EdentulismNCT07832149
Comparison of Open-Mouth and Closed-Mouth Impression Techniques for Complete Dentures
A study testing Open mouth impression technique and Closed mouth impression technique in people with Edentulism, run by Watim Medical & Dental College at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Edentulism
- What is being tested?
- Open mouth impression technique and Closed mouth impression technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 sitePakistan
- Study dates
- Mar 2027to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Department of Prosthodontics, Watim Medical and Dental College, Rawat, Rawalpindi, Punjab, Pakistan
Rawalpindi, Punjab Province, 46000
Fatima Shakeel, BDS, +92 335 8416673, fatimasmir25@gmail.com
About this study
Official title: Comparison of Open Mouth Vs Closed Mouth Edentulous Impression Technique: A Hospital Based Study
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.
Read the detailed description
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.
- Conditions
- Edentulism
- Being tested
- Open mouth impression technique, Closed mouth impression technique
- Keywords
- Complete denture, Open mouth impression technique, Closed mouth impression technique, Denture retention, Kapur index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open mouth impression techniqueProcedure or surgery
Also called Open mouth functional impression, Conventional border molded impression
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 techniqueProcedure or surgery
Also called Closed mouth functional impression, Functional impression under occlusal loading
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Closed mouth impression technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks after denture insertion
Secondary outcomes (2)
Adequate retention of mandibular denture
Kapur index score assessed the same way as the maxillary denture.
Measured: 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.
Measured: 6 weeks after denture insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study startMar 2027 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EdentulismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Watim Medical & Dental College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Fatima Shakeel, Watim Medical & Dental College
- Investigators
- Fatima Shakeel, BDS, Principal investigator, Watim Medical and Dental CollegeZarah Afreen, BDS, FCPS, Study director, Watim Medical and Dental College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07832149
- Sponsor's protocol ID
- WMDC/R&D(ERB)/2025/241
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly to protect participant confidentiality. Summary results will be published in a peer-reviewed journal.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Open Mouth Vs Closed Mouth Edentulous Impression Technique: A Hospital Based Study
- ClinicalTrials.gov ID
- NCT07832149
- Acronym / sponsor ID
- WMDC/R&D(ERB)/2025/241
- Conditions
- Edentulism
- Keywords
- Complete denture, Open mouth impression technique, Closed mouth impression technique, Denture retention, Kapur index
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Watim Medical & Dental CollegeUniversity, hospital or other
- Study start
- Mar 2027 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Open Mouth Technique | Active comparator | Procedure: Open mouth impression techniqueFinal 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. |
| Group B: Closed Mouth Technique | Active comparator | Procedure: Closed mouth impression techniqueFinal 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- Flabby or hypermobile ridges
- Atrophic ridges
- Ridges with bony exostosis
- Active oral pathology
- History of radiotherapy to head and neck
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open mouth impression techniqueAlso: Open mouth functional impression, Conventional border molded impressionSecondary 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. | Procedure or surgery | Group A: Open Mouth Technique |
| Closed mouth impression techniqueAlso: Closed mouth functional impression, Functional impression under occlusal loadingSecondary 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. | Procedure or surgery | Group B: Closed Mouth Technique |
Primary outcome
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.
2 secondary outcomes
Adequate retention of mandibular denture
Time frame: 6 weeks after denture insertion
Patient satisfaction
Time frame: 6 weeks after denture insertion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly to protect participant confidentiality. Summary results will be published in a peer-reviewed journal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fatima Shakeel, BDS principal investigator
Watim Medical and Dental College
Zarah Afreen, BDS, FCPS study director
Watim Medical and Dental College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open mouth impression technique and Closed mouth impression technique in people with Edentulism, run by Watim Medical & Dental College at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fatima Shakeel, BDS (+92 335 8416673, fatimasmir25@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adequate retention of maxillary denture (time frame: 6 weeks after denture insertion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.