Edentulous JawNCT06376019
Occlusion and Disocclusion Time in Immediately Loaded Overdentures Supported by Two Splinted Versus Non Splinted Interforaminal Implants
A study testing solitary Implant loading with ball attachment, splinted Implant loading with intra oral welding and complete denture in people with Edentulous Jaw, run by Ain Shams University at 1 site in Egypt.
Trial summary
complete denture wearers struggle to eat well with their dentures due to poor denture retention, stability, and occlusal disharmony. So, the current study protocol aims to compare the occlusion/ disocclusion time in immediately loaded implant retained overdentures supported by two interforaminal implants; splinted… Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Edentulous Jaw
- What is being tested?
- solitary Implant loading with ball attachment, splinted Implant loading with intra oral welding and complete denture
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Apr 2024to 15 Sep 2024
- 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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- completely edentulous patients
- non-smokers
- good oral hygiene
- motivated patients
Who cannot join
- major systemic diseases that may affect osseointegration as uncontrolled diabetes mellitus
- the need for extensive bone grafting in planned implant site
- pregnancy
- patients under bisphosphonate treatment
- limited mouth-opening for executing the implant surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Occlusion and Disocclusion Time in Immediately Loaded Implant Supported Overdentures Supported by Two Splinted Versus Non Splinted Interforaminal Implants
complete denture wearers struggle to eat well with their dentures due to poor denture retention, stability, and occlusal disharmony. So, the current study protocol aims to compare the occlusion/ disocclusion time in immediately loaded implant retained overdentures supported by two interforaminal implants; splinted versus non splinted dental implants compared to the conventional complete denture.
Read the detailed description
The gold standard treatment for completely edentulous patients is a removable complete denture, which satisfies patients functional and aesthetic requirements at a low cost. However, the main problem associated with a complete denture is the instability of the complete removable denture, especially the mandibular one. Implant-assisted overdentures over two or three implants are used as a treatment option to increase stability, function, and retention of the denture at a reasonable cost. The immediate loading protocol allows the placement of temporary restoration on the day of implant placement surgery. Pierluigi Mondani pioneered intraoral welding in the early 1970s as an approach to load patients immediately with resin prosthesis and weld titanium implants to a titanium bar in their mouths. The technique of intraoral welding provides rigid splinting in cases of immediate implant loading. Occlusal loads and stability of occlusion are important to consider in the immediate loading of implants to avoid implant biomechanical failures, marginal bone loss, or even complete loss of osseointegration. Quantitative analyzers like t-scans, which are pressure-sensitive films, and virtual technology give a precise method of assessing the sequence of time and occlusal contact force magnitude by converting qualitative data into quantitative parameters. So, the current study protocol aims to compare the occlusion/ disocclusion time in immediately loaded implant retained overdentures supported by two interforaminal implants; splinted versus non splinted dental implants compared to the conventional complete denture.
- Conditions
- Edentulous Jaw
- Being tested
- solitary Implant loading with ball attachment, splinted Implant loading with intra oral welding, complete denture
- Medical subject headings
- Jaw, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
solitary Implant loading with ball attachmentProcedure or surgery
ball attachment will be attached to the dental implant on the day of implant placement
splinted Implant loading with intra oral weldingProcedure or surgery
Titanium bar will be welded to the dental implant on the day of implant placement
complete dentureProcedure or surgery
Mucosa supported conventional complete denture will be fabricated without supporting implants
| Study group | Role | What they receive |
|---|---|---|
| group CD (conventional complete denture group) | Placebo comparator | patients will receive a conventional complete denture with no implant placement Receives: Procedure: complete denture |
| group IB (implant-supported overdenture with ball attachment) | Active comparator | patients will receive an implant-supported overdenture with ball attachment. The overdenture will be relined by a soft liner. Receives: Procedure: solitary Implant loading with ball attachment |
| group II (implant-supported overdenture with an intraoral welded bar) | Active comparator | patients will receive an implant-supported overdenture with an intraoral welded bar. The overdenture will be relined by a soft liner. Receives: Procedure: splinted Implant loading with intra oral welding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of occlusion/disocclusion time
occlusion/disocclusion time will be evaluated using a T scan device
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start25 Apr 2024
- Primary completion15 Aug 2024
- Study completion15 Sep 2024
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 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
- parallel assignment of the participants in ratio 1:1:1 will take place. For allocation concealment, opaque sealed envelopes will be used.
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mostafa Abdelfatah, Ain Shams University
- Investigators
- Ahmed MA Mohamed, BDS MSc MD, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06376019
- Sponsor's protocol ID
- FDASU-RecID11352
- Status last verified
- Aug 2025
- First submitted
- 17 Apr 2024
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Raw statistical data will be available after publishing upon request from the corresponding author
Publications
Refai OM, Abdelfattah Mohamed AM, Ali El-Fiky AM. Evaluation of occlusion and disocclusion time in immediately loaded implant overdentures retained by two splinted versus non-splinted interforaminal implants: A randomized clinical trial. BMC Oral Health. 2026 Jun 22;26(1):1101. doi: 10.1186/s12903-026-08855-w.
PubMed 42332660
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Occlusion and Disocclusion Time in Immediately Loaded Implant Supported Overdentures Supported by Two Splinted Versus Non Splinted Interforaminal Implants
- ClinicalTrials.gov ID
- NCT06376019
- Acronym / sponsor ID
- FDASU-RecID11352
- Conditions
- Edentulous Jaw
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 25 Apr 2024 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 15 Sep 2024 (actual)
- First posted
- 19 Apr 2024 (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.
complete denture wearers struggle to eat well with their dentures due to poor denture retention, stability, and occlusal disharmony. So, the current study protocol aims to compare the occlusion/ disocclusion time in immediately loaded implant retained overdentures supported by two interforaminal implants; splinted versus non splinted dental implants compared to the conventional complete denture.
Detailed description
The gold standard treatment for completely edentulous patients is a removable complete denture, which satisfies patients functional and aesthetic requirements at a low cost. However, the main problem associated with a complete denture is the instability of the complete removable denture, especially the mandibular one. Implant-assisted overdentures over two or three implants are used as a treatment option to increase stability, function, and retention of the denture at a reasonable cost. The immediate loading protocol allows the placement of temporary restoration on the day of implant placement surgery. Pierluigi Mondani pioneered intraoral welding in the early 1970s as an approach to load patients immediately with resin prosthesis and weld titanium implants to a titanium bar in their mouths. The technique of intraoral welding provides rigid splinting in cases of immediate implant loading. Occlusal loads and stability of occlusion are important to consider in the immediate loading of implants to avoid implant biomechanical failures, marginal bone loss, or even complete loss of osseointegration. Quantitative analyzers like t-scans, which are pressure-sensitive films, and virtual technology give a precise method of assessing the sequence of time and occlusal contact force magnitude by converting qualitative data into quantitative parameters. So, the current study protocol aims to compare the occlusion/ disocclusion time in immediately loaded implant retained overdentures supported by two interforaminal implants; splinted versus non splinted dental implants compared to the conventional complete denture.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- parallel assignment of the participants in ratio 1:1:1 will take place. For allocation concealment, opaque sealed envelopes will be used.
| Arm | Type | Receives |
|---|---|---|
| group CD (conventional complete denture group) | Placebo comparator | Procedure: complete denturepatients will receive a conventional complete denture with no implant placement |
| group IB (implant-supported overdenture with ball attachment) | Active comparator | Procedure: solitary Implant loading with ball attachmentpatients will receive an implant-supported overdenture with ball attachment. The overdenture will be relined by a soft liner. |
| group II (implant-supported overdenture with an intraoral welded bar) | Active comparator | Procedure: splinted Implant loading with intra oral weldingpatients will receive an implant-supported overdenture with an intraoral welded bar. The overdenture will be relined by a soft liner. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- completely edentulous patients
- non-smokers
- good oral hygiene
- motivated patients
Key exclusion criteria (5 listed)
- major systemic diseases that may affect osseointegration as uncontrolled diabetes mellitus
- the need for extensive bone grafting in planned implant site
- pregnancy
- patients under bisphosphonate treatment
- limited mouth-opening for executing the implant surgery.
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 |
|---|---|---|
| solitary Implant loading with ball attachmentball attachment will be attached to the dental implant on the day of implant placement | Procedure or surgery | group IB (implant-supported overdenture with ball attachment) |
| splinted Implant loading with intra oral weldingTitanium bar will be welded to the dental implant on the day of implant placement | Procedure or surgery | group II (implant-supported overdenture with an intraoral welded bar) |
| complete dentureMucosa supported conventional complete denture will be fabricated without supporting implants | Procedure or surgery | group CD (conventional complete denture group) |
Primary outcome
Assessment of occlusion/disocclusion time
Time frame: 3 months
occlusion/disocclusion time will be evaluated using a T scan device
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 7 Aug 2025.
- Derived from this study: PubMed 42332660Refai OM, Abdelfattah Mohamed AM, Ali El-Fiky AM. Evaluation of occlusion and disocclusion time in immediately loaded implant overdentures retained by two splinted versus non-splinted interforaminal implants: A randomized clinical trial. BMC Oral Health. 2026 Jun 22;26(1):1101. doi: 10.1186/s12903-026-08855-w.
- Individual participant dataSharing planned: Undecided. Raw statistical data will be available after publishing upon request from the corresponding author
Related trials for Edentulous Jaw
Active, not recruiting
L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
Not yet recruitingObservational study
Digital and Conventional Clasp-retained Partial Dentures (DIGICLASP)
Partial Edentulism
Recruiting
Dynamic vs. Static Jaw Relations in Implant-Supported Prostheses: Chewing Efficiency
Chewing Efficiency in Completely Edentulous Patients Rehabilitated With Implant-Supported Full-Arch Prostheses
Active, not recruiting
Multicenter Study to Evaluate the Clinical Outcome of PrimeTaper EV Implant in Single Tooth Restorations
Jaw, Edentulous, Partially
Recruiting
Clinical and Radiographic Evaluation of UV-Treated Dental Implants With or Without Melatonin in the Upper Posterior Jaw
Jaw, Edentulous, Partially, Bone Resorption
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.
Ahmed MA Mohamed, BDS MSc MD principal investigator
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 solitary Implant loading with ball attachment, splinted Implant loading with intra oral welding and complete denture 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 4 inclusion and 5 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 7 Aug 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?
Assessment of occlusion/disocclusion time (time frame: 3 months). 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 NCT06376019, 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 7 Aug 2025.