NCT07782736

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 3, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 24, 2026

Completed
Last Updated

August 24, 2026

Status Verified

August 1, 2026

Enrollment Period

7 months

First QC Date

August 20, 2026

Last Update Submit

August 20, 2026

Conditions

Keywords

Advanced Platelet-Rich Fibrin PlusA-PRF+Nonsurgical Periodontal TherapySplit-Mouth Design

Outcome Measures

Primary Outcomes (2)

  • Probing Pocket Depth

    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.

    Baseline, 4 weeks, and 8 weeks after treatment

  • Clinical Attachment Level

    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.

    Baseline, 4 weeks, and 8 weeks after treatment

Secondary Outcomes (4)

  • Gingival Recession

    Baseline, 4 weeks, and 8 weeks after treatment

  • Gingival Index

    Baseline, 4 weeks, and 8 weeks after treatment

  • Bleeding on Probing

    Baseline, 4 weeks, and 8 weeks after treatment

  • Plaque Index

    Baseline, 4 weeks, and 8 weeks after treatment

Study Arms (2)

Intervention Side: Scaling and Root Planing Plus A-PRF+

EXPERIMENTAL

Eligible periodontal pockets on the randomly assigned intervention side received scaling and root planing followed by placement of an autologous A-PRF+ membrane.

Procedure: Scaling and Root PlaningBiological: Advanced Platelet-Rich Fibrin Plus

Control Side: Scaling and Root Planing Alone

ACTIVE COMPARATOR

Eligible periodontal pockets on the contralateral control side received scaling and root planing without A-PRF+ membrane placement.

Procedure: Scaling and Root Planing

Interventions

Nonsurgical mechanical periodontal treatment was performed to remove supra- and subgingival plaque and calculus and to debride the root surfaces.

Control Side: Scaling and Root Planing AloneIntervention Side: Scaling and Root Planing Plus A-PRF+

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.

Intervention Side: Scaling and Root Planing Plus A-PRF+

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Specialty Dental Clinic, Faculty of Odonto-Stomatology, University of Medicine and Pharmacy at Ho Chi Minh City

Ho Chi Minh City, Vietnam

Location

MeSH Terms

Conditions

Periodontitis

Interventions

Tooth ExfoliationRoot Planing

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaDental ScalingDental ProphylaxisPeriodonticsDentistrySubgingival CurettagePreventive Dentistry

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor of Dental Surgery

Study Record Dates

First Submitted

August 20, 2026

First Posted

August 24, 2026

Study Start

October 3, 2025

Primary Completion

April 24, 2026

Study Completion

April 24, 2026

Last Updated

August 24, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared. Only aggregate study results will be reported in scientific publications.

Locations