NCT07261878

Brief Summary

Evaluate of the injectable platelet rich fibrin (I-PRF) with xenograft in Intrabony defects of Periodontitis patient stage III versus Xenograft alone.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Feb 2025

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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 Progress67%
Feb 2025Dec 2026

Study Start

First participant enrolled

February 17, 2025

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 3, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2026

Expected
Last Updated

December 3, 2025

Status Verified

November 1, 2025

Enrollment Period

1 day

First QC Date

August 21, 2025

Last Update Submit

November 30, 2025

Conditions

Intrabony DefectIntrabony Defects in Chronic Periodontitis

Keywords

I-PRF with xenograft

Outcome Measures

Primary Outcomes (1)

  • Radiographic parameters

    • The bone fill after 6 months postoperatively using digital periapical radiography using parallel technique.

    6 months after treatment

Secondary Outcomes (4)

  • Pocket depth (PD)

    presurgically, 3 and 6 months interval after treatment

  • Plaque index (PI)

    pre-surgically 3 months and 6 months respectively

  • Gingival index (GI)

    pre-surgically 3 months and 6 months respectively

  • Clinical attachment level (CAL)

    pre-surgically 3 months and 6 months respectively

Study Arms (2)

injectable platelet rich fibrin and xenograft

OTHER

Intrasulcular incisions will be performed buccally and lingually/palatally on the affected tooth and extended one adjacent tooth mesially and distally, using 15c blades. Following mucoperiosteal flap elevation, thorough debridement will be performed using ultrasonic scalers and curettes until defects are clear from any granulation tissue, and the defect morphology will be visually explored and recorded .In the group 2: xenograft (Bovin xenograft) with injectable platelet Rich fibrin (I- PRF) will be applied to the intrabony defect area.

Procedure: injectable platelet rich fibrin and xenograftProcedure: Xenograft alone

xenograft alone

ACTIVE COMPARATOR

Intrasulcular incisions will be performed buccally and lingually/palatally on the affected tooth and extended one adjacent tooth mesially and distally, using 15c blades. Following mucoperiosteal flap elevation, thorough debridement will be performed using ultrasonic scalers and curettes until defects are clear from any granulation tissue, and the defect morphology will be visually explored and recorded, inserting the xenograft to the defect

Procedure: injectable platelet rich fibrin and xenograftProcedure: Xenograft alone

Interventions

injectable platelet rich fibrin and xenograftPROCEDURE

Elevation of papilla preservation flap at the site of 3mm infrabony defect ,prepearing the I-PRF which is obtained from the patients own blood , centrifuged at 700 rpm in 3 min and mixed with xenograft than placed at the defect area after removal all the granulation tissue follow up after 3 and 6 months intervals

injectable platelet rich fibrin and xenograftxenograft alone
Xenograft alonePROCEDURE

Elevation of papilla preservation flap at the site of 3mm infrabony defect after removal all the granulation tissue, the xenograft alone inserted to the defect, suturing and follow up after 3 and 6 months intervals

injectable platelet rich fibrin and xenograftxenograft alone

Eligibility Criteria

Age30 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patient should have localized Periodontitis stage III grade B with pocket depth ≥ 6mm; indicated for periodontal surgery
  • Patient's agreement to the surgical procedure and clinical trial.
  • Age ranged between 30-55 years old.
  • Intrabony defects with depth ≥3mm.
  • Free from any systemic conditions and no previous drug affect bone metabolism

You may not qualify if:

  • Smoking.
  • Pregnant women.
  • Patients in variation in anatomical landmarks.
  • Patients with psychological problems.
  • Patients with abnormal habits.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faculty of Dental Medicine for Girls, Al- Azhar University

Cairo, Cairo Governorate, Egypt

Location

Ola Jamal

Cairo, Cairo Governorate, Egypt

Location

MeSH Terms

Interventions

Transplantation, Heterologous

Intervention Hierarchy (Ancestors)

TransplantationSurgical Procedures, Operative

Study Officials

  • Eatemad Ahmed Shoreibah A Shoreibah, Professor

    Al-Azhar University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Oral Medicine, Periodontology, Oral Diagnosis and Radiology Department Faculty of Dental Medicine for Girls Al-Azhar University

Study Record Dates

First Submitted

August 21, 2025

First Posted

December 3, 2025

Study Start

February 17, 2025

Primary Completion

February 18, 2025

Study Completion (Estimated)

December 17, 2026

Last Updated

December 3, 2025

Record last verified: 2025-11

Locations

EG(2)