NCT07375004

Brief Summary

This study aims to evaluate the clinical and microbiological effects of using injectable Platelet-Rich Fibrin (i-PRF) as an adjunct to non-surgical periodontal therapy (scaling and root planing) in patients with periodontitis. The study uses a split-mouth design where one side of the mouth receives the treatment with i-PRF and the other side receives standard treatment alone. Clinical parameters and bacterial counts will be compared at baseline, 1 month, and 3 months after intervention .

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

November 6, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 29, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2026

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2026

Completed
Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

January 21, 2026

Last Update Submit

January 28, 2026

Conditions

Periodontal PocketAlveolar Bone LossPeriodontitis

Keywords

Injectable Platelet-Rich Fibrini-PRFScaling and Root PlaningNon-Surgical Periodontal TherapySplit-mouth designMicrobiological outcomesPeriodontitisRegeneration

Outcome Measures

Primary Outcomes (1)

  • Change in Probing Pocket Depth (PPD)

    Probing pocket depth will be measured in millimeters from the gingival margin to the base of the periodontal pocket using a standardized periodontal probe (e.g., William's probe) at six sites per tooth.

    Baseline, 1 month, and 3 months post-intervention

Secondary Outcomes (4)

  • Clinical Attachment Level (CAL)

    Baseline, 1 month, and 3 months post-intervention

  • Bleeding on Probing (BOP)

    Baseline, 1 month, and 3 months post intervention

  • Plaque Index (PI)

    Baseline, 1 month, and 3 months post intervention .

  • Microbiological Analysis (Bacterial Load)

    Baseline, 1 month, and 3 months post intervention

Study Arms (2)

Experimental: i-PRF + SRP

EXPERIMENTAL

This quadrant of the mouth will receive full-mouth scaling and root planing (SRP) followed by the subgingival injection of injectable Platelet-Rich Fibrin (i-PRF) into the periodontal pockets

Biological: Injectable Platelet-Rich Fibrin (i-PRF).Procedure: Scaling and Root Planing (SRP).

Active Comparator: SRP Alone

ACTIVE COMPARATOR

This contralateral quadrant of the mouth will receive full-mouth scaling and root planing (SRP) only, serving as the control side to compare with the i-PRF intervention.

Procedure: Scaling and Root Planing (SRP).

Interventions

Injectable Platelet-Rich Fibrin (i-PRF).BIOLOGICAL

Ten ml of whole blood is collected from the participant into plain tubes and immediately centrifuged. The centrifugation protocol follows the low-speed concept (e.g., 700 rpm for 3 minutes). The upper orange-colored liquid (i-PRF) is then collected and injected subgingivally into the periodontal pockets using a 25-gauge needle immediately after scaling and root planing

Also known as: Autologous Platelet Concentrate., i-PRF
Experimental: i-PRF + SRP
Scaling and Root Planing (SRP).PROCEDURE

Full-mouth non-surgical periodontal therapy including supra and sub-gingival scaling and root planing performed using ultrasonic devices and Gracey curettes to remove dental biofilm and calculus

Also known as: Non surgical periodontal therapy, SRP, Initial periodontal therapy, Phase I periodontal therapy, Cause related periodontal therapy
Active Comparator: SRP AloneExperimental: i-PRF + SRP

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult subjects aged 30 years and above.
  • No history of systemic diseases (e.g., diabetes mellitus).
  • Not currently under active periodontal therapy or joining other trial in the last 3 months.
  • Diagnosis with Stage II or III Periodontitis.
  • presence of interdental CAL affecting ≥2 non adjacent teeth or if CAL at buccal/lingual aspects associated with PPD \>4mm at ≥2 teeth.

You may not qualify if:

  • Smokers or alcohol users.
  • Patients consuming antibiotics or anticoagulants.
  • Regular users of non-steroidal anti-inflammatory drugs.
  • Receipt of periodontal treatment within 3 months prior to the study.
  • Any bleeding or clotting disorders.
  • Teeth with Grade II or Grade III furcation involvement.
  • Pregnant or breastfeeding mothers.
  • Patients unwilling to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mustansiriyah University, College of Dentistry.

Baghdad, Iraq

Location

MeSH Terms

Conditions

PeriodontitisPeriodontal PocketAlveolar Bone Loss

Interventions

proliferation regulatory factors, human urineTooth ExfoliationRoot Planing

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesBone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal Atrophy

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
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The study follows a double-blind protocol regarding outcome assessment and data analysis. The clinical and microbiological examiner (Outcomes Assessor) is masked to the treatment allocation. Furthermore, the statistician (Statistical Investigator) will receive the data in a coded format (e.g., Side A and Side B) without knowing which side received the i-PRF intervention until the final analysis is completed
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: This is a split-mouth randomized controlled trial. Each participant receives both treatments in different quadrants of the mouth. One quadrant is randomly assigned to the intervention (Scaling and Root Planing + i-PRF) and the contralateral quadrant serves as the control (Scaling and Root Planing alone)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master student

Study Record Dates

First Submitted

January 21, 2026

First Posted

January 29, 2026

Study Start

November 6, 2025

Primary Completion

April 28, 2026

Study Completion

May 6, 2026

Last Updated

January 30, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

IR(1)