NCT03922503

Brief Summary

to assess the effectiveness of advanced PRF in combination of Demineralized freeze-dried bone allograft (DFDBA) as compared to collagen membrane in combination with Demineralized freeze-dried bone allograft (DFDBA) treatment of non-contained periodontal intraosseous defects in stage III periodontitis patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 22, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

September 30, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

February 4, 2021

Status Verified

February 1, 2021

Enrollment Period

2.1 years

First QC Date

April 17, 2019

Last Update Submit

February 2, 2021

Conditions

Intrabony Periodontal Defect

Keywords

Stage III periodontitisAPRFAdvanced Platelet Rich FibrinDemineralized freeze-dried bone allograftDFDBACollagen Membranenon-contained intraosseous defectsone wall intraosseous defectscombined 1- to 2-wall intraosseous defect

Outcome Measures

Primary Outcomes (1)

  • Change in clinical attachment level (CAL)

    CAL will be measured from the CEJ to the bottom of the gingival sulcus/periodontal pocket using UNC periodontal probe at six sites per tooth.

    CAL will be measured at base line, 3, 6, 9, 12 months postoperative

Secondary Outcomes (4)

  • Pobing Depth (PD)

    PD will be measured at base line, 3, 6, 9, 12 months postoperative

  • Gingival Recession Depth (RD)

    RD will be measured at base line, 3, 6, 9, 12 months postoperative

  • Radiographic defect fill (IBD)

    IBD will be measured at base line, 3, 6, 9, 12 months postoperative

  • Post-surgical patient satisfaction

    After 12 months postoperative

Study Arms (2)

Advanced- platelets rich fibrin with DFDBA

EXPERIMENTAL

In A-PRF assigned group, one PRF will be cut into small pieces and added to the Demineralized freeze-dried bone allograft (DFDBA) in a ratio of 1:1 and the mixture is applied into the intraosseous defect, and the other will be used to prepare the membrane to cover the defect as a barrier. The mucoperiosteal flaps will be repositioned and secured in place using4-0 silk sutures.

Procedure: Advanced- platelets rich fibrin (A-PRF) with Demineralized freeze-dried bone allograft (DFDBA)

Collagen membrane and DFDBA

ACTIVE COMPARATOR

After debridement and intraoperative recordings, in the control group, Demineralized freeze-dried bone allograft (DFDBA) will be applied to the bone defect without overfilling and is protected by a collagen membrane, then interrupted sutures using 4-0 silk sutures will be placed to reposition the flaps.

Procedure: Collagen membrane with Demineralized freeze-dried bone allograft (DFDBA)

Interventions

Advanced- platelets rich fibrin (A-PRF) with Demineralized freeze-dried bone allograft (DFDBA)PROCEDURE

In A-PRF assigned group, one PRF will be cut into small pieces and added to the Demineralized freeze-dried bone allograft (DFDBA) in a ratio of 1:1 and the mixture is applied into the intraosseous defect, and the other will be used to prepare the membrane to cover the defect as a barrier.The mucoperiosteal flaps will be repositioned and secured in place using4-0 silk sutures.

Advanced- platelets rich fibrin with DFDBA
Collagen membrane with Demineralized freeze-dried bone allograft (DFDBA)PROCEDURE

After debridement and intraoperative recordings, in the control group, Demineralized freeze-dried bone allograft (DFDBA) will be applied to the bone defect without overfilling and is protected by a collagen membrane, then interrupted sutures using 4-0 silk sutures will be placed to reposition the flaps.

Collagen membrane and DFDBA

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Stage III periodontitis patient having at least one tooth with one wall or combined1- to 2-wall intraosseous defect ≥ 3 mm deep (assessed by trans-gingival probing, radiographic examination) with clinical attachment level (CAL) ≥ 5mm and pocket depth (PD) ≥ 6 mm.
  • Defect not extending to a root furcation area
  • Vital teeth
  • Non-smokers.
  • No history of intake of antibiotics or other medications affecting the periodontium in the previous 6 months.
  • No periodontal therapy carried out in the past 6 months.
  • Able to sign an informed consent form.
  • Patients age between 25 and 50 years old.
  • Patients who are cooperative, motivated, and hygiene conscious.
  • Systemically free according to Cornell Medical Index

You may not qualify if:

  • Pregnancy or breast feeding
  • The presence of an orthodontic appliance
  • Teeth mobility greater than grade I

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of dentistry cairo university

Cairo, 12613, Egypt

Location

Related Publications (3)

  • Agarwal A, Gupta ND, Jain A. Platelet rich fibrin combined with decalcified freeze-dried bone allograft for the treatment of human intrabony periodontal defects: a randomized split mouth clinical trail. Acta Odontol Scand. 2016;74(1):36-43. doi: 10.3109/00016357.2015.1035672. Epub 2015 May 14.

    PMID: 25972081RESULT

  • Ainamo J, Bay I. Problems and proposals for recording gingivitis and plaque. Int Dent J. 1975 Dec;25(4):229-35.

    PMID: 1058834RESULT

  • Almoliky N, Hosny M, Elbattawy W, Fawzy El-Sayed K. Low-Speed Platelet-Rich Fibrin Membrane in Conjunction With Demineralized Freeze-Dried Bone Allograft (DFDBA) Compared to Collagen Membrane With DFDBA in Noncontained Intraosseous Defects of Stage III Periodontitis: A Randomized Controlled Clinical Trial. Int J Dent. 2025 Feb 23;2025:6393105. doi: 10.1155/ijod/6393105. eCollection 2025.

    PMID: 40028653DERIVED

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Manal Hosny

    Cairo University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Due to the type of intervention only the outcome assessor and the statistician will be blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 17, 2019

First Posted

April 22, 2019

Study Start

September 30, 2019

Primary Completion

October 30, 2021

Study Completion

December 30, 2021

Last Updated

February 4, 2021

Record last verified: 2021-02

Locations

EG(1)