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Periodontal PocketNCT05941312

Different Autologous Products in The Treatment of Intrabony Defects

A study testing autologous products in people with Periodontal Pocket, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).

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

The aim of this study is to evaluate and compare the efficiencies of platelet-rich fibrin (PRF), concentrated growth factor (CGF) and autologous bone graft (ABG) in the treatment of patients who have intrabony pockets clinically and to assess the alveolar bone gain (AB gain) radiographically ((Panoramic X-ray and… Read more about this study

Who is it for?
Ages 30 to 53 yearsHealthy volunteers can take part
Conditions the study is for
Periodontal Pocket
What is being tested?
autologous products
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteTurkey (Türkiye)
Study dates
19 Aug 2020to 10 Jan 2022
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 30 to 53 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • no systemic disease
  • presence of two-wall intrabony defects with radiographic depth ≥3 mm
  • presence of at least four intrabony defects, one in each quadrant (in molar and premolar regions)
  • pocket depth ≥5mm
  • no periodontal treatment within past 6 months

Who cannot join

  • Smoking
  • Having a systemic disease that may affect the treatment results such as uncontrolled diabetes, metabolic bone diseases, hematological disorders, radiotherapy in the head and neck region, kidney disease,
  • Being in pregnancy or breastfeeding period,

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ahmet Cemil TALMAC

    Van, 65080

Other trials in Turkey (Türkiye)

About this study

Official title: Clinical and Radiographic Evaluation of the Use of Different Autologous Products in the Treatment of Periodontal Intrabony Defects

The aim of this study is to evaluate and compare the efficiencies of platelet-rich fibrin (PRF), concentrated growth factor (CGF) and autologous bone graft (ABG) in the treatment of patients who have intrabony pockets clinically and to assess the alveolar bone gain (AB gain) radiographically ((Panoramic X-ray and cone-beam computed tomography (CBCT) X-ray)).

Read the detailed description

Periodontitis is a complex multifactorial inflammatory disorder of periodontium, which occurs due to accumulations of microorganism that lead to gradual damage of periodontal tissues resulting in the creation of periodontal defects and recession of gingiva. This leads to the initiation of bone resorption forming bone defect known as periodontal pocket (PP). PP could be treated by surgical and non-surgical procedures. Non-surgical treatment or initial periodontal treatment (IPT) aims to remove irritant factors of periodontal disease. Surgical procedure has to be applied if inflammation persists after non-surgical procedures. One of the most common surgical procedures used for treatment of PP is an open flap debridement (OFD) which aims to remove infection and inflamed tissue, and to establish the appropriate biological situations essential for periodontal regeneration. However, the regeneration of tissues damaged by periodontitis could not be accomplished by OFD alone. Some autologous products that can be used in regenerative periodontal treatment include: ABG, autologous soft tissue graft and autologous platelet concentrates (APC).

ABGs consist of live osteoblasts, osteoprogenitor stem cells and all the three components for tissue engineering, i.e, scaffold, cells, and signaling molecules. Among the several available regeneration substances, only ABG involves osteoconductive, osteoinductive, and osteogenic properties. Due to their favorable characteristics, ABGs have been regarded as the "gold standard", and the most successful material that can be used in periodontal regeneration surgery. Despite being quite effective, ABGs have some drawbacks, including limited donor locations, insufficient bone amount, another site surgery, the possibility of some unexpected bone resorption and donor site morbidity, which includes pain, infection, sensory loss, and bleeding. Because of these shortcomings, the use of other autologous products such as autologous platelet concentrates (APC ; PRF, CGF) has become needed.

PRF is a second-generation autologous platelet concentrate as it is a natural concentrate prepared directly by taking blood from the patient without adding any anticoagulant. PRFs were firstly introduced in 2001 with the aim of simplifying the platelet-rich plasma (PRP) preparation protocol and overcoming its drawbacks. It is inexpensive, time saving, and it does not require chemical alteration in collected blood. Literature showed that the PRF membrane could stay intact and release continuously large quantities of growth factors slowly for at least 1 week, due to its fiber network scaffold. PRF shows effective outcomes in the surgical management of periodontal intra-bony and furcation defects which lead to noticeable improvement of PD and CAL. Some other dental applications are socket preservation after extraction, root covering procedure, third-molar surgery, alveolar ridge preservation, guided tissue regeneration and sinus elevation. Furthermore, PRF has the ability to enhance osseointegration of implants and can be used with grafting materials as natural resorbable membrane as an alternative to collagen membrane in managing periodontal and peri-implant defects. Nevertheless, the PRF membrane has fast biodegradability (up to 14 days). However, PRF has some limitation, as it required to be used as quickly as possible after preparation. Recently, researchers developed new products of the PRF that aim to improve the properties of PRF and obtain a better autogenous biological material by changing the centrifuge time and speed (Injectable-PRF, Advanced-PRF and CGF).

CGF is an advanced second-generation platelet concentrate, which consists of diverse growth factors that stimulate and accelerate bone formation and soft and hard tissue healing. CGF can also improve the quality of the produced new bone. CGF was firstly introduced by Sacco in 2006 as a recent improved formulation of PRF which contains high amount of growth factors and can be used successfully in regenerative treatments. It has a different preparation protocol by alternating and controlling centrifugation speeds manually or by using a special centrifuge machine, which permits the formation of a considerably larger and firmer fibrin matrix which is more abundant in growth factors compared to those observed in PRP and classic PRF. He et al26 reported that the three-dimensional fiber network scaffold of CGF could help in releasing growth factors gradually for a period between 7-10 days.

So, according to recent findings in the literature, the hypothesis of this study was that the treatment of periodontal intrabony defects by using OFD in combination with autologous products (PRF, CGF and ABG) would lead to effective outcomes compared to OFD alone. Therefore the aim of this randomized controlled clinical study was to evaluate the effects of different autologous products (PRF, CGF and ABG) on the treatment of periodontitis patients who have intrabony pockets and to compare between their efficiency clinically and radiographically.

Being tested
autologous products
Keywords
Autologous bone graft, concentrated growth factor, platelet-rich fibrin
Medical subject headings
Periodontal Pocket

What participants receive

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

  • autologous productsProcedure or surgery

    After the operation area was washed thoroughly with saline, autologous products were placed inside defects according to the related group. For the control group, the defects were left without adding any products.

Study groups in NCT05941312
Study groupRoleWhat they receive
CONTROL GROUP (GROUP 1)Active comparatorOnly open flap debridement (OFD): Conventional OFD surgery was applied to patients in all groups which began with local anesthesia (4% articaine with 1:100 000 epinephrine) after the surgical area was disinfected. Defects were thoroughly debrided firstly by using periodontal curettes and then cleaned by piezoelectric ultrasonic scaler. For the control group, the defects were left without adding any products.
Receives: Procedure: autologous products
GROUP 2Active comparatorConventional OFD surgery was applied to patients in all groups which began with local anesthesia (4% articaine with 1:100 000 epinephrine) after the surgical area was disinfected. Defects were thoroughly debrided firstly by using periodontal curettes and then cleaned by piezoelectric ultrasonic scaler. After the operation area was washed thoroughly with saline, platelet-rich fibrine (PRF) was placed inside defects
Receives: Procedure: autologous products
GROUP 3Active comparatorConventional OFD surgery was applied to patients in all groups which began with local anesthesia (4% articaine with 1:100 000 epinephrine) after the surgical area was disinfected. Defects were thoroughly debrided firstly by using periodontal curettes and then cleaned by piezoelectric ultrasonic scaler. After the operation area was washed thoroughly with saline, Consantrated Growth Factor (CGF) was placed inside defects
Receives: Procedure: autologous products
GROUP 4Active comparatorConventional OFD surgery was applied to patients in all groups which began with local anesthesia (4% articaine with 1:100 000 epinephrine) after the surgical area was disinfected. Defects were thoroughly debrided firstly by using periodontal curettes and then cleaned by piezoelectric ultrasonic scaler. After the operation area was washed thoroughly with saline, autologous bone graft (ABG) was placed inside defects
Receives: Procedure: autologous products

What is being measured

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

  1. Probing depth (PD)

    Probing depth (PD) was measured from the gingival margin to the bottom of the pocket

    Measured: Baseline (day 0) PD was evaluated. The change between baseline measurements and day 90 measurements was evaluated. Finally, the change between the baseline measurements and the 180th day measurements was evaluated.

  2. Alveolar bone height loss (ABHL)

    Alveolar bone height loss (ABHL) was measured using CBCT images from the distance between cementoenamel junction to the most apical base of the pocket.

    Measured: Baseline (day 0) ABHL was evaluated. The change between the baseline measurements and the 180th day measurements was evaluated.

Secondary outcomes (4)
  1. Plaque index (PI)

    PI was measured from the all diseased teeth. The PI score was calculated with Silness-Loe plaque index.

    0:absence of microbial plaque

    1. Thin film of microbial plaque along the free gingival margin
    2. moderate accumulation with plaque in the sulcus
    3. large amount of plaque in sulcus or pocket along the free gingival margin

    Measured: days 0, 30, 90 and 180

  2. Gingival index (GI)

    GI was measured from the all diseased teeth. The GI score was calculated with Silness-Loe plaque index.

    0:Normal gingiva

    1. Mild inflammation: slight change in color, slight oedema, no bleeding on probing
    2. Moderate inflammation: redness,oedema and glazing, bleeding on probing
    3. Severe inflammation: marked redness and oedema, ulceration, tendency to spontaneous bleeding

    Measured: days 0, 30, 90 and 180

  3. Tooth mobility (TM)

    The tooth mobility (TM) by using Periotest M device

    Measured: days 0, 30, 90 and 180

  4. Clinical attachment level (CAL)

    The clinical attachment level (CAL) was measured from the cementoenamel junction (CEJ) to the deepest point in the pocket.

    Measured: days 0, 90 and 180

Timeline

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

  1. First posted12 Jul 2023
  2. Study start19 Aug 2020
  3. Primary completion10 Jan 2022
  4. Study completion10 Jan 2022

Resources

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
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05941312
Sponsor's protocol ID
17.06.2020/19
Status last verified
Jul 2023
First submitted
14 Jun 2023
Last updated
12 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ghanaati S, Booms P, Orlowska A, Kubesch A, Lorenz J, Rutkowski J, Landes C, Sader R, Kirkpatrick C, Choukroun J. Advanced platelet-rich fibrin: a new concept for cell-based tissue engineering by means of inflammatory cells. J Oral Implantol. 2014 Dec;40(6):679-89. doi: 10.1563/aaid-joi-D-14-00138.

    PubMed 24945603
  • Alshujaa B, Talmac AC, Altindal D, Alsafadi A, Ertugrul AS. Clinical and radiographic evaluation of the use of PRF, CGF, and autogenous bone in the treatment of periodontal intrabony defects: Treatment of periodontal defect by using autologous products. J Periodontol. 2024 Aug;95(8):729-739. doi: 10.1002/JPER.23-0481. Epub 2023 Nov 20.

    PubMed 37986648

Questions about this trial

What is this clinical trial studying?

A study testing autologous products in people with Periodontal Pocket, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).

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 5 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: finished, as of the sponsor's last update on 12 Jul 2023. 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 Turkey (Türkiye). 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?

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?

Probing depth (PD) (time frame: Baseline (day 0) PD was evaluated. The change between baseline measurements and day 90 measurements was evaluated. Finally, the change between the baseline measurements and the 180th day measurements was evaluated.). The study lists 2 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 NCT05941312, which also lists 2 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 12 Jul 2023.

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