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.
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.
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:
- 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:
- Preoperative investigations of the patient were done that included the blood profile (hemoglobin, complete blood (cell) count, bleeding time, clotting time, random blood sugar).
- Preoperative assessment of mandibular bone was done radiographically by cone beam computerized tomography (CBCT).
- Each patient received two dental implants in the canine area bilaterally.
- All implants were placed according to the flapless protocol.
- 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.
- 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.
- The pilot drill is the first twist drill used to create the osteotomy up to the desired length.
- The drills should be repeatedly pumped in and out of the osteotomy to expose the bone debris to the water coolants for clearing.
- A guide pin should be placed in the prepared site to check alignment and parallelism.
- Subsequent drills were used in the same way as the pilot drill to enlarge the osteotomy to the desired depth.
- 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.
- 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.
- 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:
- For each patient in group two, preliminary maxillary and mandibular impressions were made using irreversible hydrocolloid impression material and stock impression trays.
- on custom trays border molding performed by using a thermoplastic compound green sticks.
- The maxillary definitive impressions were made by using a zinc oxide impression material.
- The mandibular definitive impressions were made by direct impression technique with the aid of impression post and laboratory analogue.
- Models were poured with implant analogues; the definitive locator attachment was screwed.
- 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.
- Centric jaw relation was registered. Using face bow, upper cast mounted and then centric relation recorded.
- 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.
- Try-in, processing, finish and polish of the dentures were done.
Digital complete overdenture construction:
- For each patient in group one, preliminary maxillary and mandibular impressions and poured with dental stone in casts and custom trays were fabricated.
- Border molding performed. The maxillary and mandibular definitive impressions were made.
- Models were poured with implant analogues; the definitive locator attachment was screwed.
- Scanning for the model was done to achieve 3D virtual image to the models.
- 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.
- The file of this master scan in STL format transmitted to the CADCAM complete denture provider using a purpose-built software program.
- 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.
- A virtual tooth arrangement was generated for a digital preview.
- The digital preview was evaluated and modified if necessary.
- 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.
- Conditions
- Occlusal Wear of Teeth
- 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 group | Role | What they receive |
|---|---|---|
| 3d Printed implant overdenture | Experimental | patients 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 overdenture | Experimental | patients 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.
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)
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.
- First posted18 Nov 2023
- Study start20 Aug 2022
- Primary completion20 Sep 2022
- Study completion20 Aug 2023
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 Occlusal Wear of TeethStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed shady, Mansoura University
- Investigators
- Mohamed Shady, MD, Principal investigator, Mansoura University Faculty of Dentistry, Prosthodontics department
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Digital Versus Conventional Techniques for Construction of Mandibular Implant Retained Overdenture
- ClinicalTrials.gov ID
- NCT06139003
- Acronym / sponsor ID
- A02060922
- Conditions
- Occlusal Wear of Teeth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 20 Aug 2022 (actual)
- Primary completion
- 20 Sep 2022 (actual)
- Study completion
- 20 Aug 2023 (actual)
- First posted
- 18 Nov 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.
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:
- 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.
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:
- Preoperative investigations of the patient were done that included the blood profile (hemoglobin, complete blood (cell) count, bleeding time, clotting time, random blood sugar).
- Preoperative assessment of mandibular bone was done radiographically by cone beam computerized tomography (CBCT).
- Each patient received two dental implants in the canine area bilaterally.
- All implants were placed according to the flapless protocol.
- 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.
- 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.
- The pilot drill is the first twist drill used to create the osteotomy up to the desired length.
- The drills should be repeatedly pumped in and out of the osteotomy to expose the bone debris to the water coolants for clearing.
- A guide pin should be placed in the prepared site to check alignment and parallelism.
- Subsequent drills were used in the same way as the pilot drill to enlarge the osteotomy to the desired depth.
- 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.
- 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.
- 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:
- For each patient in group two, preliminary maxillary and mandibular impressions were made using irreversible hydrocolloid impression material and stock impression trays.
- on custom trays border molding performed by using a thermoplastic compound green sticks.
- The maxillary definitive impressions were made by using a zinc oxide impression material.
- The mandibular definitive impressions were made by direct impression technique with the aid of impression post and laboratory analogue.
- Models were poured with implant analogues; the definitive locator attachment was screwed.
- 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.
- Centric jaw relation was registered. Using face bow, upper cast mounted and then centric relation recorded.
- 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.
- Try-in, processing, finish and polish of the dentures were done.
Digital complete overdenture construction:
- For each patient in group one, preliminary maxillary and mandibular impressions and poured with dental stone in casts and custom trays were fabricated.
- Border molding performed. The maxillary and mandibular definitive impressions were made.
- Models were poured with implant analogues; the definitive locator attachment was screwed.
- Scanning for the model was done to achieve 3D virtual image to the models.
- 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.
- The file of this master scan in STL format transmitted to the CADCAM complete denture provider using a purpose-built software program.
- 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.
- A virtual tooth arrangement was generated for a digital preview.
- The digital preview was evaluated and modified if necessary.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3d Printed implant overdenture | Experimental | Device: 3d Printed implantpatients will receive maxillary CD and mandibular 2-implant retained overdenture over locator attachment constructed by digital technique. |
| Conventionally constructed implant overdenture | Experimental | Device: Conventionally constructed implantpatients will receive maxillary CD and mandibular 2-implant retained overdenture over locator attachment constructed by conventional technique. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| 3d Printed implantOcclusal stability was evaluated using occlusense device by charting amount and distribution of force over dental arch in percentage | Device | 3d Printed implant overdenture |
| Conventionally constructed implantOcclusal stability was evaluated using occlusense device by charting amount and distribution of force over dental arch in percentage | Device | Conventionally constructed implant overdenture |
Primary outcome
occlusal stability
Time frame: at time of insertion of prosthesis T(0), 6 months after insertion T(6), 12 months after insertion T(12)
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
Occlusal analysis
Time frame: at time of insertion of prosthesis T(0), 6 months after insertion T(6), 12 months after insertion T(12)
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
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 18 Nov 2023.
- Derived from this study: PubMed 40325470Ali 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.
- Individual participant dataSharing planned: No
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Recruiting
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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.
Mohamed Shady, MD principal investigator
Mansoura University Faculty of Dentistry, Prosthodontics department
1 site in 1 country: see every site and its status.
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; AzTrials last refreshed its copy on 6 Nov 2026.