Intrabony Periodontal DefectNCT03922503

Clinical Effect of APRF With DFDBA Compare to Collagen Membrane With DFDBA in Intraosseous Defect

A study testing Advanced- platelets rich fibrin (A-PRF) with Demineralized freeze-dried bone allograft (DFDBA) and Collagen membrane with Demineralized freeze-dried bone allograft (DFDBA) in people with Intrabony Periodontal Defect, run by Cairo University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 25 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Intrabony Periodontal Defect
What is being tested?: Advanced- platelets rich fibrin (A-PRF) with Demineralized freeze-dried bone allograft (DFDBA) and Collagen membrane with Demineralized freeze-dried bone allograft (DFDBA)
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 1 siteEgypt
Study dates: 30 Sep 2019to 30 Dec 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 25 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Show all 10Show fewer

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Faculty of dentistry cairo university
Cairo, 12613

Other trials in Egypt

About this study

Official title: Clinical Evaluation of Advanced Platelet Rich Fibrin With (DFDBA) Compared to Collagen Membrane With (DFDBA) in Treatment of Non-contained Intraosseous Defects in Stage III Periodontitis Patients: A Randomized Clinical Trial

Read the detailed description

Treatment of intraosseous periodontal defects represents a clinical challenge; these defects have been detected through clinical and radiographic examination in 18- 51 % of patients with periodontitis. They are often associated with persistent deep pockets and bleeding following conventional periodontal treatment. Complex regenerative periodontal therapy is advocated for management of these defects. The outcomes of regenerative periodontal therapy are positively correlated with the morphology of osseous defects. Non-contained defects are prevalent clinically and have been reported to have a low regenerative potential.

Conditions: Intrabony Periodontal Defect
Being tested: Advanced- platelets rich fibrin (A-PRF) with Demineralized freeze-dried bone allograft (DFDBA), Collagen membrane with Demineralized freeze-dried bone allograft (DFDBA)
Keywords: Stage III periodontitis, APRF, Advanced Platelet Rich Fibrin, Demineralized freeze-dried bone allograft, DFDBA, Collagen Membrane, non-contained intraosseous defects, one wall intraosseous defects, combined 1- to 2-wall intraosseous defect
Medical subject headings: Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Advanced- platelets rich fibrin (A-PRF) with Demineralized freeze-dried bone allograft (DFDBA)Procedure or surgery
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.
Collagen membrane with Demineralized freeze-dried bone allograft (DFDBA)Procedure or surgery
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.

Study groups in NCT03922503
Study group	Role	What they receive
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. Receives: 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. Receives: Procedure: Collagen membrane with Demineralized freeze-dried bone allograft (DFDBA)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (4)

Pobing Depth (PD)
PD will be measured from the gingival margin to the bottom of the gingival sulcus/ periodontal pocket using UNC periodontal probe at six sites per tooth.
Measured: PD will be measured at base line, 3, 6, 9, 12 months postoperative
Gingival Recession Depth (RD)
RD will be measured from the CEJ to the most apical extension of the gingival margin using UNC periodontal probe at six sites per tooth
Measured: RD will be measured at base line, 3, 6, 9, 12 months postoperative
Radiographic defect fill (IBD)
IBD will be measured from the alveolar bone crest to the base of the defect at baseline and after 6 months to detect the amount of bone fill Individually customized bite blocks and parallel-angle technique will be used to obtain standardized radiographs. Radiographs will be scanned and the radiographic IBD depth was measured by a computer-aided software program
Measured: IBD will be measured at base line, 3, 6, 9, 12 months postoperative
Post-surgical patient satisfaction
A 3-item questionnaire will be asked to the patients and shall use a 7-point answer scale These items will be: • Would you experience the same surgery another time?
- Would you advice others with the surgery?
- To what extent are you satisfied with the results?
Measured: After 12 months postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Sep 201930 Dec 2021

First posted22 Apr 2019
Study start30 Sep 2019
Primary completion30 Oct 2021 (estimated)
Study completion30 Dec 2021 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Intrabony Periodontal DefectStudies of the same condition, open and under way.
More trials run by Cairo UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 22 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03922503
Sponsor's protocol ID: 01091495663
Status last verified: Feb 2021
First submitted: 17 Apr 2019
Last updated: 4 Feb 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 25972081
Ainamo J, Bay I. Problems and proposals for recording gingivitis and plaque. Int Dent J. 1975 Dec;25(4):229-35.
PubMed 1058834
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.
PubMed 40028653

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Treating Intrabony Defect With MINST VS MINST Extended PRF
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Treatment of Intrabony Defects With Injectable Platelet-Rich Fibrin and Xenogenic Grafts
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Alb-PRF as an Adjunct to Regenerative Periodontal Surgery
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Recruiting
Flapless Periodontal Regeneration Using Hyaluronic Acid Versus Enamel Matrix Derivative
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All Intrabony Periodontal Defect trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of Advanced Platelet Rich Fibrin With (DFDBA) Compared to Collagen Membrane With (DFDBA) in Treatment of Non-contained Intraosseous Defects in Stage III Periodontitis Patients: A Randomized Clinical Trial
ClinicalTrials.gov ID: NCT03922503
Acronym / sponsor ID: 01091495663
Conditions: Intrabony Periodontal Defect
Keywords: Stage III periodontitis, APRF, Advanced Platelet Rich Fibrin, Demineralized freeze-dried bone allograft, DFDBA, Collagen Membrane, non-contained intraosseous defects, one wall intraosseous defects
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 22 participants (estimated)
Lead sponsor: Cairo UniversityUniversity, hospital or other
Study start: 30 Sep 2019 (actual)
Primary completion: 30 Oct 2021 (estimated)
Study completion: 30 Dec 2021 (estimated)
First posted: 22 Apr 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Advanced- platelets rich fibrin with DFDBA	Experimental	Procedure: Advanced- platelets rich fibrin (A-PRF) with Demineralized freeze-dried bone allograft (DFDBA)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.
Collagen membrane and DFDBA	Active comparator	Procedure: Collagen membrane with Demineralized freeze-dried bone allograft (DFDBA)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.

Who may qualify

Ages: 25 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

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.

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Advanced- platelets rich fibrin (A-PRF) with Demineralized freeze-dried bone allograft (DFDBA)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 or surgery	Advanced- platelets rich fibrin with DFDBA
Collagen membrane with Demineralized freeze-dried bone allograft (DFDBA)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 or surgery	Collagen membrane and DFDBA

Primary outcome

Change in clinical attachment level (CAL)
Time frame: CAL will be measured at base line, 3, 6, 9, 12 months postoperative
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.

4 secondary outcomes

Pobing Depth (PD)
Time frame: PD will be measured at base line, 3, 6, 9, 12 months postoperative
Gingival Recession Depth (RD)
Time frame: RD will be measured at base line, 3, 6, 9, 12 months postoperative
Radiographic defect fill (IBD)
Time frame: IBD will be measured at base line, 3, 6, 9, 12 months postoperative
Post-surgical patient satisfaction
Time frame: After 12 months postoperative

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
Results publication: PubMed 25972081Agarwal 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.
Results publication: PubMed 1058834Ainamo J, Bay I. Problems and proposals for recording gingivitis and plaque. Int Dent J. 1975 Dec;25(4):229-35.
Derived from this study: PubMed 40028653Almoliky 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.

Related trials for Intrabony Periodontal Defect

Recruiting
A Closed Surgical Technique vs Modified Papilla Preservation Technique
Intrabony Periodontal Defect, Treatment
Recruiting
Treating Intrabony Defect With MINST VS MINST Extended PRF
Periodontal Intrabony Defects
Recruiting
Treatment of Intrabony Defects With Injectable Platelet-Rich Fibrin and Xenogenic Grafts
Periodontitis, Intrabony Periodontal Defect
Not yet recruiting
Alb-PRF as an Adjunct to Regenerative Periodontal Surgery
Periodontitis, Periodontitis Stage III
Recruiting
Flapless Periodontal Regeneration Using Hyaluronic Acid Versus Enamel Matrix Derivative
Guided Tissue Regeneration, Periodontal / Methods, Dental Enamel Proteins* / Therapeutic Use

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Manal Hosny study director

Cairo University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in clinical attachment level (CAL) (time frame: CAL will be measured at base line, 3, 6, 9, 12 months postoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03922503, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.