- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07437209
PRF + Minocycline vs Arestin in Non-surgical Perio Therapy
May 24, 2026 updated by: Nathan Estrin, Center for Advanced Rejuvenation and Esthetics
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
15
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Sarasota, Florida, United States, 34240
- Lakewood Ranch Dental
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Male and Female subjects requiring non-surgical periodontal therapy• No contraindications to periodontal treatment
Exclusion Criteria:
- 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;
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Arestin Group
Arestin placed interproximal sites after non-surgical therapy
|
Arestin evaluated as an adjunct to non-surgical therapy
|
|
Active Comparator: PRF + M Group
PRF with Minocycline placed interproximal sites after non-surgical therapy
|
PRF with Minocycline evaluated as an adjunct to non-surgical therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical Attachment Loss
Time Frame: 6 months
|
Clinical Attachment Loss was measured utilizing a periodontal probe at six sites per tooth.
|
6 months
|
|
Probing Depths
Time Frame: 6 months
|
Probing depths were recorded utilizing a periodontal probe at six sites per tooth.
|
6 months
|
|
Gingival Recession
Time Frame: 6 months
|
Gingival Recession was measured utilizing a periodontal probe at six sites per tooth.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2024
Primary Completion (Actual)
December 1, 2025
Study Completion (Actual)
December 30, 2025
Study Registration Dates
First Submitted
February 22, 2026
First Submitted That Met QC Criteria
February 22, 2026
First Posted (Actual)
February 27, 2026
Study Record Updates
Last Update Posted (Actual)
May 28, 2026
Last Update Submitted That Met QC Criteria
May 24, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- cyclopia sequence
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hypothalamic Hormones
- Peptide Hormones
- Neuropeptides
- Peptides
- Amino Acids, Peptides, and Proteins
- Nerve Tissue Proteins
- Proteins
- Organic Chemicals
- Hydrocarbons
- Hydrocarbons, Cyclic
- Polycyclic Aromatic Hydrocarbons
- Hydrocarbons, Aromatic
- Polycyclic Compounds
- Naphthacenes
- Tetracyclines
- Minocycline
- Prolactin-Releasing Hormone
Other Study ID Numbers
- 12625-NEstrin
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Data will be shared upon request
IPD Sharing Time Frame
Beginning 3 months and ending 3 years after the publication of the results
IPD Sharing Access Criteria
Data will be provided to researchers conducting a meta-analysis
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Non-surgical Periodontal Therapy
-
University of L'AquilaCompleted
-
St. Anne's University Hospital Brno, Czech RepublicKing's College LondonRecruitingPeriodontitis | Peri-implantitis | Non-surgical Periodontal TherapyCzechia
-
University of BaghdadNot yet recruiting
-
Aristotle University Of ThessalonikiUniversity of HelsinkiRecruitingPeriodontitis | Smoking, Cigarette | Non-surgical Periodontal Therapy | Dual- Light Photodynamic TherapyGreece
-
G. d'Annunzio UniversityProbiotical S.p.A.Not yet recruitingPeriodontitis | Probiotics | Non Surgical Periodontal TherapyItaly
-
University of PaviaRecruitingPeri-implantitis | Dental Implants | Non-surgical Periodontal TherapyItaly
-
Ondokuz Mayıs UniversityCompletedGingival Crevicular Fluid | Non-surgical Periodontal Therapy | Interleukin 1-beta | Sphingosine 1-phosphate | Split-mouth DesignTurkey
-
University of SienaNot yet recruitingPeriodontal Therapy | Non Responding Sites
-
University of Turin, ItalyCompletedInflammation | Periodontitis | Periodontal Diseases | Stress, Psychological | Bleeding on Probing | Non Surgical Periodontal TherapyItaly
-
October 6 UniversityRecruitingPeriodontal Intrabony Defects | Platelet-Rich Fibrin | Minimally Invasive Non-Surgical TechniqueEgypt
Clinical Trials on Arestin
-
FRAXA Research FoundationFragile X Research Foundation of CanadaCompleted
-
University of MinnesotaBausch Health Americas, Inc.CompletedBiomarkers | SRP | Minocycline HCl MicrospheresUnited States
-
OraPharmaCompletedPeri-ImplantitisUnited States
-
OraPharmaCompletedPeri-ImplantitisUnited States, Germany, Sweden, United Kingdom
-
New York State Psychiatric InstituteNational Institute of Mental Health (NIMH); Weill Medical College of Cornell...CompletedObsessive Compulsive DisorderUnited States
-
University of California, San FranciscoCompletedChronic Kidney Disease | Periodontal Disease
-
University of NebraskaCompletedModerate to Advanced Chronic PeriodontitisUnited States
-
University of South CarolinaUniversity of North Carolina, Chapel HillUnknownStroke | Periodontal Disease | TIAUnited States
-
Case Western Reserve UniversityOraPharmaRecruitingPeriodontitis, Diabetes Mellitus Type 2United States
-
University of South FloridaCompleted