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Status unknownNCT06082609Updated Oct 13, 2023

Functional Relining Versus Digital Altered Cast Using Digitally Fabricated Distal Extension Frameworks

An interventional study of Removable partial denture in Dental Prosthesis Complication, sponsored by Mansoura University. Status unknown at 1 site in Egypt. Open to participants aged 40 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-13.

Sponsored by Mansoura University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2023), so the status shown — last known as Enrolling by invitation — may be out of date.

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Apr 2023, registered Sep 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
40 Years to 70 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Dental Prosthesis Complication
03

In context

Lead sponsor

Mansoura University is the lead sponsor of 1,115 studies on the registry; 184 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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:

    1. Abutment teeth should be healthy with good periodontal and bone support.
    2. Should not show a pronounced degree of mobility or advanced gingival recession.
    3. Crown Root Ratio of abutment teeth not more than 1:2

Exclusion criteria

Exclusion Criteria:

  • 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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    • Group 1 (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. * 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.

    Procedure: Removable partial denture

  • Active comparator
    • Group 2 (Digitally obtained altered cast );

    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.

    Procedure: Removable partial denture

Interventions

  • ProcedureRemovable partial denture

    All patients will receive Removable partial denture by two different impression techniques

06

What researchers measure

Primary outcomes

  1. abutment alveolar bone loss

    Alveolar b(one height changes of abutment teeth will be evaluated radiographically at insertion and after one year

    Time frame: Two year

07

Study locations

1 site
  • Mansoura University ,Faculty of dentistry
    Al Mansurah, Dakahlia Governorate 35516, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06082609
Responsible party
Asmaa Sdeek (Principal investigator, Mansoura University) — Principal investigator
First posted
Oct 13, 2023
Start date
Apr 10, 2023
Primary completion
Apr 20, 2024 (estimated)
Completion
Dec 16, 2024 (estimated)
Last update
Oct 13, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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