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CompletedNCT06139003Updated Nov 18, 2023

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

An interventional study of 3d Printed implant and Conventionally constructed implant in Occlusal Wear of Teeth, sponsored by Mansoura University. Completed at 1 site in Egypt. Open to male participants aged 45 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-18.

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

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Aug 2022, registered Oct 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
45 Years to 60 Years
Sex
Male
01

Study 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.

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.
  1. The mandibular definitive impressions were made by direct impression technique with the aid of impression post and laboratory analogue.
  1. Models were poured with implant analogues; the definitive locator attachment was screwed.
  1. 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.
  1. Centric jaw relation was registered. Using face bow, upper cast mounted and then centric relation recorded.
  1. 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.
  1. 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.

02

Conditions studied

  • Occlusal Wear of Teeth

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03

In context

Tooth Attrition

14 studies on the registry are indexed under Tooth Attrition; 5 are open to participants now.

This study's enrollment of 20 is below the median of 26 across 11 interventional studies indexed under Tooth Attrition.

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Lead sponsor

Mansoura University is the lead sponsor of 1,119 studies on the registry; 183 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
45 Years to 60 Years
Sexes eligible
Male
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

  • 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).

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    3d Printed implant overdenture

    patients will receive maxillary CD and mandibular 2-implant retained overdenture over locator attachment constructed by digital technique.

    Device: 3d Printed implant

  • Experimental
    Conventionally constructed implant overdenture

    patients will receive maxillary CD and mandibular 2-implant retained overdenture over locator attachment constructed by conventional technique.

    Device: Conventionally constructed implant

Interventions

  • Device3d Printed implant

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

  • DeviceConventionally constructed implant

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

06

What researchers measure

Primary outcomes

  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

    Time frame: 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

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

07

Study locations

1 site
  • Mansoura University, Faculty of dentistry
    Mansoura, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2022 to primary completion in Sep 2022, 1 month.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 30, 2023
First posted
Nov 18, 2023
StartActual
Aug 20, 2022
Primary completionActual
Sep 20, 2022
CompletionActual
Aug 20, 2023
Last update
Nov 18, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06139003
Responsible party
Mohamed shady (principle investigator, Mansoura University) — Principal investigator
First posted
Nov 18, 2023
Start date
Aug 20, 2022
Primary completion
Sep 20, 2022
Completion
Aug 20, 2023
Last update
Nov 18, 2023

Study contacts

Mohamed Shady, MD
principal investigator · Mansoura University Faculty of Dentistry, Prosthodontics department

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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