Peri-ImplantitisASPISRMSDOMFNCT05960500
All on Six Versus Parallel Implant Distribution for Maxillary Denture Opposing Mandibular All on Four
A study testing implant in people with Peri-Implantitis and Occlusal Trauma, run by Mansoura University at 1 site in Egypt.
Trial summary
Thirty maxillary edentulous patients with previous mandibular All-on-4 screw retained prosthesis and their age ranged from 55 to 65 years were selected from the outpatient clinic, of prosthodontics Department, Faculty of Dentistry, Mansoura University from March 2022 to July2022 and 80% power was used to calculate… Read more about this study
- Who is it for?
- Ages 55 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Peri-Implantitis, Occlusal Trauma, Implant Complication
- What is being tested?
- implant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jun 2022to 15 Jun 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 55 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patient with maxillary edentulous alveolar ridges.
- patient complained from insufficient retention and stability of their maxillary single denture.
Who cannot join
- medically compromised patients.
- patients with parafunctional habits.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: All on Six Versus Parallel Implant Distribution for Screw Retained Maxillary Fixed Single Denture Opposing Mandibular All on Four Implant Distribution
Thirty maxillary edentulous patients with previous mandibular All-on-4 screw retained prosthesis and their age ranged from 55 to 65 years were selected from the outpatient clinic, of prosthodontics Department, Faculty of Dentistry, Mansoura University from March 2022 to July2022 and 80% power was used to calculate patients sample according to the results of a previous study 1 which showed no significant difference was reported when comparing occlusal stability ,implant stability and periimplant soft tissue changes between different implants angulation of both groups. (Effect size=.70mm and α=.05). The power analysis was performed using the G*Power program (version 3.1.5, Kiel, Germany)
Read the detailed description
the aim of this study is to compare between All-on-Six distributed dental implants "Anterior 4 Implant Parallel and Posterior 2 Implant Distally Tilted" versus parallel distribution supporting screw retained maxillary single denture regarding soft tissue changes around implants, implant stability and occlusal stability.
The primary outcome is to study implant stability and occlusal stability. The secondary outcome is to evaluate periimplant soft tissue changes. The null hypothesis of this study will be there is no difference between the two studied groups.All patients were informed about the proposal of this study, the line of treatment, and the need for regular and frequent recalls. Their acceptance to participate in this study was confirmed and they signed the consent form of the ethical committee of the faculty of dentistry. This study gained the approval of the ethical committee of the Faculty of Dentistry, with approval number (A05080622).
all the patients were divided randomly into two equal groups as follows Group I patients received four axially placed anterior Implants(*General system) in lateral and first premolar region and two distally tilted 30 degree posteriorly in molar region relative to the occlusal plane supporting screw retained maxillary single denture.
Group II patients received 6 implants in parallel distribution in anterior, premolar and molar region
- Conditions
- Peri-Implantitis, Occlusal Trauma, Implant Complication
- Being tested
- implant
- Keywords
- soft tissue changes, occlusal stability, implant stability
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implantProcedure or surgery
Also called prothesis
All on six versus parallel implant distribution
| Study group | Role | What they receive |
|---|---|---|
| Six implants in parallel distribution | Active comparator | patients received 6 implants in parallel distribution in anterior, premolar and molar region Receives: Procedure: implant |
| Six implants according to all on six concept | Active comparator | patients recived four axially placed anterior Implants(*General system) in lateral and first premolar region and two distally tilted 30 degree posteriorly in molar region relative to the occlusal plane supporting screw retained maxillary single denture. Receives: Procedure: implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
soft tissue changes around implants
The distance between marginal gingiva and the tip of the probe was measured using a calibrated plastic periodontal probe this distance is considered as pocket depth (PD).Probing depth was evaluated at buccal, lingual, mesial and distal aspect of each implant. using a calibrated pressure sensitive plastic periodontal probe.
Measured: 1 year
Secondary outcomes (2)
occlusal stability
- Evaluation of the the concentration, changes of occlusion and visualization of the masticatory pressure conditions and amount of occlusal wear occured by Digital Occlusal Analyzer System (OccluSense)
Measured: 1 year
implant stability
- Evaluation of the rate of Implant stability A range of PTVs (- 6 to +2) was considered for integrated implants that was measured by periotest device*. The hand piece was. held perpendicular to the long axis of the implants.
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start5 Jun 2022
- Primary completion10 May 2023
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-ImplantitisStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mennat Elrahman Essam Eldeen, Mansoura University
- Investigators
- Mennat Elrahman Essam Eldeen, Phd, Principal investigator, Mansoura university Faculty of Dentistry Prosthodontics Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05960500
- Sponsor's protocol ID
- A05080622
- Acronym
- ASPISRMSDOMF
- Status last verified
- Jul 2023
- First submitted
- 18 Jun 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: . Evaluation was done for all patients at three evaluation periods as follows: T0: immediately before screwing the final prosthesis.T6: 6 months after unscrewing of the final prosthesis.T12: 12 months after unscrewing of the final prosthesis.
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- All on Six Versus Parallel Implant Distribution for Screw Retained Maxillary Fixed Single Denture Opposing Mandibular All on Four Implant Distribution
- ClinicalTrials.gov ID
- NCT05960500
- Acronym / sponsor ID
- ASPISRMSDOMF / A05080622
- Conditions
- Peri-Implantitis, Occlusal Trauma, Implant Complication
- Keywords
- soft tissue changes, occlusal stability, implant stability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 5 Jun 2022 (actual)
- Primary completion
- 10 May 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 25 Jul 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.
Thirty maxillary edentulous patients with previous mandibular All-on-4 screw retained prosthesis and their age ranged from 55 to 65 years were selected from the outpatient clinic, of prosthodontics Department, Faculty of Dentistry, Mansoura University from March 2022 to July2022 and 80% power was used to calculate patients sample according to the results of a previous study 1 which showed no significant difference was reported when comparing occlusal stability ,implant stability and periimplant soft tissue changes between different implants angulation of both groups. (Effect size=.70mm and α=.05). The power analysis was performed using the G*Power program (version 3.1.5, Kiel, Germany)
Detailed description
the aim of this study is to compare between All-on-Six distributed dental implants "Anterior 4 Implant Parallel and Posterior 2 Implant Distally Tilted" versus parallel distribution supporting screw retained maxillary single denture regarding soft tissue changes around implants, implant stability and occlusal stability.
The primary outcome is to study implant stability and occlusal stability. The secondary outcome is to evaluate periimplant soft tissue changes. The null hypothesis of this study will be there is no difference between the two studied groups.All patients were informed about the proposal of this study, the line of treatment, and the need for regular and frequent recalls. Their acceptance to participate in this study was confirmed and they signed the consent form of the ethical committee of the faculty of dentistry. This study gained the approval of the ethical committee of the Faculty of Dentistry, with approval number (A05080622).
all the patients were divided randomly into two equal groups as follows Group I patients received four axially placed anterior Implants(*General system) in lateral and first premolar region and two distally tilted 30 degree posteriorly in molar region relative to the occlusal plane supporting screw retained maxillary single denture.
Group II patients received 6 implants in parallel distribution in anterior, premolar and molar region
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Six implants in parallel distribution | Active comparator | Procedure: implantpatients received 6 implants in parallel distribution in anterior, premolar and molar region |
| Six implants according to all on six concept | Active comparator | Procedure: implantpatients recived four axially placed anterior Implants(*General system) in lateral and first premolar region and two distally tilted 30 degree posteriorly in molar region relative to the occlusal plane supporting screw retained maxillary single denture. |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patient with maxillary edentulous alveolar ridges.
- patient complained from insufficient retention and stability of their maxillary single denture.
Key exclusion criteria (2 listed)
- medically compromised patients.
- patients with parafunctional habits.
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 |
|---|---|---|
| implantAlso: prothesisAll on six versus parallel implant distribution | Procedure or surgery | Six implants according to all on six concept, Six implants in parallel distribution |
Primary outcome
soft tissue changes around implants
Time frame: 1 year
The distance between marginal gingiva and the tip of the probe was measured using a calibrated plastic periodontal probe this distance is considered as pocket depth (PD).Probing depth was evaluated at buccal, lingual, mesial and distal aspect of each implant. using a calibrated pressure sensitive plastic periodontal probe.
2 secondary outcomes
occlusal stability
Time frame: 1 year
implant stability
Time frame: 1year
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 1 Aug 2023.
- Individual participant dataSharing planned: No. . Evaluation was done for all patients at three evaluation periods as follows: T0: immediately before screwing the final prosthesis.T6: 6 months after unscrewing of the final prosthesis.T12: 12 months after unscrewing of the final prosthesis.
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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.
Mennat Elrahman Essam Eldeen, Phd 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 implant in people with Peri-Implantitis and Occlusal Trauma, 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 2 inclusion and 2 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 1 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?
soft tissue changes around implants (time frame: 1 year). 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 1 Aug 2023.