Edentulous JawNCT06965517
Effect of Digital Versus Static Jaw Relation Record on Crestal Bone Changes Around Implants Supporting Maxillary Single Overdenture
A study testing Maxillary implant supported overdenture , Digital jaw relation group and Maxillary implant supported overdenture , Static jaw relation group in people with Edentulous Jaw, run by Ain Shams University at 1 site in Egypt.
Trial summary
patients will be equally and randomly divided into 2 groups. Each group contains seven patients: Digital Group: implant supported maxillary overdenture will be constructed using electronic facebow to record maxillo-mandibular relation. Read more about this study
- Who is it for?
- Ages 35 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Edentulous Jaw
- What is being tested?
- Maxillary implant supported overdenture , Digital jaw relation group and Maxillary implant supported overdenture , Static jaw relation group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Nov 2022to 15 Apr 2025
- 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 35 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: under 60 years.
- Completely edentulous maxillary arch.
- Opposing natural dentition in the mandibular arch.
- Residual mandibular ridge has adequate bone and covered by firm healthy mucosa.
- Class I maxillary-mandibular relationship.
- Normal salivary flow with normal viscosity.
- Systemically free patients.
Who cannot join
- Patients with poor oral hygiene.
- Patients with abnormal oral habits as (bruxism, clenching, tongue thrusting).
- Bone or mucosal diseases.
- Metabolic diseases or uncontrolled diabetes and TMJ disorders.
- Conditions that may complicate the treatment like; large tongue, gagging reflex and limited mouth opening.
- Patients who are smokers.
Trial locations and contacts
1 site in 1 country.
About this study
patients will be equally and randomly divided into 2 groups. Each group contains seven patients: Digital Group: implant supported maxillary overdenture will be constructed using electronic facebow to record maxillo-mandibular relation.
Static Group: implant supported maxillary overdenture will be constructed using the conventional jaw relation method.
Radiographic evaluation for crestal bone height around implants using direct digital periapical paralleling cone technique.
All data of radiographic evaluation were collected and tabulated then statistically analyzed using SPSS software.
Read the detailed description
- Conventional single upper denture will be made for all patients.
- Occlusal adjustment of lower teeth for all patients by T-scan using the single upper conventional denture.
- The single maxillary denture will be duplicated with radiopaque markers and CBCT will be used to determine the exact positions of the implants.
Surgical procedures
- Surgery will be done under local anesthesia.
- Drilling will be carried out under copious sterile irrigation.
- four implants will be inserted in canines and second premolar area in the maxilla.
After 3-4 months of implants placement, patients will be equally and randomly divided into 2 groups. Each group contains seven patients:
Digital group: For this group, implant supported maxillary overdenture will be constructed using electronic facebow to record maxillo-mandibular relation.
Static group: For this group, implant supported maxillary overdenture will be constructed using the conventional jaw relation method.
Post insertion:
- Clinical evaluation for any signs of inflammation is made.
- Further occlusal refining of lower teeth by T-scan is done with final overdenture.
Method of evaluation:
Radiographic evaluation for crestal bone height around implants using direct digital periapical paralleling cone technique.
All data of radiographic evaluation were collected and tabulated then statistically analyzed using SPSS software.
- Conditions
- Edentulous Jaw
- Being tested
- Maxillary implant supported overdenture , Digital jaw relation group, Maxillary implant supported overdenture , Static jaw relation group
- Medical subject headings
- Jaw, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maxillary implant supported overdenture , Digital jaw relation groupProcedure or surgery
implant supported maxillary overdenture constructed using electronic facebow to record maxillo-mandibular relation.
Maxillary implant supported overdenture , Static jaw relation groupProcedure or surgery
implant supported maxillary overdenture constructed using the conventional jaw relation method.
| Study group | Role | What they receive |
|---|---|---|
| Digital group | Active comparator | implant supported maxillary overdenture constructed using electronic facebow to record maxillo-mandibular relation. Receives: Procedure: Maxillary implant supported overdenture , Digital jaw relation group |
| Static group | Placebo comparator | implant supported maxillary overdenture constructed using the conventional jaw relation method Receives: Procedure: Maxillary implant supported overdenture , Static jaw relation group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal bone loss around implants
Crestal bone changes around implants supporting maxillary single overdenture opposed by natural dentition were measured using periapical radiography through long cone technique
Measured: 18 month
Secondary outcomes (1)
digital occlusal analysis using T-scan
Immediately after implant overdenture insertion, occlusal force magnitude, time and equilibrium were measured by the T-scan digital system by instructing the patient to bite on a sensor attached to a laptop on which the biting force was displayed as a count of disocclusion time and occlusion time, dictating the degree of any occlusal interference. The system also shows the degree of centralization of biting force between the right and left sides of the arch.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study start30 Nov 2022
- Primary completion1 Jan 2025
- Study completion15 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous JawStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Model description
- 4 implants inserted in fully edentulous maxilla, then loading with ball abutments for maxillary overdenture
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lamiaa Gouda Al-Shahier B-Eid AbdelMonem Saleh, Ain Shams University
- Investigators
- Lamiaa GA Saleh, BSc, MSc, Principal investigator, Faculty of Dentistry, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06965517
- Sponsor's protocol ID
- FDASU-RecID022140
- Status last verified
- Nov 2023
- First submitted
- 15 Apr 2025
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: a data availability statement will be provided in the article going to be published indicating that data will be available upon reasonable request from the principle investigator
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Digital Versus Static Jaw Relation Record on Crestal Bone Changes Around Implants Supporting Maxillary Single Overdenture
- ClinicalTrials.gov ID
- NCT06965517
- Acronym / sponsor ID
- FDASU-RecID022140
- Conditions
- Edentulous Jaw
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 15 Apr 2025 (actual)
- First posted
- 11 May 2025 (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.
patients will be equally and randomly divided into 2 groups. Each group contains seven patients: Digital Group: implant supported maxillary overdenture will be constructed using electronic facebow to record maxillo-mandibular relation.
Static Group: implant supported maxillary overdenture will be constructed using the conventional jaw relation method.
Radiographic evaluation for crestal bone height around implants using direct digital periapical paralleling cone technique.
All data of radiographic evaluation were collected and tabulated then statistically analyzed using SPSS software.
Detailed description
- Conventional single upper denture will be made for all patients.
- Occlusal adjustment of lower teeth for all patients by T-scan using the single upper conventional denture.
- The single maxillary denture will be duplicated with radiopaque markers and CBCT will be used to determine the exact positions of the implants.
Surgical procedures
- Surgery will be done under local anesthesia.
- Drilling will be carried out under copious sterile irrigation.
- four implants will be inserted in canines and second premolar area in the maxilla.
After 3-4 months of implants placement, patients will be equally and randomly divided into 2 groups. Each group contains seven patients:
Digital group: For this group, implant supported maxillary overdenture will be constructed using electronic facebow to record maxillo-mandibular relation.
Static group: For this group, implant supported maxillary overdenture will be constructed using the conventional jaw relation method.
Post insertion:
- Clinical evaluation for any signs of inflammation is made.
- Further occlusal refining of lower teeth by T-scan is done with final overdenture.
Method of evaluation:
Radiographic evaluation for crestal bone height around implants using direct digital periapical paralleling cone technique.
All data of radiographic evaluation were collected and tabulated then statistically analyzed using SPSS software.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 4 implants inserted in fully edentulous maxilla, then loading with ball abutments for maxillary overdenture
| Arm | Type | Receives |
|---|---|---|
| Digital group | Active comparator | Procedure: Maxillary implant supported overdenture , Digital jaw relation groupimplant supported maxillary overdenture constructed using electronic facebow to record maxillo-mandibular relation. |
| Static group | Placebo comparator | Procedure: Maxillary implant supported overdenture , Static jaw relation groupimplant supported maxillary overdenture constructed using the conventional jaw relation method |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age: under 60 years.
- Completely edentulous maxillary arch.
- Opposing natural dentition in the mandibular arch.
- Residual mandibular ridge has adequate bone and covered by firm healthy mucosa.
- Class I maxillary-mandibular relationship.
Key exclusion criteria (6 listed)
- Patients with poor oral hygiene.
- Patients with abnormal oral habits as (bruxism, clenching, tongue thrusting).
- Bone or mucosal diseases.
- Metabolic diseases or uncontrolled diabetes and TMJ disorders.
- Conditions that may complicate the treatment like; large tongue, gagging reflex and limited mouth opening.
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 |
|---|---|---|
| Maxillary implant supported overdenture , Digital jaw relation groupimplant supported maxillary overdenture constructed using electronic facebow to record maxillo-mandibular relation. | Procedure or surgery | Digital group |
| Maxillary implant supported overdenture , Static jaw relation groupimplant supported maxillary overdenture constructed using the conventional jaw relation method. | Procedure or surgery | Static group |
Primary outcome
Marginal bone loss around implants
Time frame: 18 month
Crestal bone changes around implants supporting maxillary single overdenture opposed by natural dentition were measured using periapical radiography through long cone technique
1 secondary outcome
digital occlusal analysis using T-scan
Time frame: 1 year
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 11 May 2025.
- Individual participant dataSharing planned: Yes. a data availability statement will be provided in the article going to be published indicating that data will be available upon reasonable request from the principle investigator
Related trials for Edentulous Jaw
Not yet recruitingObservational study
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Dynamic vs. Static Jaw Relations in Implant-Supported Prostheses: Chewing Efficiency
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Active, not recruiting
Multicenter Study to Evaluate the Clinical Outcome of PrimeTaper EV Implant in Single Tooth Restorations
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Clinical and Radiographic Evaluation of UV-Treated Dental Implants With or Without Melatonin in the Upper Posterior Jaw
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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.
Lamiaa GA Saleh, BSc, MSc principal investigator
Faculty of Dentistry, Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maxillary implant supported overdenture , Digital jaw relation group and Maxillary implant supported overdenture , Static jaw relation group in people with Edentulous Jaw, run by Ain Shams 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 7 inclusion and 6 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 11 May 2025. 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. Some participants in this study may receive a placebo. 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?
Marginal bone loss around implants (time frame: 18 month). 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 11 May 2025.