Intrabony Periodontal DefectNCT03433066

Advanced Platelet Rich Fibrin in Periodontal Angular Defects

A study testing Advanced platelet-rich fibrin mixed with biphasic alloplast and Biphasic alloplast mixed with saline in people with Intrabony Periodontal Defect, run by Alexandria 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 The sponsor has not verified this record for over two years, so it may be out of date.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

The aim of this study is to clinically and radiographically evaluate the efficacy of advanced platelet-rich fibrin (A-PRF) when used with biphasic alloplast in the management of intrabony defects in patients with moderate to severe chronic periodontitis. Read more about this study

Who is it for?: Ages 25 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Intrabony Periodontal Defect
What is being tested?: Advanced platelet-rich fibrin mixed with biphasic alloplast and Biphasic alloplast mixed with saline
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: 1 Mar 2018to Jun 2019
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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

They should be diagnosed as having moderate -severe chronic periodontitis according to the American Academy of Periodontology classification on gingival and periodontal diseases (1999)
Clinical attachment loss (CAL) ,radiographic evidence of the presence of at least one intrabony defect.
Patient's age between 25 to 55 years.
Both sexes.
No periodontal surgeries in the area of interest during the previous 6 months.
The presence of intrabony defects (IBD) ≥3 mm deep (distance between alveolar crest and deepest point in the defect estimated from radiographs and confirmed upon surgical exposure).
An interproximal probing depth (PD) ≥5 mm and clinical attachment loss (CAL) ≥3mm after phase I therapy in maxillary/ mandibular teeth.
The presence of an adequate zone of keratinized gingiva at the facial aspect of the selected tooth.

Who cannot join

Patients who could not maintain O'leary plaque index (54) ≤10% after phase I therapy.
Aggressive periodontitis patients.
Patients with systemic conditions known to affect the periodontal status, or, under medications known to affect the outcomes of periodontal therapy.
Pregnancy/lactation.
Smoking and tobacco use in any form.
Non vital teeth and teeth with grade III mobility.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Periodontology department, Faculty of Dentistry, Alexandria University
Alexandria, 21500

Other trials in Egypt

About this study

Official title: Evaluation of Advanced Platelet-rich Fibrin in Management of Periodontal Intrabony Defects

Read the detailed description

Biphasic alloplasts have been successfully used in management of intrabony defects. Advanced platelet-rich fibrin is believed to contain higher amount of growth factors and white blood cells than the well known PRF. Although there are some studies on the use of PRF in the treatment of intrabony defects, to date none of them evaluate the effect of the A-PRF. Therefore, a randomized controlled clinical trial was conducted to compare the healing of intrabony defects treated with A-PRF/biphasic alloplast combination and to those obtained with biphasic alloplast mixed with saline. Using a parallel arm design, 22 intrabony defects were randomly treated with either biphasic alloplast mixed with saline (control group) or with A-PRF/ biphasic alloplast combination (test group). The following clinical parameters were recorded at baseline, three and six months postoperatively : plaque index (PI), modified gingival index (MGI), probing depth (PD), clinical attachment level (CAL), while these radiographic measurements were recorded at baseline and six months postoperatively: bone fill and bone density.

Conditions: Intrabony Periodontal Defect
Being tested: Advanced platelet-rich fibrin mixed with biphasic alloplast, Biphasic alloplast mixed with saline
Keywords: advanced platelet-rich fibrin

What participants receive

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

Advanced platelet-rich fibrin mixed with biphasic alloplastProcedure or surgery
mucoperiosteal flaps will be reflected to expose the defects , which will be debrided properly and finally filled with the freshly prepared Advanced platelet-rich fibrin mixed with the biphasic alloplast.
Biphasic alloplast mixed with salineProcedure or surgery
mucoperiosteal flap will be reflected to expose and clean the intrabony defect ,then it will be filled with biphasic alloplast mixed with saline.

Study groups in NCT03433066
Study group	Role	What they receive
group I (Test)	Experimental	Advanced platelet-rich fibrin mixed with biphasic alloplast Receives: Procedure: Advanced platelet-rich fibrin mixed with biphasic alloplast
Group II (control)	Active comparator	Biphasic alloplast mixed with saline Receives: Procedure: Biphasic alloplast mixed with saline

What is being measured

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

Clinical attachment level change
The distance from cemento-enamel junction to the depth of the sulcus recorded by a periodontal probe at baseline , 3 and 6 months postoperatively
Measured: Baseline , 3 and 6 months posoperatively

Secondary outcomes (3)

Probing depth change:
The distance from the gingival margin to the depth of the sulcus recorded by a periodontal probe at baseline and 6 months postoperatively
Measured: Baseline , 3 and 6 months postoperatively
Radiographic bone density
Measuring the bone density before and after the procedure using CBCT
Measured: Baseline and 6 months postoperatively
Radiographic bone fill
The actual bone formation in the intrabony defect measured on a CBCT in comparison to the baseline CBCT
Measured: Baseline and 6 months postoperatively

Timeline

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

1 Mar 2018Jun 2019

First posted14 Feb 2018
Study start1 Mar 2018
Primary completionMar 2019 (estimated)
Study completionJun 2019 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)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 Alexandria 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
Model description: This clinical study will be conducted on twenty-two (22) interproximal intrabony defects in patients with moderate to severe chronic periodontitis.These patients will be divided randomly into two groups: * Group I: (test) will include eleven interproximal intrabony defects that will be treated with (Advanced platelet rich fibrin \& biphasic alloplast) * Group II: (control) will include eleven interproximal intrabony defects that will be treated with (biphasic alloplast mixed with saline.)
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 22 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03433066
Sponsor's protocol ID: platelet rich fibrin
Status last verified: Feb 2019
First submitted: 8 Feb 2018
Last updated: 5 Feb 2019
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Miron RJ, Fujioka-Kobayashi M, Bishara M, Zhang Y, Hernandez M, Choukroun J. Platelet-Rich Fibrin and Soft Tissue Wound Healing: A Systematic Review. Tissue Eng Part B Rev. 2017 Feb;23(1):83-99. doi: 10.1089/ten.TEB.2016.0233. Epub 2016 Oct 10.
PubMed 27672729
Mazor Z, Horowitz RA, Del Corso M, Prasad HS, Rohrer MD, Dohan Ehrenfest DM. Sinus floor augmentation with simultaneous implant placement using Choukroun's platelet-rich fibrin as the sole grafting material: a radiologic and histologic study at 6 months. J Periodontol. 2009 Dec;80(12):2056-64. doi: 10.1902/jop.2009.090252.
PubMed 19961389
Choukroun J, Diss A, Simonpieri A, Girard MO, Schoeffler C, Dohan SL, Dohan AJ, Mouhyi J, Dohan DM. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part V: histologic evaluations of PRF effects on bone allograft maturation in sinus lift. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):299-303. doi: 10.1016/j.tripleo.2005.07.012.
PubMed 16504861
Perut F, Filardo G, Mariani E, Cenacchi A, Pratelli L, Devescovi V, Kon E, Marcacci M, Facchini A, Baldini N, Granchi D. Preparation method and growth factor content of platelet concentrate influence the osteogenic differentiation of bone marrow stromal cells. Cytotherapy. 2013 Jul;15(7):830-9. doi: 10.1016/j.jcyt.2013.01.220.
PubMed 23731763
Dohan Ehrenfest DM, Del Corso M, Diss A, Mouhyi J, Charrier JB. Three-dimensional architecture and cell composition of a Choukroun's platelet-rich fibrin clot and membrane. J Periodontol. 2010 Apr;81(4):546-55. doi: 10.1902/jop.2009.090531.
PubMed 20373539
Ajwani H, Shetty S, Gopalakrishnan D, Kathariya R, Kulloli A, Dolas RS, Pradeep AR. Comparative evaluation of platelet-rich fibrin biomaterial and open flap debridement in the treatment of two and three wall intrabony defects. J Int Oral Health. 2015 Apr;7(4):32-7.
PubMed 25954068
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

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

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
Active, not recruiting
C-PRF With Minimally Invasive Non-Surgical Periodontal Therapy
Periodontitis, Intrabony Periodontal Defect
Recruiting
Flapless Periodontal Regeneration Using Hyaluronic Acid Versus Enamel Matrix Derivative
Guided Tissue Regeneration, Periodontal / Methods, Dental Enamel Proteins* / Therapeutic Use

All Intrabony Periodontal Defect trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Advanced Platelet-rich Fibrin in Management of Periodontal Intrabony Defects
ClinicalTrials.gov ID: NCT03433066
Acronym / sponsor ID: platelet rich fibrin
Conditions: Intrabony Periodontal Defect
Keywords: advanced platelet-rich fibrin
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 22 participants (estimated)
Lead sponsor: Alexandria UniversityUniversity, hospital or other
Study start: 1 Mar 2018 (actual)
Primary completion: Mar 2019 (estimated)
Study completion: Jun 2019 (estimated)
First posted: 14 Feb 2018 (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: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2
Model description: This clinical study will be conducted on twenty-two (22) interproximal intrabony defects in patients with moderate to severe chronic periodontitis.These patients will be divided randomly into two groups: * Group I: (test) will include eleven interproximal intrabony defects that will be treated with (Advanced platelet rich fibrin \& biphasic alloplast) * Group II: (control) will include eleven interproximal intrabony defects that will be treated with (biphasic alloplast mixed with saline.)

Arm	Type	Receives
group I (Test)	Experimental	Procedure: Advanced platelet-rich fibrin mixed with biphasic alloplastAdvanced platelet-rich fibrin mixed with biphasic alloplast
Group II (control)	Active comparator	Procedure: Biphasic alloplast mixed with salineBiphasic alloplast mixed with saline

Who may qualify

Ages: 25 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

They should be diagnosed as having moderate -severe chronic periodontitis according to the American Academy of Periodontology classification on gingival and periodontal diseases (1999)
Clinical attachment loss (CAL) ,radiographic evidence of the presence of at least one intrabony defect.
Patient's age between 25 to 55 years.
Both sexes.
No periodontal surgeries in the area of interest during the previous 6 months.

Key exclusion criteria (6 listed)

Patients who could not maintain O'leary plaque index (54) ≤10% after phase I therapy.
Aggressive periodontitis patients.
Patients with systemic conditions known to affect the periodontal status, or, under medications known to affect the outcomes of periodontal therapy.
Pregnancy/lactation.
Smoking and tobacco use in any form.

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 platelet-rich fibrin mixed with biphasic alloplastmucoperiosteal flaps will be reflected to expose the defects , which will be debrided properly and finally filled with the freshly prepared Advanced platelet-rich fibrin mixed with the biphasic alloplast.	Procedure or surgery	group I (Test)
Biphasic alloplast mixed with salinemucoperiosteal flap will be reflected to expose and clean the intrabony defect ,then it will be filled with biphasic alloplast mixed with saline.	Procedure or surgery	Group II (control)

Primary outcome

Clinical attachment level change
Time frame: Baseline , 3 and 6 months posoperatively
The distance from cemento-enamel junction to the depth of the sulcus recorded by a periodontal probe at baseline , 3 and 6 months postoperatively

3 secondary outcomes

Probing depth change:
Time frame: Baseline , 3 and 6 months postoperatively
Radiographic bone density
Time frame: Baseline and 6 months postoperatively
Radiographic bone fill
Time frame: Baseline and 6 months postoperatively

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
Background: PubMed 27672729Miron RJ, Fujioka-Kobayashi M, Bishara M, Zhang Y, Hernandez M, Choukroun J. Platelet-Rich Fibrin and Soft Tissue Wound Healing: A Systematic Review. Tissue Eng Part B Rev. 2017 Feb;23(1):83-99. doi: 10.1089/ten.TEB.2016.0233. Epub 2016 Oct 10.
Background: PubMed 19961389Mazor Z, Horowitz RA, Del Corso M, Prasad HS, Rohrer MD, Dohan Ehrenfest DM. Sinus floor augmentation with simultaneous implant placement using Choukroun's platelet-rich fibrin as the sole grafting material: a radiologic and histologic study at 6 months. J Periodontol. 2009 Dec;80(12):2056-64. doi: 10.1902/jop.2009.090252.
Background: PubMed 16504861Choukroun J, Diss A, Simonpieri A, Girard MO, Schoeffler C, Dohan SL, Dohan AJ, Mouhyi J, Dohan DM. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part V: histologic evaluations of PRF effects on bone allograft maturation in sinus lift. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):299-303. doi: 10.1016/j.tripleo.2005.07.012.
Background: PubMed 23731763Perut F, Filardo G, Mariani E, Cenacchi A, Pratelli L, Devescovi V, Kon E, Marcacci M, Facchini A, Baldini N, Granchi D. Preparation method and growth factor content of platelet concentrate influence the osteogenic differentiation of bone marrow stromal cells. Cytotherapy. 2013 Jul;15(7):830-9. doi: 10.1016/j.jcyt.2013.01.220.
Background: PubMed 20373539Dohan Ehrenfest DM, Del Corso M, Diss A, Mouhyi J, Charrier JB. Three-dimensional architecture and cell composition of a Choukroun's platelet-rich fibrin clot and membrane. J Periodontol. 2010 Apr;81(4):546-55. doi: 10.1902/jop.2009.090531.
Background: PubMed 25954068Ajwani H, Shetty S, Gopalakrishnan D, Kathariya R, Kulloli A, Dolas RS, Pradeep AR. Comparative evaluation of platelet-rich fibrin biomaterial and open flap debridement in the treatment of two and three wall intrabony defects. J Int Oral Health. 2015 Apr;7(4):32-7.
Background: 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.
Individual participant dataSharing planned: No

Related trials for Intrabony Periodontal Defect

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
Active, not recruiting
C-PRF With Minimally Invasive Non-Surgical Periodontal Therapy
Periodontitis, Intrabony Periodontal Defect
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.

Mohy Eldin A. ElRashidy, Professor study chair

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 8 inclusion and 6 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 5 Feb 2019. 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?

Clinical attachment level change (time frame: Baseline , 3 and 6 months posoperatively). 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 NCT03433066, which also lists 7 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 5 Feb 2019.