Periodontitis, AdultPhase 4NCT05730153
Advanced Platelet-rich Fibrin Combined With Open Debridement in Management of Suprabony Periodontal Defects
A Phase 4 study testing advanced PRF in people with Periodontitis, Adult, run by October University for Modern Sciences and Arts at 1 site in Egypt.
Trial summary
in this clinical trial, patients with periodontal defects will be treated with advanced platelet-rich fibrin in conjunction with open debridement Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Adult
- What is being tested?
- advanced PRF
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Nov 2021to 26 Jul 2022
- Phase
- Phase 4
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients with periodontal suprabony defects.
Who cannot join
- pregnant females.
- smokers.
- systemic disease that contraindicate surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Evaluation of Advanced Platelet Rich Fibrin and Open Debridement in Management of Periodontal Suprabony Defects
in this clinical trial, patients with periodontal defects will be treated with advanced platelet-rich fibrin in conjunction with open debridement
Read the detailed description
two groups of patients with suprabony defects, one will be treated with advanced platelet-rich fibrin in conjunction with open debridement and the other will be treated with open debridement alone. subjects will be evaluated for evidence of bone formation after 6 months of therapy
- Conditions
- Periodontitis, Adult
- Being tested
- advanced PRF
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
advanced PRFBiological
advanced PRF+ surgery
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Active comparator | Not described Receives: Biological: advanced PRF |
| group 2 | Sham comparator | Not described Receives: Biological: advanced PRF |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical evaluation
Rate of probing pocket depth reduction
Measured: 6 months
Secondary outcomes (1)
radiographic evaluation
Rate of bone formation by digital radiography
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start21 Nov 2021
- Primary completion27 Jan 2022
- Study completion26 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontitis, AdultStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- October University for Modern Sciences and Arts
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naglaa Elwakeel, October University for Modern Sciences and Arts
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05730153
- Sponsor's protocol ID
- OMD 3-22
- Status last verified
- Feb 2023
- First submitted
- 7 Feb 2023
- Last updated
- 27 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Advanced Platelet Rich Fibrin and Open Debridement in Management of Periodontal Suprabony Defects
- ClinicalTrials.gov ID
- NCT05730153
- Acronym / sponsor ID
- OMD 3-22
- Conditions
- Periodontitis, Adult
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- October University for Modern Sciences and ArtsUniversity, hospital or other
- Study start
- 21 Nov 2021 (actual)
- Primary completion
- 27 Jan 2022 (actual)
- Study completion
- 26 Jul 2022 (actual)
- First posted
- 15 Feb 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.
in this clinical trial, patients with periodontal defects will be treated with advanced platelet-rich fibrin in conjunction with open debridement
Detailed description
two groups of patients with suprabony defects, one will be treated with advanced platelet-rich fibrin in conjunction with open debridement and the other will be treated with open debridement alone. subjects will be evaluated for evidence of bone formation after 6 months of therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | Active comparator | Biological: advanced PRF |
| group 2 | Sham comparator | Biological: advanced PRF |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients with periodontal suprabony defects.
Key exclusion criteria (3 listed)
- pregnant females.
- smokers.
- systemic disease that contraindicate 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 |
|---|---|---|
| advanced PRFadvanced PRF+ surgery | Biological | group 1, group 2 |
Primary outcome
clinical evaluation
Time frame: 6 months
Rate of probing pocket depth reduction
1 secondary outcome
radiographic evaluation
Time frame: 6 months
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 27 Mar 2023.
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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 Phase 4 study testing advanced PRF in people with Periodontitis, Adult, run by October University for Modern Sciences and Arts 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 1 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 27 Mar 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. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
clinical evaluation (time frame: 6 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 27 Mar 2023.