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Gingival RecessionNCT04261634

CGF and PRF in the Gingival Recessions Treatment

A study testing Concentrated Growth Factor Membrane and Platelet Rich Fibrin in people with Gingival Recession, run by Bulent Ecevit University.

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

This study hypothesized that CGFs' placement together with CAF may enhance the healing of soft tissues better than use of PRF together with CAF. Therefore, the aim of this study was to determine the clinical effects of CGF in combination with CAF compared to the clinical effect of PRF in combination with CAF in the… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Gingival Recession
What is being tested?
Concentrated Growth Factor Membrane and Platelet Rich Fibrin
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
No sites listed yet
Study dates
May 2015to May 2017
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • systemically and periodontally healthy,
  • non-smokers
  • presence of ≥ 2 buccal adjacent Miller Class I and II gingival recession with ≥ 2 mm gingival recession depth , probing depth <3 mm and gingival thickness (GT) ≥ 1 mm on both sides of the maxillary arch
  • width of keratinized gingiva ≥ 2mm
  • presence of identifiable cemento-enamel junction
  • full-mouth plaque index (PI) < 20 % and gingival index (GI) scores <1,
  • presence of tooth vitality and absence of caries, restorations and furcation involvement in the treated area,

Who cannot join

  • patients who had systemic problems that wound contraindicate for periodontal surgery, - usage of medications known to interfere with healing and to cause gingival enlargement - recession defects associated with demineralization, deep abrasion,
  • previous surgery in the defects area within the past 1 year,
  • pregnant or lactating females
  • drug and alcohol abuse

About this study

Official title: Comparison of Clinical Effects of Concentrated Growth Factor and Platelet-Rich Fibrin in the Treatment of Adjacent Multiple Gingival Recessions: A Split-Mouth Randomized Clinical Trial

This study hypothesized that CGFs' placement together with CAF may enhance the healing of soft tissues better than use of PRF together with CAF. Therefore, the aim of this study was to determine the clinical effects of CGF in combination with CAF compared to the clinical effect of PRF in combination with CAF in the treatment of adjacent multiple GRs.

Read the detailed description

The gingival margin, which should be in the cemento-enamel junction (CEJ), migrates to the apical with the effect of many facilitating and triggering etiological factors. As a result of gingival recessions (GRs), the root surface (RS) is exposed, root hypersensitivity, root caries and cervical abrasion may occur, plaque control become difficult, resulting in a non-aesthetic appearance. Platelet concentrates (PCs) increase wound healing and repair by mediating the release of growth factors (GFs), such as platelet-derived GF, fibroblast GF, transforming GF-beta and insulin-like GF-I. These GFs were released from the local application of PCs which may enable better tissue regeneration and repair in dental and medical area.

Platelet-Rich Fibrin (PRF) has a more elastic and more sturdy membrane structure, which is rich in platelets and leucocytes.Concentrated growth factor (CGF) is an another generation of PCs. It is produced by the centrifugation of venous blood and platelets are concentrated in a gel layer containing fibrin matrix as same as PRF. This study hypothesized that CGFs' placement together with (coronally advanced flap) CAF may enhance the healing of soft tissues better than use of PRF together with CAF. Therefore, the aim of this study was to determine the clinical effects of CGF in combination with CAF compared to the clinical effect of PRF in combination with CAF in the treatment of adjacent multiple GRs.

The patients of this randomized, split-mouth and controlled clinical trial study protocol were selected from individuals referred to the Department of Periodontology, at the Faculty of Dentistry, Bulent Ecevit University, for either dentin hypersensitivity or aesthetic complaints between May 2015 and June 2016.

The subjects were enrolled to this study based on the following inclusion criteria: (1) age > 18 years, (2) systemically and periodontally healthy, (3) non-smokers, (4) presence of ≥2 buccal adjacent Miller Class I or II GR with ≥2 mm GR depth (RD), probing depth (PD) <3 mm and gingival thickness (GT) ≥1 mm on both sides of the maxillary arch, (5) width of keratinized gingiva (KGW) ≥2 mm, (6) presence of identifiable cemento-enamel junction CEJ, (7) central, lateral canine and premolar teeth with GRs in the maxilla (8) full-mouth plaque control record (PCR) ≤20% (O'Leary et al. 1972) and gingival index (GI) scores = 0 (Loe, 1967) and presence of tooth vitality and absence of caries, restorations and furcation involvement in the treated area.

All the subjects received oral hygiene instructions and full-mouth scaling were performed 1 month before surgery. They were instructed to perform a non-traumatic brushing technique (Roll) using an ultra-soft toothbrush. In eighteen patients (mean age 39.67₊10.25 age; 8 females, 10 males), one side of the jaw received PRF+ CAF (37 defects), the opposite site received CGF + CAF (39 defects).

Application of PRF membrane to the control region: The patient's venous blood was taken into the 10-ml test tubes and placed quickly in the Electro-Mag centrifuge (M 815 P, İstanbul, Turkey) without shaking. The device was operated at 2700 rpm for 12 minutes to obtain PRF. Application of CGF membrane to the test region: The intravenous blood of the patient was taken into 10-ml glaas-coated test tubes without anticoagulant solutions and rapidly centrifuged with a CGF centrifuge machine (Medifuge, Silfradent, S. Sofia, Italy). The instrument's CGF program was selected and operated at speeds and angles ranging from 2700 to 3000 rpm. After approximately 13 minutes of rotation, CGF was obtained. CGF is characterized by 4 phases: (1) serum in the top layer, (2) the second buffy coat layer, (3) the third GF and unipotent stem cell layer (CGF), (4) the lower red blood cell layer (RBC). The CGFand PRF clot was removed from the tube and separated from the RBC by using microsurgical scissors. The CGF was squeezed in a special box that produces membranes at a constant thickness of 1 mm.All surgeries were performed by the same expert periodontist during a single surgical session Gingival recession sites were randomly determined as either test or control site by tossing a coin immediately before the surgical procedure.

Sutures were removed after 10 days and plaque control was maintained by CHX for additional 2 weeks. The patients started brush the tooth at the end of the 3rd week and they were again instructed in mechanical tooth cleaning of the treated tooth using an ultra soft toothbrush and roll technique. Oral hygiene instructions were provided at each postoperative visit.

Being tested
Concentrated Growth Factor Membrane, Platelet Rich Fibrin
Keywords
multiple gingival recession, platelet rich fibrin, concentrate growth factor
Medical subject headings
Gingival Recession

What participants receive

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

  • Concentrated Growth Factor MembraneProcedure or surgery

    Also called An agent of platelet concentrates

    Concentrated growth factor is produced by the centrifugation of venous blood and platelets are concentrated in a gel layer containing fibrin matrix

  • Platelet Rich FibrinProcedure or surgery

    Also called An agent of platelet concentrates

    Platelet Rich Fibrinis produced by the centrifugation of venous blood and platelets are concentrated in a gel layer containing fibrin matrix

Study groups in NCT04261634
Study groupRoleWhat they receive
Concentrated growth Factor MembraneExperimentalAutogenous platelet and leukocyte fibrin material was obtained from blood.
Receives: Procedure: Concentrated Growth Factor Membrane; Procedure: Platelet Rich Fibrin
Platelet Rich FibrinActive comparatorAutogenous platelet and leukocyte fibrin material was obtained from blood.
Receives: Procedure: Concentrated Growth Factor Membrane; Procedure: Platelet Rich Fibrin

What is being measured

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

  1. Complete root coverage

    Change from baseline in percentage of complete root coverage at 6th months.

    Measured: 6 months

Secondary outcomes (4)
  1. Percentage root coverage

    Change from baseline in percentage of complete root coverage at 6th months.

    Measured: 6 months

  2. Keratinized gingiva width

    The distance is from the mucogingival junction (MGJ) to the gingival margin

    Measured: 6 months

  3. Recession depth

    The distance is from the cemento-enamel junction to the gingival margin

    Measured: 6 th months

  4. Probing depth

    The distance is from the gingival margin to the bottom of the sulcus

    Measured: 6 th months

Timeline

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

  1. First posted10 Feb 2020
  2. Study startMay 2015
  3. Primary completionJun 2016
  4. Study completionMay 2017

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
Single group
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04261634
Sponsor's protocol ID
36290600/39
Status last verified
Feb 2020
First submitted
6 Feb 2020
Last updated
10 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Concentrated Growth Factor Membrane and Platelet Rich Fibrin in people with Gingival Recession, run by Bulent Ecevit University.

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 7 inclusion and 4 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 10 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

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?

Complete root coverage (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 10 Feb 2020.

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