Periodontitis
Conditions
Keywords
Advanced Platelet-Rich Fibrin Plus, A-PRF+, Nonsurgical Periodontal Therapy, Split-Mouth Design
Brief summary
The purpose of this randomized, controlled, split-mouth clinical trial was to determine whether adding advanced platelet-rich fibrin plus (A-PRF+), an autologous fibrin membrane prepared from the participant's own blood, to routine nonsurgical periodontal therapy could improve the healing of periodontal pockets. Adults with periodontitis and periodontal sites with a probing pocket depth of 5 mm or greater and bleeding on probing were enrolled. For each participant, one side of the mouth was randomly assigned to receive scaling and root planing plus A-PRF+ membrane placement, while the other side received scaling and root planing alone. Periodontal probing depth, clinical attachment level, gingival recession, gingival index, bleeding on probing, and plaque index were assessed at baseline and after 4 and 8 weeks.
Detailed description
This single-center study used a randomized split-mouth design, allowing each participant to serve as their own control. Each participant drew a random assignment to determine the intervention and control sides of the mouth. Both sides received routine nonsurgical periodontal therapy consisting of scaling and root planing. On the intervention side, A-PRF+ membranes prepared from autologous venous blood without anticoagulants or additives were additionally placed in eligible periodontal pockets. The control side received scaling and root planing without A-PRF+ placement. Clinical periodontal parameters were recorded at baseline, 4 weeks, and 8 weeks. The study evaluated the short-term adjunctive clinical effect of A-PRF+ on periodontal pocket healing compared with nonsurgical periodontal therapy alone.
Interventions
PROCEDUREScaling and Root Planing
Nonsurgical mechanical periodontal treatment was performed to remove supra- and subgingival plaque and calculus and to debride the root surfaces.
BIOLOGICALAdvanced Platelet-Rich Fibrin Plus
The autologous A-PRF+ membrane was prepared from venous blood collected without anticoagulants or additives and centrifuged at 1,300 rpm for 8 minutes. Following mechanical debridement and routine pocket irrigation, intervention pockets were rinsed with sterile saline before A-PRF+ membrane placement. The membrane was placed into eligible periodontal pockets and stabilized using an adhesive periodontal patch.
Sponsors
University of Medicine and Pharmacy at Ho Chi Minh City
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants were not informed which side of the mouth was assigned to the intervention or control treatment. Clinical periodontal outcomes were assessed by a calibrated examiner who was unaware of the side allocation. The clinician providing the treatment could not be masked because of the nature of the intervention.
Intervention model description
Randomized within-participant split-mouth design. Each participant received both treatments concurrently: scaling and root planing plus A-PRF+ on the randomly assigned intervention side and scaling and root planing alone on the control side.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participant-level criteria: * Adults aged 18 years or older. * Diagnosis of periodontitis according to the 2017 World Workshop criteria. * At least one eligible periodontal tooth/site in each half-mouth. * Provision of written informed consent and agreement to attend the scheduled follow-up visits. Site-level criteria: * Probing pocket depth of 5 mm or greater at baseline. * Clinical attachment loss of 3 mm or greater at baseline. * Positive bleeding on probing at baseline.
Exclusion criteria
Participant-level criteria: * Current use of tobacco or related products. * Systemic conditions closely associated with periodontitis or treatment response, including diabetes mellitus, rheumatoid arthritis, or hematologic disease. * Pregnancy or lactation. * Periodontal surgery within the preceding 6 months. * Use of medications affecting blood coagulation. * Abnormal preintervention complete blood count, prothrombin time, or activated partial thromboplastin time. * Poor oral hygiene. * Failure to attend protocol-specified visits. Tooth/site-level criteria: * Untreated dental caries or pulpal disease. * Teeth undergoing active orthodontic treatment. * Teeth with defective restorations. * Third molars. * Teeth with mobility grade II or greater. * Sites with a plaque index of 2 or greater during follow-up were excluded from the site-level analysis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Probing Pocket Depth | Baseline, 4 weeks, and 8 weeks after treatment | Probing pocket depth was measured in millimeters using a periodontal probe, from the gingival margin to the base of the periodontal pocket. Lower values indicate shallower periodontal pockets. |
| Clinical Attachment Level | Baseline, 4 weeks, and 8 weeks after treatment | Clinical attachment level was measured in millimeters using a periodontal probe, from the cementoenamel junction to the base of the periodontal pocket. Lower values indicate less clinical attachment loss. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bleeding on Probing | Baseline, 4 weeks, and 8 weeks after treatment | Description: Bleeding on probing was recorded as present or absent after periodontal probing and reported as the number and percentage of sites with a positive bleeding response. |
| Plaque Index | Baseline, 4 weeks, and 8 weeks after treatment | Plaque accumulation at each periodontal site was assessed using an ordinal plaque index scored from 0 to 3, with higher scores indicating greater plaque accumulation. |
| Gingival Recession | Baseline, 4 weeks, and 8 weeks after treatment | Gingival recession was measured in millimeters from the cementoenamel junction to the gingival margin using a periodontal probe. |
| Gingival Index | Baseline, 4 weeks, and 8 weeks after treatment | Gingival inflammation was assessed at each periodontal site using an ordinal gingival index scored from 0 to 3, with higher scores indicating greater gingival inflammation. |
Countries
Vietnam
Outcome results
None listed