NCT07395726

Brief Summary

The purpose of this research is to assess the efficacy of Platelet-Rich Fibrin (PRF) in the regeneration of periodontal tissues in patients suffering from periodontal disease. Periodontal disease is a chronic inflammatory disease that affects the gums and the bone supporting the teeth, which can eventually result in the loss of teeth if left untreated. Conventional periodontal treatment can control the infection and halt the progression of the disease but cannot reverse the loss of the supporting structures. Platelet-Rich Fibrin is a biologic material derived from a small amount of the patient's own blood. It has growth factors that can potentially enhance healing and facilitate the regeneration of bone and soft tissues. In this randomized controlled clinical trial, patients will be randomly assigned to either conventional periodontal surgical treatment or conventional treatment along with PRF. Over a predetermined follow-up period, clinical measurements like gum pocket depth, attachment levels, and radiographic bone changes will be assessed to see if PRF offers any extra advantages in tissue healing and regeneration. The results of this study could improve long-term oral health outcomes and periodontal disease treatment approaches.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 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

May 20, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2025

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 9, 2026

Completed
Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

5 months

First QC Date

February 1, 2026

Last Update Submit

February 1, 2026

Conditions

Keywords

Platelet-Rich FibrinPeriodontitisPeriodontal RegenerationProbing Pocket DepthClinical Attachment Level

Outcome Measures

Primary Outcomes (1)

  • Change in Probing Pocket Depth (PPD)

    Probing pocket depth will be measured in millimeters using a calibrated periodontal probe at the selected defect sites. The outcome will be defined as the mean reduction in PPD from baseline to 6 months following surgery.

    Baseline to 6 months postoperatively.

Secondary Outcomes (2)

  • Change in Clinical Attachment Level (CAL)

    Baseline to 6 months postoperatively.

  • Percentage of Radiographic Bone Fill

    Baseline to 6 months postoperatively.

Study Arms (2)

Open Flap Debridement

PLACEBO COMPARATOR

Participants assigned to this arm will undergo conventional open flap debridement (OFD) for the treatment of periodontal intrabony defects. The procedure involves flap elevation, thorough debridement of granulation tissue, root surface instrumentation, defect decontamination, and flap repositioning with suturing. Standard postoperative care and oral hygiene instructions will be provided.

Procedure: Open Flap Debridement

Platelet-Rich Fibrin with Open Flap Debridement

EXPERIMENTAL

Participants assigned to this arm will receive autologous Platelet-Rich Fibrin (PRF) as an adjunct to conventional open flap debridement. PRF will be prepared from the participant's venous blood using centrifugation and placed directly into the periodontal defect prior to flap closure to promote tissue regeneration and enhance healing. All other surgical and postoperative procedures will be identical to the control group.

Procedure: Platelet-Rich Fibrin with Open Flap Debridement

Interventions

Participants assigned to this arm will undergo conventional open flap debridement (OFD) for the treatment of periodontal intrabony defects. The procedure involves flap elevation, thorough debridement of granulation tissue, root surface instrumentation, defect decontamination, and flap repositioning with suturing. Standard postoperative care and oral hygiene instructions will be provided.

Open Flap Debridement

Participants assigned to this arm will receive autologous Platelet-Rich Fibrin (PRF) as an adjunct to conventional open flap debridement. PRF will be prepared from the participant's venous blood using centrifugation and placed directly into the periodontal defect prior to flap closure to promote tissue regeneration and enhance healing. All other surgical and postoperative procedures will be identical to the control group.

Platelet-Rich Fibrin with Open Flap Debridement

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adults aged 18-65 years. Diagnosed with chronic periodontitis according to standard clinical criteria. Presence of periodontal intrabony defects suitable for surgical intervention. Probing pocket depth (PPD) ≥ 5 mm at the target site. Clinical attachment level (CAL) loss ≥ 3 mm at the target site. Good oral hygiene, with full-mouth plaque score \< 25%.

You may not qualify if:

  • Patients with systemic diseases that affect healing (e.g., uncontrolled diabetes, immunodeficiency).
  • Pregnant or lactating women. Current smokers or tobacco users. History of periodontal surgery at the target site within the last 12 months. Use of medications that interfere with wound healing (e.g., corticosteroids, bisphosphonates).
  • Allergies or contraindications to local anesthetics or components used in the study.
  • Active oral infections or untreated caries at or near the target site.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Armed Forces Institute of Dentistry

Rawalpindi, 46000, Pakistan

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

February 1, 2026

First Posted

February 9, 2026

Study Start

May 20, 2025

Primary Completion

October 25, 2025

Study Completion

November 15, 2025

Last Updated

February 9, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Many single-center clinical trials, especially in dentistry, do not share IPD publicly. Sharing IPD requires additional ethical approval, consent language, and data management plans.

Locations