Gingival RecessionNCT01793389
Platelet Rich Fibrin in the Treatment of Localized Gingival Recessions
A study testing Subepithelial 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 present study deals with treatment of localized gingival recessions. The hypothesis of this study is that platelet rich fibrin can be used an alternative to subepithelial connective tissue graft in the coverage of denuded roots. 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?
- Subepithelial 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
- 22 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2010to Nov 2011
- 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 or contralateral Miller Class I or II localized gingival recessions at least ≥ 2 mm located on incisors, canines or premolars on both jaws
- Identifiable CEJ
- 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
- Gingival thickness at least ≥ 0.8 mm for the recession area
- 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: Platelet Rich Fibrin in the Treatment of Localized Gingival Recessions: Split-mouth Randomized Clinical Trial
The present study deals with treatment of localized gingival recessions. The hypothesis of this study is that platelet rich fibrin can be used an alternative to subepithelial connective tissue graft in the coverage of denuded roots. If the platelet rich fibrin will prove to be similarly effective as subepithelial connective tissue graft, it will be possible to avoid a donor site and to decrease patient discomfort after operation.
Read the detailed description
The main objective of this split-mouth, randomized, controlled clinical trial was to compare the clinical efficacy of platelet rich fibrin (PRF) in combination with the coronally advanced flap (CAF) to the use of subepithelial connective tissue graft (SCTG) in combination with CAF in the treatment of localized gingival recessions.
Primary outcome variables were percentage of complete root coverage and change in gingival recession expressed as recession reduction in millimeters at follow-up visits. The secondary outcome variables included keratinized tissue and gingival thickness gain.
Sample size has been estimated in 22 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.
Periodontal parameters including plaque index (25) (PI), gingival index (26) (GI), probing depth (PD), clinical attachment level (CAL), and gingival recession parameters including recession depth (RD), recession width (RW), recession area (RA), keratinized tissue width (KTW), gingival thickness (GT) were assessed by a calibrated examiner. At baseline and 1, 3 and 6 months, RD, RW, RA, KTW were evaluated by means of both clinical and digital assessment. GI and PI were recorded at baseline and 1, 3 and 6 months, however PD, CAL, and GT were evaluated at baseline and 6 months. PD and CAL were recorded by a Williams probe accurate to the nearest 0.5 mm. GT was evaluated at baseline and 6 months using #15 endodontic reamer attached to a rubber stopper inserted perpendicularly into the gingival tissue 2 mm below the gingival margin; thickness was measured to the nearest 0.1 mm using a caliper.
Clinical images obtained at baseline and 1, 3 and 6 months after surgery from each treatment site and digitized in a computer image analysis system. Using a 4-mm length wire was used to check the reproducibility of the pictures. RD was measured from the cement-enamel junction (CEJ) to the gingival margin, RW was measured tangentially at the mid-facial CEJ, RA was calculated as the area within the contour of denuded root. KTW recorded as the distance from the mucogingival junction (MGJ) to the gingival margin. Duplicate measurements were made for RD, RW, RA and KTW. Percent root coverage and complete root coverage was calculated RA according to the following standard formulae.
Follow-up of subjects will be 6 months.
- Conditions
- Gingival Recession
- Being tested
- Subepithelial connective tissue graft, Platelet Rich Fibrin
- Keywords
- gingival recession, fibrin, connective tissue, root coverage, microsurgery, case-control studies
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subepithelial connective tissue graftProcedure or surgery
Platelet Rich FibrinProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Subepithelial connective tissue graft | Active comparator | Soft tissue harvested from palatum of the subjects. Receives: Procedure: Subepithelial 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.
Complete root coverage
Change from baseline in percentage of complete root coverage at 1, 3 and 6 months.
Measured: 1, 3 and 6 months
Gingival recession depth
Change from baseline in gingival recession will be assessed at 1, 3 and 6 months.
Measured: 1, 3 and 6 months
Secondary outcomes (2)
Keratinized tissue width
Change from baseline in keratinized tissue at 6 months.
Measured: 6 months
Gingival thickness
Change from baseline in gingival thickness at 6 months
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 posted15 Feb 2013 (estimated)
- Study startJan 2010
- Primary completionNov 2011
- Study completionNov 2011
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 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, Principal investigator, Ege University School of DentistryGül Atilla, Professor, Study director, Ege University School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01793389
- Sponsor's protocol ID
- 2010-Dis-002
- Status last verified
- Aug 2013
- First submitted
- 12 Feb 2013
- Last updated
- 15 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Rich Fibrin in the Treatment of Localized Gingival Recessions: Split-mouth Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01793389
- Acronym / sponsor ID
- 2010-Dis-002
- Conditions
- Gingival Recession
- Keywords
- gingival recession, fibrin, connective tissue, root coverage, microsurgery, case-control studies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 15 Feb 2013 (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 present study deals with treatment of localized gingival recessions. The hypothesis of this study is that platelet rich fibrin can be used an alternative to subepithelial connective tissue graft in the coverage of denuded roots. If the platelet rich fibrin will prove to be similarly effective as subepithelial connective tissue graft, it will be possible to avoid a donor site and to decrease patient discomfort after operation.
Detailed description
The main objective of this split-mouth, randomized, controlled clinical trial was to compare the clinical efficacy of platelet rich fibrin (PRF) in combination with the coronally advanced flap (CAF) to the use of subepithelial connective tissue graft (SCTG) in combination with CAF in the treatment of localized gingival recessions.
Primary outcome variables were percentage of complete root coverage and change in gingival recession expressed as recession reduction in millimeters at follow-up visits. The secondary outcome variables included keratinized tissue and gingival thickness gain.
Sample size has been estimated in 22 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.
Periodontal parameters including plaque index (25) (PI), gingival index (26) (GI), probing depth (PD), clinical attachment level (CAL), and gingival recession parameters including recession depth (RD), recession width (RW), recession area (RA), keratinized tissue width (KTW), gingival thickness (GT) were assessed by a calibrated examiner. At baseline and 1, 3 and 6 months, RD, RW, RA, KTW were evaluated by means of both clinical and digital assessment. GI and PI were recorded at baseline and 1, 3 and 6 months, however PD, CAL, and GT were evaluated at baseline and 6 months. PD and CAL were recorded by a Williams probe accurate to the nearest 0.5 mm. GT was evaluated at baseline and 6 months using #15 endodontic reamer attached to a rubber stopper inserted perpendicularly into the gingival tissue 2 mm below the gingival margin; thickness was measured to the nearest 0.1 mm using a caliper.
Clinical images obtained at baseline and 1, 3 and 6 months after surgery from each treatment site and digitized in a computer image analysis system. Using a 4-mm length wire was used to check the reproducibility of the pictures. RD was measured from the cement-enamel junction (CEJ) to the gingival margin, RW was measured tangentially at the mid-facial CEJ, RA was calculated as the area within the contour of denuded root. KTW recorded as the distance from the mucogingival junction (MGJ) to the gingival margin. Duplicate measurements were made for RD, RW, RA and KTW. Percent root coverage and complete root coverage was calculated RA according to the following standard formulae.
Follow-up of subjects will be 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subepithelial connective tissue graft | Active comparator | Procedure: Subepithelial connective tissue graftSoft 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 (7 listed)
- Similar bilateral or contralateral Miller Class I or II localized gingival recessions at least ≥ 2 mm located on incisors, canines or premolars on both jaws
- Identifiable CEJ
- 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 |
|---|---|---|
| Subepithelial connective tissue graft | Procedure or surgery | Subepithelial connective tissue graft |
| Platelet Rich Fibrin | Procedure or surgery | Platelet Rich Fibrin |
Primary outcome
Complete root coverage
Time frame: 1, 3 and 6 months
Change from baseline in percentage of complete root coverage at 1, 3 and 6 months.
Gingival recession depth
Time frame: 1, 3 and 6 months
Change from baseline in gingival recession will be assessed at 1, 3 and 6 months.
2 secondary outcomes
Keratinized tissue width
Time frame: 6 months
Gingival thickness
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 15 Aug 2013.
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i-PRF-Based Bioactive Matrix vs. Connective Tissue Graft in the Treatment of Gingival Recessions
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Palatal Wound Healing After Free Gingival Graft Harvest in Diabetic Patients: A Clinical Trial
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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 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 Subepithelial 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 7 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 15 Aug 2013. 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?
Complete root coverage (time frame: 1, 3 and 6 months). 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?
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 15 Aug 2013.