Dental Prosthesis ComplicationNCT06082609
Functional Relining Versus Digital Altered Cast Using Digitally Fabricated Distal Extension Frameworks
A study testing Removable partial denture in people with Dental Prosthesis Complication, run by Mansoura University at 1 site in Egypt.
Trial summary
This clinical study will be done to compare between functional relining and digital altered cast of selective pressure impression techniques for constructing mandibular distal extension removable partial dentures using digitally fabricated frameworks by measuring the abutment alveolar bone height changes. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Prosthesis Complication
- What is being tested?
- Removable partial denture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Apr 2023to 16 Dec 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. All patients having completely edentulous maxilla opposing class I Kennedy mandible.
- 2. Sufficient restorative space must be available (from the mucosa covering the crest of the residual ridge to proposed occlusal plane). This will be detected by a tentative jaw relation.
- 3. Well formed residual ridge covered by healthy firm mucosa. 4. All patients are of angel's class I maxillo-mandibular relationships. 5. Abutment teeth must fulfil certain criteria:
- Abutment teeth should be healthy with good periodontal and bone support.
- Should not show a pronounced degree of mobility or advanced gingival recession.
- Crown Root Ratio of abutment teeth not more than 1:2
Who cannot join
- 1. Sever soft tissue undercuts. 2. Systemic diseases that may affect bone changes such as diabetes and osteoporosis.
- 3. History of radiotherapy in the head and neck region.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura University ,Faculty of dentistry
Al Mansurah, Dakahlia Governorate, 35516
About this study
Official title: Functional Relining Versus Digital Altered Cast Of Selective Pressure Impression Techniques Using Digitally Fabricated Distal Extension Frameworks: Abutment Alveolar Bone Height Changes
This clinical study will be done to compare between functional relining and digital altered cast of selective pressure impression techniques for constructing mandibular distal extension removable partial dentures using digitally fabricated frameworks by measuring the abutment alveolar bone height changes.
Read the detailed description
According to the functional impression techniques, all patients will be classified into two equal groups:
Group A: Functional relining of processed RPD base at insertion:
•After try in, a record base will be attached to the minor connectors and metal frameworks using 3D printed master cast.The finished removable partial denture is relined using the functional relining impression technique.
Group B : Digitally obtained altered cast :
Selective pressure impression technique will be made.
Digital altered cast will be done according to J. Wu, Y. Cheng (20) as follow :
All patients will be informed about the follow up and evaluation recalls.
Evaluation of abutment alveolar bone height changes:
Alveolar bone height changes of abutment teeth will be evaluated radiographically at insertion (T0), and after 6 (T6) \& 12 months (T12) after RPD insertion.
- Conditions
- Dental Prosthesis Complication
- Being tested
- Removable partial denture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Removable partial dentureProcedure or surgery
All patients will receive Removable partial denture by two different impression techniques
| Study group | Role | What they receive |
|---|---|---|
| • Group 1 (Functional relining of processed RPD base at insertion) | Active comparator | * After try in, a record base will be attached to the minor connectors and metal frameworks using 3D printed master cast.
* Registration of jaw relation.
* Mounting of master casts on articulator.
* Setting of artificial teeth according to lingualized occlusion principles.
* Try in of RPD.
* Flasking of RPD to obtain mandibular distal extension removable partial dentures.
* The finished removable partial denture is relined using the functional relining impression technique. Receives: Procedure: Removable partial denture |
| • Group 2 (Digitally obtained altered cast ); | Active comparator | 1. Construction of custom tray on metal frame work.
2. Border molding of custom tray.
3. Selective pressure impression technique will be made.
4. Digital altered cast will be done according to J. Wu, Y. Cheng
5. 3D printing of altered master cast that will be used for completing the construction of RPD with the same steps of group (A) but without relining.
* Finally the occlusion of dentures in the two groups will be verified before delivery. Receives: Procedure: Removable partial denture |
What is being measured
The primary outcome is the main question the study is designed to answer.
abutment alveolar bone loss
Alveolar b(one height changes of abutment teeth will be evaluated radiographically at insertion and after one year
Measured: Two year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start10 Apr 2023
- Primary completion20 Apr 2024 (estimated)
- Study completion16 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Prosthesis ComplicationStudies 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
- Model description
- h. According to the functional impression techniques, all patients will be classified into two equal groups: Group A: Functional relining of processed RPD base at insertion Group B : Digitally obtained altered cast
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Sdeek, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06082609
- Sponsor's protocol ID
- A0104023RP
- Status last verified
- Oct 2023
- First submitted
- 4 Sep 2023
- Last updated
- 13 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Relining Versus Digital Altered Cast Of Selective Pressure Impression Techniques Using Digitally Fabricated Distal Extension Frameworks: Abutment Alveolar Bone Height Changes
- ClinicalTrials.gov ID
- NCT06082609
- Acronym / sponsor ID
- A0104023RP
- Conditions
- Dental Prosthesis Complication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- 20 Apr 2024 (estimated)
- Study completion
- 16 Dec 2024 (estimated)
- First posted
- 13 Oct 2023 (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 clinical study will be done to compare between functional relining and digital altered cast of selective pressure impression techniques for constructing mandibular distal extension removable partial dentures using digitally fabricated frameworks by measuring the abutment alveolar bone height changes.
Detailed description
According to the functional impression techniques, all patients will be classified into two equal groups:
Group A: Functional relining of processed RPD base at insertion:
•After try in, a record base will be attached to the minor connectors and metal frameworks using 3D printed master cast.The finished removable partial denture is relined using the functional relining impression technique.
Group B : Digitally obtained altered cast :
Selective pressure impression technique will be made.
Digital altered cast will be done according to J. Wu, Y. Cheng (20) as follow :
All patients will be informed about the follow up and evaluation recalls.
Evaluation of abutment alveolar bone height changes:
Alveolar bone height changes of abutment teeth will be evaluated radiographically at insertion (T0), and after 6 (T6) \& 12 months (T12) after RPD insertion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- h. According to the functional impression techniques, all patients will be classified into two equal groups: Group A: Functional relining of processed RPD base at insertion Group B : Digitally obtained altered cast
| Arm | Type | Receives |
|---|---|---|
| • Group 1 (Functional relining of processed RPD base at insertion) | Active comparator | Procedure: Removable partial denture* After try in, a record base will be attached to the minor connectors and metal frameworks using 3D printed master cast. * Registration of jaw relation. * Mounting of master casts on articulator. * Setting of artificial teeth according to lingualized occlusion principles. * Try in of RPD. * Flasking of RPD to obtain mandibular distal extension removable partial dentures. * The finished removable partial denture is relined using the functional relining impression technique. |
| • Group 2 (Digitally obtained altered cast ); | Active comparator | Procedure: Removable partial denture1. Construction of custom tray on metal frame work. 2. Border molding of custom tray. 3. Selective pressure impression technique will be made. 4. Digital altered cast will be done according to J. Wu, Y. Cheng 5. 3D printing of altered master cast that will be used for completing the construction of RPD with the same steps of group (A) but without relining. * Finally the occlusion of dentures in the two groups will be verified before delivery. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1. All patients having completely edentulous maxilla opposing class I Kennedy mandible.
- 2. Sufficient restorative space must be available (from the mucosa covering the crest of the residual ridge to proposed occlusal plane). This will be detected by a tentative jaw relation.
- 3. Well formed residual ridge covered by healthy firm mucosa. 4. All patients are of angel's class I maxillo-mandibular relationships. 5. Abutment teeth must fulfil certain criteria:
Key exclusion criteria (2 listed)
- 1. Sever soft tissue undercuts. 2. Systemic diseases that may affect bone changes such as diabetes and osteoporosis.
- 3. History of radiotherapy in the head and neck region.
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 |
|---|---|---|
| Removable partial dentureAll patients will receive Removable partial denture by two different impression techniques | Procedure or surgery | • Group 1 (Functional relining of processed RPD base at insertion), • Group 2 (Digitally obtained altered cast ); |
Primary outcome
abutment alveolar bone loss
Time frame: Two year
Alveolar b(one height changes of abutment teeth will be evaluated radiographically at insertion and after one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Removable partial denture in people with Dental Prosthesis Complication, run by Mansoura University 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 6 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 13 Oct 2023. 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?
Results are not available in the source record.
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?
abutment alveolar bone loss (time frame: Two year). 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 13 Oct 2023.