Complete EdentulismNCT05972538
Clinical Performance and Stability of Different Types of Implant Supported Overdenture
A study testing Osstell ( Osstell AB, Goteborg, Sweden)., periodontal probe (Vivacare, TPS, Vivadent, Schaan, Lichtenstein and questionnaire for patient satisfaction in people with Complete Edentulism, run by National Research Centre, Egypt at 1 site in Egypt.
Trial summary
A Total number of 36 implants were installed in 6 patients having mandibular single denture. The patients were divided into two groups according to the definitive prosthesis. Group I received ball and socket retained mandibular implant overdenture while Group II received cement retained implant supported fixed bridges. Read more about this study
- Who is it for?
- Ages 40 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Complete Edentulism
- What is being tested?
- Osstell ( Osstell AB, Goteborg, Sweden)., periodontal probe (Vivacare, TPS, Vivadent, Schaan, Lichtenstein and questionnaire for patient satisfaction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2023to 5 Jul 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 40 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- highly co-operative
- non-smoker
- systemically free from any chronic diseases
Who cannot join
- immunocompromised patients
- patients having knife edge, flat or flabby ridge,
- patients having T. M. J disorders
Trial locations and contacts
1 site in 1 country.
About this study
A Total number of 36 implants were installed in 6 patients having mandibular single denture.
The patients were divided into two groups according to the definitive prosthesis.
Group I received ball and socket retained mandibular implant overdenture while Group II received cement retained implant supported fixed bridges.
Read the detailed description
Implant's stability, clinical performance (gingival index, pocket depth, plaque index and bleeding on probing) and patient's satisfaction were performed after 15, 30,60 and 90 days after prosthesis delivery
- Conditions
- Complete Edentulism
- Being tested
- Osstell ( Osstell AB, Goteborg, Sweden)., periodontal probe (Vivacare, TPS, Vivadent, Schaan, Lichtenstein, questionnaire for patient satisfaction
- Keywords
- Implant stability, Pocket depth, Patient Satisfaction, Overdentures
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osstell ( Osstell AB, Goteborg, Sweden).Device
Implant stability were assessed on 15, 30,60 and 90 days of prosthesis delivery
periodontal probe (Vivacare, TPS, Vivadent, Schaan, LichtensteinDevice
Also called - Assessment of implants clinical performance
Clinical evaluation included assessment of pocket depth, plaque index and bleeding on probing) around the implant abutments on 15, 30,60 and 90 days of prosthesis delivery
questionnaire for patient satisfactionOther
A questionnaire was used to evaluate patient satisfaction on 90 days at the end of follow up period.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | patients received ball and socket retained mandibular implant overdentures restoring complete edentulous mandible. Receives: Device: Osstell ( Osstell AB, Goteborg, Sweden).; Device: periodontal probe (Vivacare, TPS, Vivadent, Schaan, Lichtenstein; Other: questionnaire for patient satisfaction |
| Group II | Experimental | patients received cement retained mandibular implant overdentures restoring complete edentulous mandible. Receives: Device: Osstell ( Osstell AB, Goteborg, Sweden).; Device: periodontal probe (Vivacare, TPS, Vivadent, Schaan, Lichtenstein; Other: questionnaire for patient satisfaction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of change in implant stability
Assessment of implant stability by device ( Ostell device)
Measured: on the 15th, 30th, 60th and 90th days of overdenture insertion
Assessment of change in implants clinical performance throughout the follow-up period.
Assessment of change in pocket depth, plaque index and bleeding on probing) around the implant abutments. by periodontal probe.
Measured: on the 15th, 30th, 60th and 90th days of over denture insertion.
Secondary outcomes (1)
Assessment of patient satisfaction
A questionnaire was used to evaluate patient satisfaction
Measured: on the 90th day of prosthesis delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start1 Apr 2023
- Primary completion1 Jul 2023
- Study completion5 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complete EdentulismStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- two groups.Group I received ball and socket retained mandibular implant overdenture while Group II received cement retained implant supported fixed bridges
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Centre, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Nabil Elboraey, National Research Centre, Egypt
- Investigators
- Asmaa N. Elboraey, Asso, Prof, Principal investigator, National Research Centre, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05972538
- Sponsor's protocol ID
- 64312012023
- Status last verified
- Jul 2023
- First submitted
- 17 Jul 2023
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance and Stability of Different Types of Implant Supported Overdenture
- ClinicalTrials.gov ID
- NCT05972538
- Acronym / sponsor ID
- 64312012023
- Conditions
- Complete Edentulism
- Keywords
- Implant stability, Pocket depth, Patient Satisfaction, Overdentures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- National Research Centre, EgyptUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 5 Jul 2023 (actual)
- First posted
- 2 Aug 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.
A Total number of 36 implants were installed in 6 patients having mandibular single denture.
The patients were divided into two groups according to the definitive prosthesis.
Group I received ball and socket retained mandibular implant overdenture while Group II received cement retained implant supported fixed bridges.
Detailed description
Implant's stability, clinical performance (gingival index, pocket depth, plaque index and bleeding on probing) and patient's satisfaction were performed after 15, 30,60 and 90 days after prosthesis delivery
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- two groups.Group I received ball and socket retained mandibular implant overdenture while Group II received cement retained implant supported fixed bridges
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Device: Osstell ( Osstell AB, Goteborg, Sweden)., Device: periodontal probe (Vivacare, TPS, Vivadent, Schaan, Lichtenstein, Other: questionnaire for patient satisfactionpatients received ball and socket retained mandibular implant overdentures restoring complete edentulous mandible. |
| Group II | Experimental | Device: Osstell ( Osstell AB, Goteborg, Sweden)., Device: periodontal probe (Vivacare, TPS, Vivadent, Schaan, Lichtenstein, Other: questionnaire for patient satisfactionpatients received cement retained mandibular implant overdentures restoring complete edentulous mandible. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- highly co-operative
- non-smoker
- systemically free from any chronic diseases
Key exclusion criteria (3 listed)
- immunocompromised patients
- patients having knife edge, flat or flabby ridge,
- patients having T. M. J disorders
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 |
|---|---|---|
| Osstell ( Osstell AB, Goteborg, Sweden).Implant stability were assessed on 15, 30,60 and 90 days of prosthesis delivery | Device | Group I, Group II |
| periodontal probe (Vivacare, TPS, Vivadent, Schaan, LichtensteinAlso: - Assessment of implants clinical performanceClinical evaluation included assessment of pocket depth, plaque index and bleeding on probing) around the implant abutments on 15, 30,60 and 90 days of prosthesis delivery | Device | Group I, Group II |
| questionnaire for patient satisfactionA questionnaire was used to evaluate patient satisfaction on 90 days at the end of follow up period. | Other | Group I, Group II |
Primary outcome
Assessment of change in implant stability
Time frame: on the 15th, 30th, 60th and 90th days of overdenture insertion
Assessment of implant stability by device ( Ostell device)
Assessment of change in implants clinical performance throughout the follow-up period.
Time frame: on the 15th, 30th, 60th and 90th days of over denture insertion.
Assessment of change in pocket depth, plaque index and bleeding on probing) around the implant abutments. by periodontal probe.
1 secondary outcome
Assessment of patient satisfaction
Time frame: on the 90th day of prosthesis delivery
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 2 Aug 2023.
Related trials for Complete Edentulism
Not yet recruitingObservational study
Russian Version of OHIP-EDENT-19 for Adults With Complete Tooth Loss
Edentulism
Recruiting
Accuracy of Complete-Arch Implant Scans Using Non Calibrated Splinting Scanbodies
Edentulism Complete
Active, not recruiting
Titanium Versus Nano-Carbon CAD/CAM Frameworks for All-on-4 Implant Supported Hybrid Prosthesis.
Complete Edentulism
Not yet recruiting
Comparison of Open-Mouth and Closed-Mouth Impression Techniques for Complete Dentures
Edentulism
Recruiting
Nutritional Intervention for Older Adults With Complete Dentures
Edentulism Complete, Denture, Complete
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.
Asmaa N. Elboraey, Asso, Prof principal investigator
National Research Centre, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osstell ( Osstell AB, Goteborg, Sweden)., periodontal probe (Vivacare, TPS, Vivadent, Schaan, Lichtenstein and questionnaire for patient satisfaction in people with Complete Edentulism, run by National Research Centre, Egypt 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 3 inclusion and 3 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 2 Aug 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?
Assessment of change in implant stability (time frame: on the 15th, 30th, 60th and 90th days of overdenture insertion). 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?
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 2 Aug 2023.