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

NCT07832149 | Not Yet Recruiting

• 1 other identifier: WMDC/R&D(ERB)/2025/241
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Edentulism

Keywords

Complete denture; Open mouth impression technique; Closed mouth impression technique; Denture retention; Kapur index

Outcome Measures

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.

  6 weeks after denture insertion

Secondary Outcomes (2)

• Adequate retention of mandibular denture

  6 weeks after denture insertion

• Patient satisfaction

  6 weeks after denture insertion

Study Arms (2)

Group A: Open Mouth Technique

ACTIVE COMPARATOR

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

Group B: Closed Mouth Technique

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: Open mouth functional impression, Conventional border molded impression

Group A: Open Mouth Technique

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.

Also known as: Closed mouth functional impression, Functional impression under occlusal loading

Group B: Closed Mouth Technique

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Watim Medical & Dental College: lead

Study Sites (1)

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

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Study Officials

• Fatima Shakeel, BDS

  Watim Medical and Dental College

  PRINCIPAL INVESTIGATOR

• Zarah Afreen, BDS, FCPS

  Watim Medical and Dental College

  STUDY DIRECTOR

Central Study Contacts

Fatima Shakeel, BDS

CONTACT

+92 335 8416673; fatimasmir25@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The six-week retention assessment is done by an independent examiner blinded to group allocation, and the questionnaire is given by a person not involved in denture fabrication. The operator and the participants are not blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate Resident, Department of Prosthodontics

Study Record Dates

• First Submitted: September 15, 2026
• First Posted: September 21, 2026
• Study Start (Estimated): March 1, 2027
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)