Dental DiseasesNCT06366321
Using Digital Technology Versus Conventional Relining Procedure for Correction of Loose Maxillary Complete Denture
A study testing relining technique and CAD/CAM milling technique in people with Dental Diseases and Dental Trauma, run by British University In Egypt at 1 site in Egypt.
Trial summary
This study aimed to evaluate the use of computer added designning / computer added manufacturing (CAD/ CAM ) technology versus conventional relining procedure for treating ill-fitted loose maxillary complete denture and its effect on patient satisfaction, denture retention, and denture adaptation to oral tissues. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Diseases, Dental Trauma, Bone Remodeling Disorder
- What is being tested?
- relining technique and CAD/CAM milling technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with completely edentulous maxillary and mandibular ridges with a normal skeletal relationship (class I) have a moderate-to-highly well-rounded maxillary edentulous ridge without severe undercuts to minimize the effect of undercuts on retention values.
- Patients' main complaint was a loose or "falling" denture, but with proper esthetics, centric relation and the correct vertical dimension of occlusion (VDO).
Who cannot join
- Patients with significant skeletal problems (class II or III) or who went through severe osseous surgery or any hereditary or acquired osseous abnormality find it challenging to place the denture properly on the supporting ridge.
- If the patient suffers from xerostomia, excessive flabby ridges, any pathology of the oral mucosa, or any inflammatory changes, candidiasis, hyperplasia, neurological disorders and malignancies
- If the denture creates a major speech problem, poor esthetics, or an unsatisfactory jaw relationship.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using Digital Technology Versus Conventional Relining Procedure for Correction of Loose Maxillary Complete Denture. Crossover Randomized Control Trial.
This study aimed to evaluate the use of computer added designning / computer added manufacturing (CAD/ CAM ) technology versus conventional relining procedure for treating ill-fitted loose maxillary complete denture and its effect on patient satisfaction, denture retention, and denture adaptation to oral tissues.
Read the detailed description
Twelve edentulous patients suffering from loose maxillary complete dentures were selected, the dentures were adjusted for taking the relining impressions, the impressions were scanned and the STL files were used for milling new dentures (Group A), then the relining impression went through the conventional laboratory steps of processing (Group B). Both groups were evaluated regarding patient's satisfaction by a specially designed questionnaire, retention values were measured by a digital force gauge at denture insertion appointment and two weeks later, finally dentures adaptation to the oral tissues were compared using geomagic software.
- Conditions
- Dental Diseases, Dental Trauma, Bone Remodeling Disorder
- Being tested
- relining technique, CAD/CAM milling technique
- Keywords
- Relining upper denture, Digital denture, Denture Retention, Denture adaptation., CAD/CAM milling
- Medical subject headings
- Stomatognathic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
relining techniqueOther
Also called no other names
construction of complete denture by flasking and casting the relining impression
CAD/CAM milling techniqueOther
Also called computer added designing/ computer added milling
construction of complete denture by milling of the scanned relining impression
| Study group | Role | What they receive |
|---|---|---|
| conventionally constructed denture | Other | construction of complete dentures by conventional (lost wax casting) technique Receives: Other: relining technique |
| digitally constructed denture | Other | construction of complete dentures by digital (CAD/CAM milling) technique Receives: Other: CAD/CAM milling technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient satisfaction using questionnaire
A version of Likert scale with ranges from 1 (completely unsatisfied) to 5 (completely satisfied) was used representing the denture satisfaction scale at denture insertion time and two weeks later regarding denture retention, improved mastication, proper speech, and esthetics.
Patient-based outcomes data were collected. A total satisfaction score was calculated of each item; higher scores mean greater satisfaction.
Measured: two week
denture retention
- An (19-gauge) orthodontic wire in the form of a hook was secured on the center of the palate at a point of intersection of the lines connecting the hamular notches, the right and left canines with the midline by self-cured acrylic resin material and placed on the supporting tissues intraorally.
- Testing procedure: The patient was in an upright position. Digital force gauge (Force Gauge HF- 50N) was linked to the hook and a downward pulled force was applied slowly in a vertical direction opposite to that of the denture path of insertion until the denture was displaced and the highest force value was registered. After completing this procedure three times, the average was determined.
Measured: two weeks
denture adaptation to oral tissues
- Maxillary arches of all patients were scanned using intraoral scanner (3 shape TRIOS 4 wired, Copenhagen, Denmark), fitting surfaces of both denture groups were also scanned using desktop scanner ( 3Shape E2, Copenhagen, Denmark) then A 3D measurement program (Geomagic Control X, 3D Systems, United States) was used to build and superimpose STL files using first initial alignment and then best-fit alignment (fig 7 A\&B). For every measurement point, the root mean square (RMS) (mm) was computed considering both positive and negative values.
- Color map of CAD/CAM milled denture's fitting surface adaptation and of conventionally relined denture's fitting surface adaptation was formed, pressure from the denture fitting surface to the oral tissues is indicated by yellow to red colors. The denture fitting surface and oral tissues are separated by a blue color. Green color denotes that the oral tissues and the denture fitting surface are in contact.
Measured: at the time of denture insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start1 Jan 2024
- Primary completion23 Jan 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental DiseasesStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- British University In Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha kamal, British University In Egypt
- Investigators
- maha kamal, A. Professor, Principal investigator, British University In Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06366321
- Sponsor's protocol ID
- 23-067
- Status last verified
- Apr 2024
- First submitted
- 9 Apr 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kamal MNM. Comparison between relining of ill-fitted maxillary complete denture versus CAD/CAM milling of new one regarding patient satisfaction, denture retention and adaptation. BMC Oral Health. 2025 Jan 4;25(1):18. doi: 10.1186/s12903-024-05298-z.
PubMed 39755611
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Digital Technology Versus Conventional Relining Procedure for Correction of Loose Maxillary Complete Denture. Crossover Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT06366321
- Acronym / sponsor ID
- 23-067
- Conditions
- Dental Diseases, Dental Trauma, Bone Remodeling Disorder
- Keywords
- Relining upper denture, Digital denture, Denture Retention, Denture adaptation., CAD/CAM milling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- British University In EgyptUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 23 Jan 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 15 Apr 2024 (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 study aimed to evaluate the use of computer added designning / computer added manufacturing (CAD/ CAM ) technology versus conventional relining procedure for treating ill-fitted loose maxillary complete denture and its effect on patient satisfaction, denture retention, and denture adaptation to oral tissues.
Detailed description
Twelve edentulous patients suffering from loose maxillary complete dentures were selected, the dentures were adjusted for taking the relining impressions, the impressions were scanned and the STL files were used for milling new dentures (Group A), then the relining impression went through the conventional laboratory steps of processing (Group B). Both groups were evaluated regarding patient's satisfaction by a specially designed questionnaire, retention values were measured by a digital force gauge at denture insertion appointment and two weeks later, finally dentures adaptation to the oral tissues were compared using geomagic software.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventionally constructed denture | Other | Other: relining techniqueconstruction of complete dentures by conventional (lost wax casting) technique |
| digitally constructed denture | Other | Other: CAD/CAM milling techniqueconstruction of complete dentures by digital (CAD/CAM milling) technique |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with completely edentulous maxillary and mandibular ridges with a normal skeletal relationship (class I) have a moderate-to-highly well-rounded maxillary edentulous ridge without severe undercuts to minimize the effect of undercuts on retention values.
- Patients' main complaint was a loose or "falling" denture, but with proper esthetics, centric relation and the correct vertical dimension of occlusion (VDO).
Key exclusion criteria (3 listed)
- Patients with significant skeletal problems (class II or III) or who went through severe osseous surgery or any hereditary or acquired osseous abnormality find it challenging to place the denture properly on the supporting ridge.
- If the patient suffers from xerostomia, excessive flabby ridges, any pathology of the oral mucosa, or any inflammatory changes, candidiasis, hyperplasia, neurological disorders and malignancies
- If the denture creates a major speech problem, poor esthetics, or an unsatisfactory jaw relationship.
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 |
|---|---|---|
| relining techniqueAlso: no other namesconstruction of complete denture by flasking and casting the relining impression | Other | conventionally constructed denture |
| CAD/CAM milling techniqueAlso: computer added designing/ computer added millingconstruction of complete denture by milling of the scanned relining impression | Other | digitally constructed denture |
Primary outcome
patient satisfaction using questionnaire
Time frame: two week
A version of Likert scale with ranges from 1 (completely unsatisfied) to 5 (completely satisfied) was used representing the denture satisfaction scale at denture insertion time and two weeks later regarding denture retention, improved mastication, proper speech, and esthetics. Patient-based outcomes data were collected. A total satisfaction score was calculated of each item; higher scores mean greater satisfaction.
denture retention
Time frame: two weeks
* An (19-gauge) orthodontic wire in the form of a hook was secured on the center of the palate at a point of intersection of the lines connecting the hamular notches, the right and left canines with the midline by self-cured acrylic resin material and placed on the supporting tissues intraorally. * Testing procedure: The patient was in an upright position. Digital force gauge (Force Gauge HF- 50N) was linked to the hook and a downward pulled force was applied slowly in a vertical direction opposite to that of the denture path of insertion until the denture was displaced and the highest force value was registered. After completing this procedure three times, the average was determined.
denture adaptation to oral tissues
Time frame: at the time of denture insertion
* Maxillary arches of all patients were scanned using intraoral scanner (3 shape TRIOS 4 wired, Copenhagen, Denmark), fitting surfaces of both denture groups were also scanned using desktop scanner ( 3Shape E2, Copenhagen, Denmark) then A 3D measurement program (Geomagic Control X, 3D Systems, United States) was used to build and superimpose STL files using first initial alignment and then best-fit alignment (fig 7 A\&B). For every measurement point, the root mean square (RMS) (mm) was computed considering both positive and negative values. * Color map of CAD/CAM milled denture's fitting surface adaptation and of conventionally relined denture's fitting surface adaptation was formed, pressure from the denture fitting surface to the oral tissues is indicated by yellow to red colors. The denture fitting surface and oral tissues are separated by a blue color. Green color denotes that the oral tissues and the denture fitting surface are in contact.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Derived from this study: PubMed 39755611Kamal MNM. Comparison between relining of ill-fitted maxillary complete denture versus CAD/CAM milling of new one regarding patient satisfaction, denture retention and adaptation. BMC Oral Health. 2025 Jan 4;25(1):18. doi: 10.1186/s12903-024-05298-z.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
maha kamal, A. Professor principal investigator
British University In Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing relining technique and CAD/CAM milling technique in people with Dental Diseases and Dental Trauma, run by British University In Egypt at 1 site in Egypt.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 16 Apr 2024. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient satisfaction using questionnaire (time frame: two week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06366321, which also lists 1 linked publication.
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 16 Apr 2024.