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.
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.
- Conditions
- Gingival Recession
- 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 group | Role | What they receive |
|---|---|---|
| Concentrated growth Factor Membrane | Experimental | Autogenous platelet and leukocyte fibrin material was obtained from blood. Receives: Procedure: Concentrated Growth Factor Membrane; Procedure: Platelet Rich Fibrin |
| Platelet Rich Fibrin | Active comparator | Autogenous 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.
Complete root coverage
Change from baseline in percentage of complete root coverage at 6th months.
Measured: 6 months
Secondary outcomes (4)
Percentage root coverage
Change from baseline in percentage of complete root coverage at 6th months.
Measured: 6 months
Keratinized gingiva width
The distance is from the mucogingival junction (MGJ) to the gingival margin
Measured: 6 months
Recession depth
The distance is from the cemento-enamel junction to the gingival margin
Measured: 6 th months
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.
- First posted10 Feb 2020
- Study startMay 2015
- Primary completionJun 2016
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- 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
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyma Bozkurt Doğan, Ankara Yildirim Beyazıt University
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04261634
- Acronym / sponsor ID
- 36290600/39
- Conditions
- Gingival Recession
- Keywords
- multiple gingival recession, platelet rich fibrin, concentrate growth factor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 10 Feb 2020 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concentrated growth Factor Membrane | Experimental | Procedure: Concentrated Growth Factor Membrane, Procedure: Platelet Rich FibrinAutogenous platelet and leukocyte fibrin material was obtained from blood. |
| Platelet Rich Fibrin | Active comparator | Procedure: Concentrated Growth Factor Membrane, Procedure: Platelet Rich FibrinAutogenous platelet and leukocyte fibrin material was obtained from blood. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Concentrated Growth Factor MembraneAlso: An agent of platelet concentratesConcentrated growth factor is produced by the centrifugation of venous blood and platelets are concentrated in a gel layer containing fibrin matrix | Procedure or surgery | Concentrated growth Factor Membrane, Platelet Rich Fibrin |
| Platelet Rich FibrinAlso: An agent of platelet concentratesPlatelet Rich Fibrinis produced by the centrifugation of venous blood and platelets are concentrated in a gel layer containing fibrin matrix | Procedure or surgery | Concentrated growth Factor Membrane, Platelet Rich Fibrin |
Primary outcome
Complete root coverage
Time frame: 6 months
Change from baseline in percentage of complete root coverage at 6th months.
4 secondary outcomes
Percentage root coverage
Time frame: 6 months
Keratinized gingiva width
Time frame: 6 months
Recession depth
Time frame: 6 th months
Probing depth
Time frame: 6 th months
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 10 Feb 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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.