Gingival RecessionNCT02380872
Cytokine and MMP Levels in Gingival Crevicular Fluid in the Treatment of Localized Gingival Recessions
A study testing Connective tissue graft and Platelet Rich Fibrin in people with Gingival Recession, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
The main objective of this study was to evaluate the matrix metalloproteinase (MMP)-8, and -9, tissue inhibitor of matrix metalloproteinase and interleukin-1beta levels in gingival crevicular fluid during the early and late stages of healing for gingival recession sites treated by coronally advanced flap plus platelet… 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?
- Connective tissue graft and Platelet Rich Fibrin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2012to Oct 2013
- 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
- Similar bilateral Miller Class I or II localized gingival recessions at least ≥ 2 mm located on incisors, canines or premolars on both jaws
- Identifiable cementoenamel junction
- Age ≥ 18 years
- Presence of tooth vitality and absence of restorations and superficial caries in the area to be treated
- No periodontal surgical treatment in the previous 24 months on the involved sites
- Sufficient palatal donor tissue for the indicated SCTG.
Who cannot join
- Smoking
- Patients with a pregnancy or lactation period or self-reported history of antibiotic medication within three months
- Molar, mobile or teeth with crown or filling were also excluded.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University School of Dentistry Department of Periodontology
Izmir, 35100
About this study
Official title: Cytokine (IL-1ß) and Matrix Metalloproteinase (MMP) Levels in Gingival Crevicular Fluid After Use of Platelet Rich Fibrin or Connective Tissue Graft in the Treatment of Localized Gingival Recessions
The main objective of this study was to evaluate the matrix metalloproteinase (MMP)-8, and -9, tissue inhibitor of matrix metalloproteinase and interleukin-1beta levels in gingival crevicular fluid during the early and late stages of healing for gingival recession sites treated by coronally advanced flap plus platelet rich fibrin (PRF) compared to CAF plus connective tissue graft. As PRF consists of several growth factors, it may enhance the healing potential of soft tissues, the investigators hypothesized that using PRF in the treatment of gingival recessions might regulate inflammation and promote wound healing.
Read the detailed description
The aim of this study was to evaluate the effect of PRF by assessing gingival crevicular fluid (GCF) levels of MMP-8, MMP-9, tissue inhibitor of matrix metalloproteinase (TIMP-1) and interleukin-1beta (IL-1β) during the early and late stages of healing following coronally advanced flap (CAF) plus PRF or CAF plus connective tissue graft (CTG) treatment.
Primary outcome variables were biochemical parameters, such as: GCF MMP-8, -9, TIMP-1 and IL-1β levels. The secondary outcome variables were change in gingival recession expressed as recession reduction in millimeters at follow-up visits.
Sample size has been estimated in 24 subjects per treatment groups. Random allocation of the treatment sites to test (CAF+ PRF) and control (CAF + SCTG) groups will be performed using a computerized selection of random numbers for allocation of the study groups.
Biochemical parameters: GCF samples were obtained from each recession defect in each subject immediately prior to treatment of recessions and at 10 days, 1 month, 3 months and 6 months after surgery.
Periodontal parameters including probing depth (PD), clinical attachment level (CAL), and gingival recession parameters including recession depth (RD), recession width (RW), and keratinized tissue width (KTW),were assessed by a calibrated examiner. At baseline and at 6 months, PD, RD, RW and KTW were evaluated by clinical assessment.
Follow-up of subjects: 6 months.
- Conditions
- Gingival Recession
- Being tested
- Connective tissue graft, Platelet Rich Fibrin
- Keywords
- Gingival recession, fibrin, connective tissue, gingival crevicular fluid, matrix metalloproteinase, cytokine
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connective tissue graftProcedure or surgery
gingival recession treated with connective tissue graft
Platelet Rich FibrinProcedure or surgery
gingival recession treated with platelet rich fibrin
| Study group | Role | What they receive |
|---|---|---|
| Connective tissue graft | Active comparator | Connective tissue graft Soft tissue harvested from palatum of the subjects. Receives: Procedure: Connective tissue graft |
| Platelet Rich Fibrin | Experimental | Autogenous platelet and leukocyte fibrin material was obtained from blood. Receives: Procedure: Platelet Rich Fibrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in MMP-8 gingival crevicular fluid level at 10 days, 1, 3 and 6 months
Measured: Baseline, 10 days, 1, 3 and 6 months
Change from Baseline in MMP-9 gingival crevicular fluid level at 10 days, 1, 3 and 6 months
Measured: Baseline, 10 days, 1, 3 and 6 months
Change from Baseline in TIMP-1 gingival crevicular fluid level at 10 days, 1, 3 and 6 months
Measured: Baseline, 10 days, 1, 3 and 6 months
Change from Baseline in IL-1beta gingival crevicular fluid level at 10 days, 1, 3 and 6 months
Measured: Baseline, 10 days, 1, 3 and 6 months
Secondary outcomes (1)
Gingival recession depth
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study startOct 2012
- Primary completionSep 2013
- Study completionOct 2013
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.
- More trials run by Ege 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülnihal Eren, Research Asisstant, Ege University
- Investigators
- Gülnihal Eren, PhD. Dr., Principal investigator, Ege University School of DentistryGül Atilla, Professor, Study director, Ege University School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02380872
- Sponsor's protocol ID
- Ege Uni School of Dentistry
- Status last verified
- Mar 2015
- First submitted
- 14 Feb 2015
- Last updated
- 5 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytokine (IL-1ß) and Matrix Metalloproteinase (MMP) Levels in Gingival Crevicular Fluid After Use of Platelet Rich Fibrin or Connective Tissue Graft in the Treatment of Localized Gingival Recessions
- ClinicalTrials.gov ID
- NCT02380872
- Acronym / sponsor ID
- Ege Uni School of Dentistry
- Conditions
- Gingival Recession
- Keywords
- Gingival recession, fibrin, connective tissue, gingival crevicular fluid, matrix metalloproteinase, cytokine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 5 Mar 2015 (estimated)
- 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.
The main objective of this study was to evaluate the matrix metalloproteinase (MMP)-8, and -9, tissue inhibitor of matrix metalloproteinase and interleukin-1beta levels in gingival crevicular fluid during the early and late stages of healing for gingival recession sites treated by coronally advanced flap plus platelet rich fibrin (PRF) compared to CAF plus connective tissue graft. As PRF consists of several growth factors, it may enhance the healing potential of soft tissues, the investigators hypothesized that using PRF in the treatment of gingival recessions might regulate inflammation and promote wound healing.
Detailed description
The aim of this study was to evaluate the effect of PRF by assessing gingival crevicular fluid (GCF) levels of MMP-8, MMP-9, tissue inhibitor of matrix metalloproteinase (TIMP-1) and interleukin-1beta (IL-1β) during the early and late stages of healing following coronally advanced flap (CAF) plus PRF or CAF plus connective tissue graft (CTG) treatment.
Primary outcome variables were biochemical parameters, such as: GCF MMP-8, -9, TIMP-1 and IL-1β levels. The secondary outcome variables were change in gingival recession expressed as recession reduction in millimeters at follow-up visits.
Sample size has been estimated in 24 subjects per treatment groups. Random allocation of the treatment sites to test (CAF+ PRF) and control (CAF + SCTG) groups will be performed using a computerized selection of random numbers for allocation of the study groups.
Biochemical parameters: GCF samples were obtained from each recession defect in each subject immediately prior to treatment of recessions and at 10 days, 1 month, 3 months and 6 months after surgery.
Periodontal parameters including probing depth (PD), clinical attachment level (CAL), and gingival recession parameters including recession depth (RD), recession width (RW), and keratinized tissue width (KTW),were assessed by a calibrated examiner. At baseline and at 6 months, PD, RD, RW and KTW were evaluated by clinical assessment.
Follow-up of subjects: 6 months.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Connective tissue graft | Active comparator | Procedure: Connective tissue graftConnective tissue graft Soft tissue harvested from palatum of the subjects. |
| Platelet Rich Fibrin | Experimental | 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 (6 listed)
- Similar bilateral Miller Class I or II localized gingival recessions at least ≥ 2 mm located on incisors, canines or premolars on both jaws
- Identifiable cementoenamel junction
- Age ≥ 18 years
- Presence of tooth vitality and absence of restorations and superficial caries in the area to be treated
- No periodontal surgical treatment in the previous 24 months on the involved sites
Key exclusion criteria (3 listed)
- Smoking
- Patients with a pregnancy or lactation period or self-reported history of antibiotic medication within three months
- Molar, mobile or teeth with crown or filling were also excluded.
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 |
|---|---|---|
| Connective tissue graftgingival recession treated with connective tissue graft | Procedure or surgery | Connective tissue graft |
| Platelet Rich Fibringingival recession treated with platelet rich fibrin | Procedure or surgery | Platelet Rich Fibrin |
Primary outcome
Change from Baseline in MMP-8 gingival crevicular fluid level at 10 days, 1, 3 and 6 months
Time frame: Baseline, 10 days, 1, 3 and 6 months
Change from Baseline in MMP-9 gingival crevicular fluid level at 10 days, 1, 3 and 6 months
Time frame: Baseline, 10 days, 1, 3 and 6 months
Change from Baseline in TIMP-1 gingival crevicular fluid level at 10 days, 1, 3 and 6 months
Time frame: Baseline, 10 days, 1, 3 and 6 months
Change from Baseline in IL-1beta gingival crevicular fluid level at 10 days, 1, 3 and 6 months
Time frame: Baseline, 10 days, 1, 3 and 6 months
1 secondary outcome
Gingival recession depth
Time frame: 6 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 5 Mar 2015.
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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.
Gülnihal Eren, PhD. Dr. principal investigator
Ege University School of Dentistry
Gül Atilla, Professor study director
Ege University School of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Connective tissue graft and Platelet Rich Fibrin in people with Gingival Recession, run by Ege 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 6 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 5 Mar 2015. 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?
Change from Baseline in MMP-8 gingival crevicular fluid level at 10 days, 1, 3 and 6 months (time frame: Baseline, 10 days, 1, 3 and 6 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?
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 Mar 2015.