NCT07042204

Brief Summary

The aim of the study is to evaluate and compare the effectiveness of extended platelet-rich fibrin (ePRF) alone and in combination with bioactive glass nanoparticles in the treatment of grade II furcation defects clinically and radiographically.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2024

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

January 3, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2025

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

June 18, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 27, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2025

Completed
Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

1.4 years

First QC Date

June 18, 2025

Last Update Submit

January 12, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • The primary outcome will be the amount of bone fill vertically and horizontally obtained in the treatment of grade II furcation defects calculated from CBCT data in millimeters

    6 months follow up

Secondary Outcomes (4)

  • the secondary outcomes include improvements (decrease)of probing depth in millimetres

    3 and 6 months follow up

  • the secondary outcomes include improvements (decrease)of clinical attachment level loss in millimetres

    3 and 6 months follow up

  • the secondary outcomes include improvements (decrease) of gingival recession measured in millimetres

    3 and 6 months follow up

  • the secondary outcomes include improvements (decrease) of gingival bleeding index

    3 and 6 months follow up

Study Arms (3)

Group I

EXPERIMENTAL

10 grade II furcation defects will be treated by extended platelet-rich fibrin (ePRF) alone.

Procedure: Group I (extended platelet-rich fibrin)

Group II

EXPERIMENTAL

10 grade II furcation defects will be treated by bioactive glass nanoparticles mixed with extended platelet-rich fibrin (BGn+ePRF).

Procedure: Group II (bioactive glass nanoparticles mixed with extended platelet-rich fibrin)

Group III

ACTIVE COMPARATOR

10 grade II furcation defects will be treated by bioactive glass nanoparticles with collagen membrane.

Procedure: Group III (bioactive glass nanoparticles and covered by a collagen membrane)

Interventions

bioactive glass nanoparticles mixed with extended platelet-rich fibrin (BGn+ePRF)

Group II

bioactive glass nanoparticles and covered by a collagen membrane

Group III

mucoperiosteal flap will be raised through sulcular incisions Debridement of granulation tissue from the osseous defect and furcation will be filled with (ePRF) at the first group

Group I

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Presence of Glickman's grade II furcation defects in molars probing depth (PD) ≥5 mm horizontal PD ≥3 mm.
  • The patients are in good systemic health and had not undergone any periodontal surgery in the areas to be treated within the prior 12 months.

You may not qualify if:

  • Smokers and tobacco chewers.
  • Patients that take any medications within the past 6 months that could alter their periodontal status.
  • pregnant or lactating females.
  • Patients with known allergy to materials or drugs that will be used or prescribed in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University

Al Mansurah, 35516, Egypt

Location

MeSH Terms

Conditions

Furcation Defects

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Merna N Elnahas, Master's degree

    Mansoura Unniversity

    PRINCIPAL INVESTIGATOR

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
SPONSOR INVESTIGATOR
PI Title
BDS, Clinical demonstrator, Oral Medicine, Periodontology, Diagnosis and Oral Radiology Department

Study Record Dates

First Submitted

June 18, 2025

First Posted

June 27, 2025

Study Start

January 3, 2024

Primary Completion

June 3, 2025

Study Completion

August 3, 2025

Last Updated

January 13, 2026

Record last verified: 2026-01

Locations