NCT07613606

Brief Summary

This study aims to clinically and radiographically evaluate the adjunctive effect of injectable platelet-rich fibrin (i-PRF) used in combination with a minimally invasive non-surgical technique for the regenerative treatment of intrabony periodontal defects.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
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 Progress39%
Mar 2026Dec 2026

Study Start

First participant enrolled

March 1, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 29, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

May 29, 2026

Status Verified

May 1, 2026

Enrollment Period

9 months

First QC Date

May 13, 2026

Last Update Submit

May 21, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Presence of comparable bilateral-walled intrabony defects

    Assessment of intrabony defect fill radiographically will be measured using the standardized paralleling technique. Presence of comparable bilateral-walled intrabony defects (PPD, \> 5 mm with intrabony defect depth ≥ 3 mm, from the alveolar crest to the defect base, at screening radiograph) not in a furcation-involved tooth.

    6 months postoperatively

Secondary Outcomes (5)

  • Clinical attachment level

    6 months postoperatively

  • Interproximal probing depth

    6 months postoperatively

  • Gingival margin

    6 months postoperatively

  • Bleeding on probing

    6 months postoperatively

  • Plaque index

    6 months postoperatively

Study Arms (2)

Group 1 (control group)

ACTIVE COMPARATOR

Patients will receive minimally invasive non-Surgical technique (MINST) alone

Procedure: Minimally invasive non-Surgical technique

Group 2 (Test group)

EXPERIMENTAL

Patients will receive minimally invasive non-Surgical technique (MINST)+ injectable platelet-rich fibrin (i-PRF) injection

Procedure: Minimally invasive non-Surgical technique + platelet-rich fibrin

Interventions

Patients will receive minimally invasive non-Surgical technique (MINST) alone

Group 1 (control group)

Patients will receive minimally invasive non-Surgical technique (MINST)+ injectable platelet-rich fibrin (i-PRF) injection

Group 2 (Test group)

Eligibility Criteria

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

You may qualify if:

  • Patients of both genders \>18 years old, medically free of systemic diseases affecting periodontal regeneration.
  • Diagnosis of 'periodontitis' stage III (grades B or C).
  • Single-rooted and multi-rooted vital teeth in either the maxilla or the mandible.
  • Presence of comparable bilateral two- or three-walled intrabony defects \[probing pocket depth (PPD), \> 5 mm with intrabony defect depth ≥ 3 mm, from the alveolar crest to the defect base, at screening radiograph\] not in a furcation-involved tooth.

You may not qualify if:

  • Patients with systemic illness known to affect the outcome of periodontal therapy, including diabetes, immune deficiencies, etc.
  • Pregnant and lactating women
  • Current use of any form of tobacco.
  • Non-surgical periodontal treatment in the past 6 months, or surgical periodontal treatment in the past 12 months.
  • Degree 2 or 3 mobility of the involved sites.6.
  • Presence of periapical pathology, acute infection, or subgingival restoration which could interfere with clinical measurements.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

October 6 University

Cairo, 12511, Egypt

RECRUITING

Central Study Contacts

Amir R Elngar, B.D.S

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
B.D.S Faculty of Dentistry, October 6 University, Egypt.

Study Record Dates

First Submitted

May 13, 2026

First Posted

May 29, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

May 29, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations