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Occlusal Wear of TeethNCT06139003

Evaluation of Digital Versus Conventional Techniques for Construction of Mandibular Implant Retained Overdenture

A study testing 3d Printed implant and Conventionally constructed implant in people with Occlusal Wear of Teeth, run by Mansoura University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study is to evaluate of two different construction techniques (digital and conventional techniques) for two implant retained complete mandibular overdenture regarding: 1. Digital occlusion stability detection: evaluated by using OccluSense. Read more about this study

Who is it for?
Ages 45 to 60 years, men onlyHealthy volunteers can take part
Conditions the study is for
Occlusal Wear of Teeth
What is being tested?
3d Printed implant and Conventionally constructed implant
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteEgypt
Study dates
20 Aug 2022to 20 Aug 2023
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 45 to 60 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • healthy, free from any systemic diseases relating to bone resorption such as uncontrolled diabetics or osteoporosis.
  • Completely edentulous jaws for at least 1 year.
  • The angle's class I maxillomandibular relationship and have upper and lower completely edentulous arches.
  • Residual alveolar ridges covered with healthy firm mucosa.
  • All included patients' sufficient available length and width of mandibular bone to accommodate conventional implant. (At least 5 mm buccolingual width and 12 mm vertical height of bone).

Who cannot join

  • Patients with systemic diseases that contraindicate implant placement such as hematologic diseases
  • metabolic diseases related to bone resorption such as uncontrolled diabetics or osteoporosis will be also excluded
  • History of para-functional habits (Bruxism, clenching), smoking and alcoholism.
  • History of radiation therapy in the head and neck region.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Mansoura University, Faculty of dentistry

    Al Mansurah

Other trials in Egypt

About this study

The aim of this study is to evaluate of two different construction techniques (digital and conventional techniques) for two implant retained complete mandibular overdenture regarding:

  1. Digital occlusion stability detection: evaluated by using OccluSense.

Evaluation was done in the following evaluation period:

T0: Immediately after over denture insertion. T6: 6 months after over denture insertion. T12: 12 months after over denture insertion.

Read the detailed description

Patient selection and study design:

Six patients who required complete denture were selected from the diagnostic clinic of Prosthodontic Department, Faculty of Dentistry, Mansoura University. All patients were informed about the procedures that was done and a written consent form of ethical committee. All patients had the right to withdraw from the study at any time.

Patients Grouping:

Patients were divided in to 2 equal groups:

Group (I): 3 patients received maxillary CD and mandibular 2-implant retained overdenture constructed by digital technique.

Group (II): 3 patients received maxillary CD and mandibular 2-implant retained overdenture constructed by conventional technique.

Surgical phase procedures:

  1. Preoperative investigations of the patient were done that included the blood profile (hemoglobin, complete blood (cell) count, bleeding time, clotting time, random blood sugar).
  2. Preoperative assessment of mandibular bone was done radiographically by cone beam computerized tomography (CBCT).
  3. Each patient received two dental implants in the canine area bilaterally.
  4. All implants were placed according to the flapless protocol.
  5. A customized surgical stent fabricated according to the preoperative computer based 3D plan and used during the surgical procedure to ensure accurate implant position and angulation.
  6. A small round bur (or Guide drill) the first drill used to make a hole of 1-2 mm deep to create a start point for the pilot drill.
  7. The pilot drill is the first twist drill used to create the osteotomy up to the desired length.
  8. The drills should be repeatedly pumped in and out of the osteotomy to expose the bone debris to the water coolants for clearing.
  9. A guide pin should be placed in the prepared site to check alignment and parallelism.
  10. Subsequent drills were used in the same way as the pilot drill to enlarge the osteotomy to the desired depth.
  11. Profile drills or countersink drills were used to widen the crestal part of the osteotomy to allow the next drill into the osteotomy and to allow the placement of the cover screw without any bony interference.
  12. Osteotomy was performed through the sleeves of the surgical stent and the implants were placed by hand using a torque wrench (35-45 Ncm) through the sleeves. the implant placed 0.5 mm slightly subcrestal, and cover screws were secured using Hex driver.
  13. The dentures were molded to not interfere with the peri-implant tissues and reduce occlusal forces on the implant.

After 3 months of osteointegration period, the implants were exposed, the cover screw was removed and the two healing abutments were screwed into the fixture using their driver for 7 to 10 days.

Each patient received maxillary complete denture against mandibular 2- implant retained complete overdenture with two different construction techniques.

The clinical procedures in the respective visits are described below:

Steps of conventional complete overdenture construction:

  1. For each patient in group two, preliminary maxillary and mandibular impressions were made using irreversible hydrocolloid impression material and stock impression trays.
  2. on custom trays border molding performed by using a thermoplastic compound green sticks.
  3. The maxillary definitive impressions were made by using a zinc oxide impression material.
  4. The mandibular definitive impressions were made by direct impression technique with the aid of impression post and laboratory analogue.
  5. Models were poured with implant analogues; the definitive locator attachment was screwed.
  6. Fabrication of maxillary and mandibular record blocks were done and the labial fullness was established, occlusal plane, and occlusal vertical dimension was recorded and the reference lines (midline and canine line) was marked on the wax rims.
  7. Centric jaw relation was registered. Using face bow, upper cast mounted and then centric relation recorded.
  8. Selection of teeth was done by using the readymade artificial acrylic teeth with lingualized occlusal scheme. And setting of teeth was done with bilateral balanced occlusion.
  9. Try-in, processing, finish and polish of the dentures were done.

Digital complete overdenture construction:

  1. For each patient in group one, preliminary maxillary and mandibular impressions and poured with dental stone in casts and custom trays were fabricated.
  2. Border molding performed. The maxillary and mandibular definitive impressions were made.
  3. Models were poured with implant analogues; the definitive locator attachment was screwed.
  4. Scanning for the model was done to achieve 3D virtual image to the models.
  5. Fabrication of maxillary and mandibular record blocks were done and the labial fullness was established, occlusal plane, and occlusal vertical dimension was recorded and the reference lines (midline and canine line) marked on the wax rims and the resultant data was scanned.
  6. The file of this master scan in STL format transmitted to the CADCAM complete denture provider using a purpose-built software program.
  7. The anatomic landmarks identified, and the peripheral limits marked on a virtual model in the design software, which then was served to design the definitive denture base.
  8. A virtual tooth arrangement was generated for a digital preview.
  9. The digital preview was evaluated and modified if necessary.
  10. Transfer data to a CAM software program, the prostheses printed, finished and polished.

Insertion the prosthesis into the patient's mouth and have them bit down until the resin has cured. Remove the prostheses and trim the excess resin. The prosthesis delivered and patient instructed about the aftercare and recall schedule steps.

Evaluation

Digital occlusal stability detection:

Group I and group II subjected to test by utilization of the Digital Occlusal Analyzer System (OccluSense). The occlusal forces distribution, extent and time sequence can then have recorded: Immediately, 6 and 12 months after denture use.

Being tested
3d Printed implant, Conventionally constructed implant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3d Printed implantDevice

    Occlusal stability was evaluated using occlusense device by charting amount and distribution of force over dental arch in percentage

  • Conventionally constructed implantDevice

    Occlusal stability was evaluated using occlusense device by charting amount and distribution of force over dental arch in percentage

Study groups in NCT06139003
Study groupRoleWhat they receive
3d Printed implant overdentureExperimentalpatients will receive maxillary CD and mandibular 2-implant retained overdenture over locator attachment constructed by digital technique.
Receives: Device: 3d Printed implant
Conventionally constructed implant overdentureExperimentalpatients will receive maxillary CD and mandibular 2-implant retained overdenture over locator attachment constructed by conventional technique.
Receives: Device: Conventionally constructed implant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. occlusal stability

    Using occlusense device to determine distribution of occlusal forces over anterior and posterior areas, right and left side through chart representing areas of occlusal contact

    Measured: at time of insertion of prosthesis T(0), 6 months after insertion T(6), 12 months after insertion T(12)

  2. Occlusal analysis

    Group I and group II will be subjected to test by utilization of the Digital Occlusal Analyzer System (OccluSense) then amount of occlusal force over each unit presented in percentage

    Measured: at time of insertion of prosthesis T(0), 6 months after insertion T(6), 12 months after insertion T(12)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2023
  2. Study start20 Aug 2022
  3. Primary completion20 Sep 2022
  4. Study completion20 Aug 2023

Resources

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
Investigator
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06139003
Sponsor's protocol ID
A02060922
Status last verified
Nov 2023
First submitted
30 Oct 2023
Last updated
18 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ali AEA, Habib A, Shady M. Digital versus conventional techniques for construction of mandibular implant retained overdenture. BMC Oral Health. 2025 May 5;25(1):686. doi: 10.1186/s12903-025-05918-2.

    PubMed 40325470

Questions about this trial

What is this clinical trial studying?

A study testing 3d Printed implant and Conventionally constructed implant in people with Occlusal Wear of Teeth, 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 5 inclusion and 4 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 18 Nov 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?

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?

occlusal stability (time frame: at time of insertion of prosthesis T(0), 6 months after insertion T(6), 12 months after insertion T(12)). The study lists 2 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 NCT06139003, 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 18 Nov 2023.

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