Periodontal RegenerationPhase 2RCTNCT04786327

Minimally Invasive Flap With Platelet Rich Fibrin or Growth Factor Enhanced Matrix in Treatment of Intrabony Defect

A Phase 2 study testing Minimal invasive flap technique, Minimally invasive flap with root conditioning (EDTA) and platelet rich fibrin and minimally invasive flap with root contioning by EDTA and growth factor enhanced matrix GEM21S in people with Periodontal Regeneration, run by Tanta University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 30 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Periodontal Regeneration
What is being tested?: Minimal invasive flap technique, Minimally invasive flap with root conditioning (EDTA) and platelet rich fibrin and minimally invasive flap with root contioning by EDTA and growth factor enhanced matrix GEM21S
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 21 participants
Where: 1 siteEgypt
Study dates: 1 Jan 2018to 1 Oct 2019
Phase: Phase 2
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 30 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Presence of at least one tooth with PPD and CAL loss of ≥ 5 mm associated with an intra-bony defect of ≥ 2 mm according to Cortellini and Tonetti, 2007

Who cannot join

Patients with uncontrolled or poorly controlled diabetes, life-threatening conditions, or requiring antibiotic prophylaxis were excluded.
Smokers
Pregnant patients.
Patients with aggressive periodontitis.
Patients with multiple interconnected vertical defect walls.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Malak Mohamed Shoukheba
Tanta, 020

Other trials in Egypt

About this study

Official title: Intrabony Defects Management Using Growth Factor Enhanced Matrix Versus Platelet Rich Fibrin Utilizing Minimally Invasive Surgical Technique. A Randomized Clinical and Radiographic Trial.

Twenty-one intra-bony defects in fifteen systemically healthy patients with moderate to severe chronic periodontitis were randomly classified into 3 groups, 7 sites each. Group І treated by MIST alone, group ІІ treated by MIST + ethylenediamine-tetraaceticacid (EDTA) + PRF and group III treated by MIST + EDTA + GEM 21S. The clinical parameters including probing pocket depth (PPD), clinical attachment level (CAL) and bleeding on probing (BOP), were recorded at baseline, 3, 6 and 9 months post-surgery. Cone beam computed tomography (CBCT) was performed at baseline and 9 months post-surgery to evaluate bone level and bone density

Read the detailed description

: Twenty-one intra-bony defects in fifteen systemically healthy patients with moderate to severe chronic periodontitis were randomly classified into 3 groups, 7 sites each. Group І treated by MIST alone, group ІІ treated by MIST + ethylenediamine-tetraaceticacid (EDTA) + PRF and group III treated by MIST + EDTA + GEM 21S. The clinical parameters including probing pocket depth (PPD), clinical attachment level (CAL) and bleeding on probing (BOP), were recorded at baseline, 3, 6 and 9 months post-surgery. Cone beam computed tomography (CBCT) was performed at baseline and 9 months post-surgery to evaluate bone level and bone density.

Conditions: Periodontal Regeneration
Being tested: Minimal invasive flap technique, Minimally invasive flap with root conditioning (EDTA) and platelet rich fibrin, minimally invasive flap with root contioning by EDTA and growth factor enhanced matrix GEM21S
Keywords: Chronic periodontitis, Intra-bony defects, Minimally invasive surgical technique, Platelet rich fibrin,, Growth factor enhanced matrix 21S
Medical subject headings: Chronic Periodontitis

What participants receive

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

Minimal invasive flap techniqueProcedure or surgery
Also called regenerative surgery
contained defect treated with Minimally invasive flap
Minimally invasive flap with root conditioning (EDTA) and platelet rich fibrinProcedure or surgery
Also called regenerative surgery
contained defect treated by Minimally invasive flap with root conditioning (EDTA) and platelet rich fibrin graft
minimally invasive flap with root contioning by EDTA and growth factor enhanced matrix GEM21SCombination product
Also called regenerative surgery
contained defect treated with Minimally invasive flap with root conditioning (EDTA) and growth factor enhanced matrix application in the defect

Study groups in NCT04786327
Study group	Role	What they receive
treated by using Minimally invasive flap only.	Placebo comparator	7 sites treated with Minimally invasive flap only Receives: Procedure: Minimal invasive flap technique
Minimally invasive flap with root conditioning (EDTA) and platelet rich fibrin .	Experimental	7 sites treated with Minimally invasive flap plus EDTA root conditioning and application of platelet rich fibrin graft Receives: Procedure: Minimally invasive flap with root conditioning (EDTA) and platelet rich fibrin
MIST with root conditioning (EDTA) and GEM 21S .	Experimental	7 sites treated with Minimally invasive flap plus EDTA root conditioning and application of growth factor enhanced matrix GEM21S Receives: Combination Product: minimally invasive flap with root contioning by EDTA and growth factor enhanced matrix GEM21S

What is being measured

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

the change in probing pocket depth
the change in probing pocket depth was measured at baseline, 3,6 and 9 months evaluation period using periodontal probe
Measured: 9 months
the change bleeding on probing score
the change in bleeding on probing measured at baseline,3,6 and 9 months evaluation period
Measured: 9 months
the change Clinical attachment level
the change in Clinical attachment level measured at baseline, 3,6 and 9 months using the periodontal probe
Measured: 9 months
Cone beam radiograph
Cone beam radiograph for measuring the change in area of the defect, depth of the depth and bone density at baseline, 3, 6 and 9 month post operative treatment using OnDemand software of cone beam
Measured: 9 months

Timeline

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

1 Jan 20181 Oct 2019

First posted8 Mar 2021
Study start1 Jan 2018
Primary completion1 Oct 2019
Study completion1 Oct 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Periodontal RegenerationStudies of the same condition, open and under way.
More trials run by Tanta 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04786327
Sponsor's protocol ID: 4
Acronym: RCT
Status last verified: Jun 2021
First submitted: 25 Feb 2021
Last updated: 18 Jun 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

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

Active, not recruiting
L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
Not yet recruitingEarly Phase 1
The Efficacy of Exosomes Combined With Synthetic Bone Graft for the Treatment of Periodontal Intra-bony Defects
Intra-Bony Defects in Periodontitis Patients
Not yet recruitingPhase 1/2
Alveolar Ridge Preservation (ARP) Study Using Alloplastic Biomaterial and a Resorbable Synthetic Membrane. A Digital Workflow (CBCT/Scanner) Evaluates Hard and Soft Tissue Volumetric Changes at 4 Months, Validating Support for the Gingival Phenotype and Buccal Bone Plate.
Alveolar Ridge Augmentation, Bone Substitutes
Not yet recruitingObservational study
Effects of Standard PRP and Extracellular Vesicle-Enriched PRP on Human Gingival Fibroblasts
Periodontal Regeneration, Wound Healing
Recruiting
Bone Marrow Mononuclear Cells for the Repair of Severe Maxillofacial Bone Defects
Maxillofacial Bone Defect, Alveolar Bone Loss

All Periodontal Regeneration trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intrabony Defects Management Using Growth Factor Enhanced Matrix Versus Platelet Rich Fibrin Utilizing Minimally Invasive Surgical Technique. A Randomized Clinical and Radiographic Trial.
ClinicalTrials.gov ID: NCT04786327
Acronym / sponsor ID: RCT / 4
Conditions: Periodontal Regeneration
Keywords: Chronic periodontitis, Intra-bony defects, Minimally invasive surgical technique, Platelet rich fibrin,, Growth factor enhanced matrix 21S
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: Tanta UniversityUniversity, hospital or other
Study start: 1 Jan 2018 (actual)
Primary completion: 1 Oct 2019 (actual)
Study completion: 1 Oct 2019 (actual)
First posted: 8 Mar 2021 (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 (participant)
Number of arms: 3

Arm	Type	Receives
treated by using Minimally invasive flap only.	Placebo comparator	Procedure: Minimal invasive flap technique7 sites treated with Minimally invasive flap only
Minimally invasive flap with root conditioning (EDTA) and platelet rich fibrin .	Experimental	Procedure: Minimally invasive flap with root conditioning (EDTA) and platelet rich fibrin7 sites treated with Minimally invasive flap plus EDTA root conditioning and application of platelet rich fibrin graft
MIST with root conditioning (EDTA) and GEM 21S .	Experimental	Combination Product: minimally invasive flap with root contioning by EDTA and growth factor enhanced matrix GEM21S7 sites treated with Minimally invasive flap plus EDTA root conditioning and application of growth factor enhanced matrix GEM21S

Who may qualify

Ages: 30 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Presence of at least one tooth with PPD and CAL loss of ≥ 5 mm associated with an intra-bony defect of ≥ 2 mm according to Cortellini and Tonetti, 2007

Key exclusion criteria (5 listed)

Patients with uncontrolled or poorly controlled diabetes, life-threatening conditions, or requiring antibiotic prophylaxis were excluded.
Smokers
Pregnant patients.
Patients with aggressive periodontitis.
Patients with multiple interconnected vertical defect walls.

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
Minimal invasive flap techniqueAlso: regenerative surgerycontained defect treated with Minimally invasive flap	Procedure or surgery	treated by using Minimally invasive flap only.
Minimally invasive flap with root conditioning (EDTA) and platelet rich fibrinAlso: regenerative surgerycontained defect treated by Minimally invasive flap with root conditioning (EDTA) and platelet rich fibrin graft	Procedure or surgery	Minimally invasive flap with root conditioning (EDTA) and platelet rich fibrin .
minimally invasive flap with root contioning by EDTA and growth factor enhanced matrix GEM21SAlso: regenerative surgerycontained defect treated with Minimally invasive flap with root conditioning (EDTA) and growth factor enhanced matrix application in the defect	Combination product	MIST with root conditioning (EDTA) and GEM 21S .

Primary outcome

the change in probing pocket depth
Time frame: 9 months
the change in probing pocket depth was measured at baseline, 3,6 and 9 months evaluation period using periodontal probe
the change bleeding on probing score
Time frame: 9 months
the change in bleeding on probing measured at baseline,3,6 and 9 months evaluation period
the change Clinical attachment level
Time frame: 9 months
the change in Clinical attachment level measured at baseline, 3,6 and 9 months using the periodontal probe
Cone beam radiograph
Time frame: 9 months
Cone beam radiograph for measuring the change in area of the defect, depth of the depth and bone density at baseline, 3, 6 and 9 month post operative treatment using OnDemand software of cone beam

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
Individual participant dataSharing planned: No

Related trials for Periodontal Regeneration

Active, not recruiting
L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
Not yet recruitingEarly Phase 1
The Efficacy of Exosomes Combined With Synthetic Bone Graft for the Treatment of Periodontal Intra-bony Defects
Intra-Bony Defects in Periodontitis Patients
Not yet recruitingPhase 1/2
Alveolar Ridge Preservation (ARP) Study Using Alloplastic Biomaterial and a Resorbable Synthetic Membrane. A Digital Workflow (CBCT/Scanner) Evaluates Hard and Soft Tissue Volumetric Changes at 4 Months, Validating Support for the Gingival Phenotype and Buccal Bone Plate.
Alveolar Ridge Augmentation, Bone Substitutes
Not yet recruitingObservational study
Effects of Standard PRP and Extracellular Vesicle-Enriched PRP on Human Gingival Fibroblasts
Periodontal Regeneration, Wound Healing
Recruiting
Bone Marrow Mononuclear Cells for the Repair of Severe Maxillofacial Bone Defects
Maxillofacial Bone Defect, Alveolar Bone Loss

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.

malak m shoukheba, phd principal investigator

tanta university faculty of dentistry

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 1 inclusion and 5 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: finished, as of the sponsor's last update on 18 Jun 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

the change in probing pocket depth (time frame: 9 months). The study lists 4 primary outcomes in all. 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 NCT04786327.

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 18 Jun 2021.