouth impression technique
Procedure/SurgerySecondary 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/SurgerySecondary 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
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Adequate retention of mandibular denture
Kapur index score assessed the same way as the maxillary denture.
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.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: