Non-surgical Periodontal TherapyPhase 4NCT07437209
PRF + Minocycline vs Arestin in Non-surgical Perio Therapy
A Phase 4 study testing Arestin and PRF + M in people with Non-surgical Periodontal Therapy, run by Center for Advanced Rejuvenation and Esthetics at 1 site in United States.
Trial summary
Periodontitis is a chronic, biofilm-modulated inflammatory disease characterized by microbial dysbiosis and a dysregulated host immune response, eventually resulting in the gradual breakdown of the periodontal attachment apparatus. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Non-surgical Periodontal Therapy
- What is being tested?
- Arestin and PRF + M
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2024to 30 Dec 2025
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Male and Female subjects requiring non-surgical periodontal therapy• No contraindications to periodontal treatment
Who cannot join
- previous periodontal treatment within the past 6 months;
- local or systemic antibiotic treatment within the past 3 months;
- diagnosis of Stage I/ or IV periodontitis;
- poor oral hygiene defined as a full-mouth plaque score >30%;
- history of radiation or immunosuppressive therapy;
- presence of neurologic disorders, major mechanical obstruction to mouth opening, or acute temporomandibular capsulitis;
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- systemic conditions that may compromise bone metabolism or wound healing such as metabolic bone disease, uncontrolled diabetes;
- history of substance abuse such as drug or alcohol; or
- current pregnancy, nursing, or planning pregnancy during the study period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Platelet-rich Fibrin With Minocycline Versus Arestin in Non-surgical Periodontal Therapy: A Split-Mouth Randomized Controlled Clinical Trial
Periodontitis is a chronic, biofilm-modulated inflammatory disease characterized by microbial dysbiosis and a dysregulated host immune response, eventually resulting in the gradual breakdown of the periodontal attachment apparatus. While non-surgical periodontal therapy (NSPT) remains the first choice of treatment, its capability to completely resolve inflammation and pocketing in moderate disease severity may be limited, supporting the use of adjunctive antimicrobial or biologic interventions. Platelet-rich fibrin (PRF) and locally administered antibiotics, including minocycline, have individually shown clinical advantages; nonetheless, evidence assessing their combined utility remains unexplored. This split-mouth randomized controlled clinical trial (RCT) aims to compare the clinical efficacy of PRF combined with minocycline versus minocycline microspheres hydrochloride (Arestin) as adjuncts to NSPT in patients with Stage II or III, Grade A or B periodontitis.
Read the detailed description
Periodontitis is a chronic, biofilm-modulated inflammatory disease characterized by microbial dysbiosis and a dysregulated host immune response, eventually resulting in the gradual breakdown of the periodontal attachment apparatus. While non-surgical periodontal therapy (NSPT) remains the first choice of treatment, its capability to completely resolve inflammation and pocketing in moderate disease severity may be limited, supporting the use of adjunctive antimicrobial or biologic interventions. Platelet-rich fibrin (PRF) and locally administered antibiotics, including minocycline, have individually shown clinical advantages; nonetheless, evidence assessing their combined utility remains unexplored. This split-mouth randomized controlled clinical trial (RCT) aims to compare the clinical efficacy of PRF combined with minocycline versus minocycline microspheres hydrochloride (Arestin) as adjuncts to NSPT in patients with Stage II or III, Grade A or B periodontitis.
- Conditions
- Non-surgical Periodontal Therapy
- Being tested
- Arestin, PRF + M
- Keywords
- Non-surgical periodontal therapy, Platelet-rich Fibrin, Minocycline, PRF
- Medical subject headings
- cyclopia sequence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArestinDrug
Arestin evaluated as an adjunct to non-surgical therapy
PRF + MBiological
PRF with Minocycline evaluated as an adjunct to non-surgical therapy
| Study group | Role | What they receive |
|---|---|---|
| Arestin Group | Active comparator | Arestin placed interproximal sites after non-surgical therapy Receives: Drug: Arestin |
| PRF + M Group | Active comparator | PRF with Minocycline placed interproximal sites after non-surgical therapy Receives: Biological: PRF + M |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Attachment Loss
Clinical Attachment Loss was measured utilizing a periodontal probe at six sites per tooth.
Measured: 6 months
Probing Depths
Probing depths were recorded utilizing a periodontal probe at six sites per tooth.
Measured: 6 months
Gingival Recession
Gingival Recession was measured utilizing a periodontal probe at six sites per tooth.
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 posted27 Feb 2026
- Study start1 Dec 2024
- Primary completion1 Dec 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-surgical Periodontal TherapyStudies 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
- Model description
- This will be a split-mouth study in which patients undergoing non-surgical periodontal therapy will be included. One interproximal site will be assigned to receive adjunctive Arestin while another site will be randomly assigned to receive platelet-rich Fibrin mixed with minocycline.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Advanced Rejuvenation and Esthetics
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Nathan Estrin, Center for Advanced Rejuvenation and Esthetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07437209
- Sponsor's protocol ID
- 12625-NEstrin
- Status last verified
- May 2026
- First submitted
- 22 Feb 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared upon request
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet-rich Fibrin With Minocycline Versus Arestin in Non-surgical Periodontal Therapy: A Split-Mouth Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07437209
- Acronym / sponsor ID
- 12625-NEstrin
- Conditions
- Non-surgical Periodontal Therapy
- Keywords
- Non-surgical periodontal therapy, Platelet-rich Fibrin, Minocycline, PRF
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Center for Advanced Rejuvenation and EstheticsResearch network
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 27 Feb 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.
Periodontitis is a chronic, biofilm-modulated inflammatory disease characterized by microbial dysbiosis and a dysregulated host immune response, eventually resulting in the gradual breakdown of the periodontal attachment apparatus. While non-surgical periodontal therapy (NSPT) remains the first choice of treatment, its capability to completely resolve inflammation and pocketing in moderate disease severity may be limited, supporting the use of adjunctive antimicrobial or biologic interventions. Platelet-rich fibrin (PRF) and locally administered antibiotics, including minocycline, have individually shown clinical advantages; nonetheless, evidence assessing their combined utility remains unexplored. This split-mouth randomized controlled clinical trial (RCT) aims to compare the clinical efficacy of PRF combined with minocycline versus minocycline microspheres hydrochloride (Arestin) as adjuncts to NSPT in patients with Stage II or III, Grade A or B periodontitis.
Detailed description
Periodontitis is a chronic, biofilm-modulated inflammatory disease characterized by microbial dysbiosis and a dysregulated host immune response, eventually resulting in the gradual breakdown of the periodontal attachment apparatus. While non-surgical periodontal therapy (NSPT) remains the first choice of treatment, its capability to completely resolve inflammation and pocketing in moderate disease severity may be limited, supporting the use of adjunctive antimicrobial or biologic interventions. Platelet-rich fibrin (PRF) and locally administered antibiotics, including minocycline, have individually shown clinical advantages; nonetheless, evidence assessing their combined utility remains unexplored. This split-mouth randomized controlled clinical trial (RCT) aims to compare the clinical efficacy of PRF combined with minocycline versus minocycline microspheres hydrochloride (Arestin) as adjuncts to NSPT in patients with Stage II or III, Grade A or B periodontitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This will be a split-mouth study in which patients undergoing non-surgical periodontal therapy will be included. One interproximal site will be assigned to receive adjunctive Arestin while another site will be randomly assigned to receive platelet-rich Fibrin mixed with minocycline.
| Arm | Type | Receives |
|---|---|---|
| Arestin Group | Active comparator | Drug: ArestinArestin placed interproximal sites after non-surgical therapy |
| PRF + M Group | Active comparator | Biological: PRF + MPRF with Minocycline placed interproximal sites after non-surgical therapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Male and Female subjects requiring non-surgical periodontal therapy• No contraindications to periodontal treatment
Key exclusion criteria (9 listed)
- previous periodontal treatment within the past 6 months;
- local or systemic antibiotic treatment within the past 3 months;
- diagnosis of Stage I/ or IV periodontitis;
- poor oral hygiene defined as a full-mouth plaque score >30%;
- history of radiation or immunosuppressive therapy;
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 |
|---|---|---|
| ArestinArestin evaluated as an adjunct to non-surgical therapy | Drug | Arestin Group |
| PRF + MPRF with Minocycline evaluated as an adjunct to non-surgical therapy | Biological | PRF + M Group |
Primary outcome
Clinical Attachment Loss
Time frame: 6 months
Clinical Attachment Loss was measured utilizing a periodontal probe at six sites per tooth.
Probing Depths
Time frame: 6 months
Probing depths were recorded utilizing a periodontal probe at six sites per tooth.
Gingival Recession
Time frame: 6 months
Gingival Recession was measured utilizing a periodontal probe at six sites per tooth.
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 28 May 2026.
- Individual participant dataSharing planned: Yes. Data will be shared upon request
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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 Arestin and PRF + M in people with Non-surgical Periodontal Therapy, run by Center for Advanced Rejuvenation and Esthetics at 1 site in United States.
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 9 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 28 May 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 United States. 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.
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 Attachment Loss (time frame: 6 months). The study lists 3 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 28 May 2026.