OsteogenesisNCT06358352
Clinical and Radiographic Assessment of PRF Versus Lutein Placement
A study testing Lutein / Zeaxanthin and Platelet rich fibrin in people with Osteogenesis, run by Mansoura University at 1 site in Egypt.
Trial summary
Thirty patients seeking for prosthetic replacement of non-restorable single rooted maxillary teeth by dental implant placement will be selected from the Out-Patient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University. Inclusion criteria: 1. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteogenesis
- What is being tested?
- Lutein / Zeaxanthin and Platelet rich fibrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2021to 1 May 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Badly destructed maxillary single rooted teeth due to trauma or caries.
- Age between 20 and 45 years.
- Good oral hygiene.
- Patients willing to complete the study follow up intervals.
- Patients will be informed about the aim of the study and a written consent will be obtained. The patients have the right to withdraw from the study at any time.
Who cannot join
- periapical infection in the teeth to be replaced.
- Alcohol or drug abuse.
- Patients with systemic diseases that absolutely contraindicate implant placement
- Pregnancy.
- Patients with parafunctional habits (bruxism and clenching)
- Uncooperative patients
- Heavy smokers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Assessment of PRF Versus Lutein Placement Around Immediately Placed Dental Implants
Thirty patients seeking for prosthetic replacement of non-restorable single rooted maxillary teeth by dental implant placement will be selected from the Out-Patient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University.
Inclusion criteria: 1. Badly destructed maxillary single rooted teeth due to trauma or caries. 2. Age between 20 and 45 years. 3. Good oral hygiene. 4. Patients willing to complete the study follow up intervals. 5. Patients will be informed about the aim of the study and a written consent will be obtained. The patients have the right to withdraw from the study at any time.
Read more
Exclusion criteria: 1. periapical infection in the teeth to be replaced. 2. Alcohol or drug abuse. 3. Patients with systemic diseases that absolutely contraindicate implant placement 4. Pregnancy. 5. Patients with parafunctional habits (bruxism and clenching) 6. Uncooperative patients 7. Heavy smokers.
7
Patients grouping: Patients will be randomly divided into three groups:
Group A: Immediate implant placement with leaving the gap distance empty
Group B: Immediate implant placement then placement of PRF around the implant in the gap distance
Group C: Immediate implant placement then placement of lutein around the implant in the gap distance
Clinical evaluation:
Patients will be evaluated clinically for:
1-Postoperative Pain: By using a 10-point Visual Analogue Scale (VAS) for assessment of pain by the patient on the 1st, 3rd, and 7th days after surgery.(10) (0-1=None, 2-4=Mild, 5-7=Moderate, 8-10=Severe) 2. Implant stability Will be assessed at the time of implant insertion and at a period of 3, 6 and 12 months intervals. Resonance frequency analysis (RFA) values expressed as implant stability quotient (ISQ) will be recorded by a transducer attached to the implant by a screw and a frequency response analyzer (Osstell Mentor Device) with the average of 2 measurements performed with the probe in 2 perpendicular directions.
- Sulcus Bleeding Index (SBI) An early sign of gingivitis is bleeding on probing and, in 1971, Muhlemann and Son described the Sulcus Bleeding Index (SBI). It will be assessed at 3, 6 and 12 months intervals.
- Peri-implant probing depth: Depth of the peri-implant sulcus will be made at 3, 6 and 12 months intervals with light force to avoid undue tissue damage and over-extension into the healthy tissue.
Radiographic evaluation:
conebeam CT will be done to evaluate the vertical and horizontal changes to the alveolar bone following immediate implant placement. It will be done immediately after implant placement , after 3 months and after 12 months
- Conditions
- Osteogenesis
- Being tested
- Lutein / Zeaxanthin, Platelet rich fibrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lutein / ZeaxanthinDietary supplement
lutein extract from lutein oral capsules
Platelet rich fibrinBiological
platelet rich fibrin extracted from patient's blood after centrifuging
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Immediate implant placement with leaving the gap distance empty |
| PRF group | Experimental | Immediate implant placement then placement of PRF around the implant in the gap distance Receives: Biological: Platelet rich fibrin |
| lutein group | Experimental | Immediate implant placement then placement of lutein around the implant in the gap distance Receives: Dietary Supplement: Lutein / Zeaxanthin |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone formation
bone formation will be assessed by using conebeam CT
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start1 Oct 2021
- Primary completion1 Feb 2022
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteogenesisStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fakhreldin Hassan Abdel-Rahman, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06358352
- Sponsor's protocol ID
- M18080921
- Status last verified
- Apr 2024
- First submitted
- 5 Apr 2024
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Assessment of PRF Versus Lutein Placement Around Immediately Placed Dental Implants
- ClinicalTrials.gov ID
- NCT06358352
- Acronym / sponsor ID
- M18080921
- Conditions
- Osteogenesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 10 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.
Thirty patients seeking for prosthetic replacement of non-restorable single rooted maxillary teeth by dental implant placement will be selected from the Out-Patient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University.
Inclusion criteria: 1. Badly destructed maxillary single rooted teeth due to trauma or caries. 2. Age between 20 and 45 years. 3. Good oral hygiene. 4. Patients willing to complete the study follow up intervals. 5. Patients will be informed about the aim of the study and a written consent will be obtained. The patients have the right to withdraw from the study at any time.
Exclusion criteria: 1. periapical infection in the teeth to be replaced. 2. Alcohol or drug abuse. 3. Patients with systemic diseases that absolutely contraindicate implant placement 4. Pregnancy. 5. Patients with parafunctional habits (bruxism and clenching) 6. Uncooperative patients 7. Heavy smokers.
7
Patients grouping: Patients will be randomly divided into three groups:
Group A: Immediate implant placement with leaving the gap distance empty
Group B: Immediate implant placement then placement of PRF around the implant in the gap distance
Group C: Immediate implant placement then placement of lutein around the implant in the gap distance
Clinical evaluation:
Patients will be evaluated clinically for:
1-Postoperative Pain: By using a 10-point Visual Analogue Scale (VAS) for assessment of pain by the patient on the 1st, 3rd, and 7th days after surgery.(10) (0-1=None, 2-4=Mild, 5-7=Moderate, 8-10=Severe) 2. Implant stability Will be assessed at the time of implant insertion and at a period of 3, 6 and 12 months intervals. Resonance frequency analysis (RFA) values expressed as implant stability quotient (ISQ) will be recorded by a transducer attached to the implant by a screw and a frequency response analyzer (Osstell Mentor Device) with the average of 2 measurements performed with the probe in 2 perpendicular directions.
- Sulcus Bleeding Index (SBI) An early sign of gingivitis is bleeding on probing and, in 1971, Muhlemann and Son described the Sulcus Bleeding Index (SBI). It will be assessed at 3, 6 and 12 months intervals.
- Peri-implant probing depth: Depth of the peri-implant sulcus will be made at 3, 6 and 12 months intervals with light force to avoid undue tissue damage and over-extension into the healthy tissue.
Radiographic evaluation:
conebeam CT will be done to evaluate the vertical and horizontal changes to the alveolar bone following immediate implant placement. It will be done immediately after implant placement , after 3 months and after 12 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Immediate implant placement with leaving the gap distance empty |
| PRF group | Experimental | Biological: Platelet rich fibrinImmediate implant placement then placement of PRF around the implant in the gap distance |
| lutein group | Experimental | Dietary Supplement: Lutein / ZeaxanthinImmediate implant placement then placement of lutein around the implant in the gap distance |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Badly destructed maxillary single rooted teeth due to trauma or caries.
- Age between 20 and 45 years.
- Good oral hygiene.
- Patients willing to complete the study follow up intervals.
- Patients will be informed about the aim of the study and a written consent will be obtained. The patients have the right to withdraw from the study at any time.
Key exclusion criteria (7 listed)
- periapical infection in the teeth to be replaced.
- Alcohol or drug abuse.
- Patients with systemic diseases that absolutely contraindicate implant placement
- Pregnancy.
- Patients with parafunctional habits (bruxism and clenching)
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 |
|---|---|---|
| Lutein / Zeaxanthinlutein extract from lutein oral capsules | Dietary supplement | lutein group |
| Platelet rich fibrinplatelet rich fibrin extracted from patient's blood after centrifuging | Biological | PRF group |
Primary outcome
bone formation
Time frame: 12 months
bone formation will be assessed by using conebeam CT
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 10 Apr 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lutein / Zeaxanthin and Platelet rich fibrin in people with Osteogenesis, 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 7 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 10 Apr 2024. 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?
bone formation (time frame: 12 months). 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 10 Apr 2024.