Periodontitis Stage IIPhase 4NCT07316582
Melatonin Loaded in Injectable Platelet-Rich Fibrin in the Management Periodontitis
A Phase 4 study testing Melatonin-Loaded Injectable Platelet-Rich Fibrin and injectible platelet rich fibrin (i-PRF ) in people with Periodontitis Stage II, run by Al-Azhar University at 1 site in Egypt.
Trial summary
melatonin loaded in injectible platelet rich fibrin in treatment of periodontitis Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis Stage II
- What is being tested?
- Melatonin-Loaded Injectable Platelet-Rich Fibrin and injectible platelet rich fibrin (i-PRF )
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2025to 1 Jul 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Diagnosed with stage II periodontitis based on AAP/EFP 2018 classification
- Minimum of two non-adjacent periodontal pockets <5 mm in different quadrants
- Systemically healthy individuals willing to participate and comply with follow-up visits
- Radiographic bone loss (ranged from is 10-20% mostly horizontal
Who cannot join
- History of systemic diseases affecting periodontium (e.g., diabetes, osteoporosis)
- Use of antibiotics, anti-inflammatories, or antioxidant supplements in the past 3 months
- Smoking or tobacco use
- Pregnancy or lactation
- Allergy to melatonin or related compounds
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical and Biochemical Evaluation of Melatonin Loaded in Injectable Platelet-Rich Fibrin in the Management of Stage II Grade A Periodontitis: A Randomized Controlled Clinical Trial
melatonin loaded in injectible platelet rich fibrin in treatment of periodontitis
- Conditions
- Periodontitis Stage II
- Being tested
- Melatonin-Loaded Injectable Platelet-Rich Fibrin, injectible platelet rich fibrin (i-PRF )
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin-Loaded Injectable Platelet-Rich FibrinDrug
patients will be included in this group receiving SRP with Melatonin loaded in (I-PRF) using insulin syringe for injection
injectible platelet rich fibrin (i-PRF )Biological
patients will be included in this group receiving (SRP) with local application of i-PRF
| Study group | Role | What they receive |
|---|---|---|
| Scaling and Root Planning only | No intervention | Mechanical removal of supra- and subgingival plaque and calculus using ultrasonic and hand instruments. |
| Injectable Platelet-Rich Fibrin (i-PRF) | Placebo comparator | local application of injectable platelet-rich fibrin (i-PRF) into periodontal pockets. Receives: Biological: injectible platelet rich fibrin (i-PRF ) |
| scaling and Root Planing plus Melatonin-Loaded Injectable Platelet-Rich Fibrin | Experimental | patients will be included in this group receiving SRP with Melatonin loaded in (I-PRF) using insulin syringe for injection Receives: Drug: Melatonin-Loaded Injectable Platelet-Rich Fibrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical attachment level (CAL)
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 posted5 Jan 2026
- Study start1 Nov 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontitis Stage IIStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nora Abdelgawad Mohamed, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07316582
- Sponsor's protocol ID
- P-ME-25-16
- Status last verified
- Dec 2025
- First submitted
- 19 Dec 2025
- Last updated
- 5 Jan 2026
- 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 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Biochemical Evaluation of Melatonin Loaded in Injectable Platelet-Rich Fibrin in the Management of Stage II Grade A Periodontitis: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07316582
- Acronym / sponsor ID
- P-ME-25-16
- Conditions
- Periodontitis Stage II
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 5 Jan 2026 (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.
melatonin loaded in injectible platelet rich fibrin in treatment of periodontitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Scaling and Root Planning only | No intervention | –Mechanical removal of supra- and subgingival plaque and calculus using ultrasonic and hand instruments. |
| Injectable Platelet-Rich Fibrin (i-PRF) | Placebo comparator | Biological: injectible platelet rich fibrin (i-PRF )local application of injectable platelet-rich fibrin (i-PRF) into periodontal pockets. |
| scaling and Root Planing plus Melatonin-Loaded Injectable Platelet-Rich Fibrin | Experimental | Drug: Melatonin-Loaded Injectable Platelet-Rich Fibrinpatients will be included in this group receiving SRP with Melatonin loaded in (I-PRF) using insulin syringe for injection |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Diagnosed with stage II periodontitis based on AAP/EFP 2018 classification
- Minimum of two non-adjacent periodontal pockets <5 mm in different quadrants
- Systemically healthy individuals willing to participate and comply with follow-up visits
- Radiographic bone loss (ranged from is 10-20% mostly horizontal
Key exclusion criteria (6 listed)
- History of systemic diseases affecting periodontium (e.g., diabetes, osteoporosis)
- Use of antibiotics, anti-inflammatories, or antioxidant supplements in the past 3 months
- Smoking or tobacco use
- Pregnancy or lactation
- Allergy to melatonin or related compounds
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 |
|---|---|---|
| Melatonin-Loaded Injectable Platelet-Rich Fibrinpatients will be included in this group receiving SRP with Melatonin loaded in (I-PRF) using insulin syringe for injection | Drug | scaling and Root Planing plus Melatonin-Loaded Injectable Platelet-Rich Fibrin |
| injectible platelet rich fibrin (i-PRF )patients will be included in this group receiving (SRP) with local application of i-PRF | Biological | Injectable Platelet-Rich Fibrin (i-PRF) |
Primary outcome
Clinical attachment level (CAL)
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
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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.
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 Melatonin-Loaded Injectable Platelet-Rich Fibrin and injectible platelet rich fibrin (i-PRF ) in people with Periodontitis Stage II, run by Al-Azhar 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 6 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: enrolling by invitation, as of the sponsor's last update on 5 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
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 attachment level (CAL) (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 5 Jan 2026.