An interventional study of Open mouth impression technique and Closed mouth impression technique in Edentulism, sponsored by Watim Medical & Dental College. Not yet recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Watim Medical & Dental College · Not applicable, Interventional, and Treatment
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.
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.
Watim Medical & Dental College is the lead sponsor of 12 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
Final impressions made in custom trays with sectional border molding using low fusing impression compound and a zinc oxide eugenol wash, with the mouth open and no occlusal contact.
Procedure: Open mouth impression technique
Final impressions made in custom trays with attached occlusal rims set to a predetermined vertical dimension. Border molding and the wash impression are made while the patient closes into occlusion and performs functional movements.
Procedure: Closed mouth impression technique
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.
Also known as: Open mouth functional impression, Conventional border molded impression
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.
Also known as: Closed mouth functional impression, Functional impression under occlusal loading
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
Adequate retention of mandibular denture
Kapur index score assessed the same way as the maxillary denture.
Time frame: 6 weeks after denture insertion
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
Plan to share: No — Individual participant data will not be shared publicly to protect participant confidentiality. Summary results will be published in a peer-reviewed journal.
No publications or documents are linked to this record.
Start is estimated for Mar 2027; primary completion for Jun 2027, 3 months later.
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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Watim Medical & Dental College