Gingival RecessionNCT02018120
Platelet Rich Fibrin in the Treatment of Multiple 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 aim of this randomized controlled clinical study is to evaluate and compare the effectiveness of platelet rich fibrin (PRF) and connective tissue grafts in the treatment of multiple gingival recessions. Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- May 2012to Aug 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Two or more adjacent teeth with at least 2 mm Miller Class I gingival recessions at non-molar teeth
- Identifiable CEJ on all teeth
- Age ≥ 18
- Presence of tooth vitality and absence of restorations and superficial caries in the treatment area
- No past surgical treatment history of affected area.
- Gingival thickness ≥ 0,8 mm for recession areas.
- Sufficient palatal donor tissue for connective tissue harvesting.
Who cannot join
- Smoking
- Pregnancy or lactation
- Systematic diseases that may affect outcomes of periodontal therapy
- Self-reported antibiotic medication within three months
- Occlusal trauma in treatment site
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University School of Dentistry Department of Periodontology
Izmir, Bornova, 35100
About this study
Official title: Comparison of Platelet Rich Fibrin and Connective Tissue Graft in Treatment of Multiple Gingival Recessions
The aim of this randomized controlled clinical study is to evaluate and compare the effectiveness of platelet rich fibrin (PRF) and connective tissue grafts in the treatment of multiple gingival recessions.
Read the detailed description
The aim of this randomized controlled clinical study is to evaluate and compare the effectiveness of platelet rich fibrin (PRF) and connective tissue grafts in the treatment of multiple gingival recessions.
Primary outcome variables were percentage of complete root coverage and mean root coverage percentages at 6 months follow up. The secondary outcome variables include keratinized tissue and gingival thickness gain.
Sample size has been estimated as 13 in each treatment arm. All recessions are treated with modified coronally advanced flap. On test sites PRF membrane and on control sites connective tissue grafts will be placed under modified coronally advanced flaps. Random allocation of the treatment sites to test and control groups were performed using a computer software designed for randomization.
Clinical parameters such as gingival index, plaque index, keratinized tissue width, gingival recession depth and width were measured at 1, 3 and 6 months. Probing pocket depth, clinical attachment level, gingival thickness and gingival recession area were measure at baseline and 6 months. All gingival recession-related parameters such as recession height, recession width and recession area and keratinized tissue width along with mean root coverage and complete root coverage were assessed on standardized clinical photographs using an image analysis software.
Clinical photographs were obtained at baseline and 1, 3 and 6 months after surgical intervention. 4 mm length wire was placed on gingiva to check reproducibility and to obtain standardized pictures.
Gingival tissue thickness were measured with an #15 endodontic reamer attached to rubber stopper inserted perpendicularly into the gingival tissue 2 mm below the gingival margin; thickness of the reamer will be measured with a digital caliper.
Mean root coverage percentage was calculated as percentage of covered root surface area at 6 months.
Follow up of subjects was 6 months.
- Conditions
- Gingival Recession
- Being tested
- connective tissue graft, platelet rich fibrin
- Keywords
- multiple gingival recession, platelet rich fibrin, connective tissue graft, microsurgery, periodontal diseases, gingival recession
- Medical subject headings
- Gingival Recession, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
connective tissue graftProcedure or surgery
platelet rich fibrinProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| connective tissue graft | Active comparator | connective tissue graft harvested from palatum of subjects and placed under modified coronally advanced flap Receives: Procedure: connective tissue graft |
| Platelet rich fibrin | Experimental | Autogenous platelet rich fibrin was obtained from subjects own blood samples after centrifugation. Platelet rich fibrin membranes were placed under modified coronally advanced flaps. Receives: Procedure: platelet rich fibrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean root coverage percentage
mean area of root coverage achieved by surgical root coverage therapy.
Measured: 6 months
complete root coverage percentage
percentage of gingival recession defects completely covered by flaps after 6 months
Measured: 6 months
Secondary outcomes (2)
keratinized tissue width
changes in keratinized tissue width at 6 months
Measured: 6 months
gingival tissue thickness
changes from baseline in gingival tissue 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 posted23 Dec 2013 (estimated)
- Study startMay 2012
- Primary completionAug 2013
- Study completionAug 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asude Merve Polat, Ege University
- Investigators
- Gül Atilla, Professor, Study director, Ege University School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02018120
- Sponsor's protocol ID
- 2012-Dis-004
- Status last verified
- Dec 2013
- First submitted
- 17 Dec 2013
- Last updated
- 23 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Platelet Rich Fibrin and Connective Tissue Graft in Treatment of Multiple Gingival Recessions
- ClinicalTrials.gov ID
- NCT02018120
- Acronym / sponsor ID
- 2012-Dis-004
- Conditions
- Gingival Recession
- Keywords
- multiple gingival recession, platelet rich fibrin, connective tissue graft, microsurgery, periodontal diseases, gingival recession
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 23 Dec 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 aim of this randomized controlled clinical study is to evaluate and compare the effectiveness of platelet rich fibrin (PRF) and connective tissue grafts in the treatment of multiple gingival recessions.
Detailed description
The aim of this randomized controlled clinical study is to evaluate and compare the effectiveness of platelet rich fibrin (PRF) and connective tissue grafts in the treatment of multiple gingival recessions.
Primary outcome variables were percentage of complete root coverage and mean root coverage percentages at 6 months follow up. The secondary outcome variables include keratinized tissue and gingival thickness gain.
Sample size has been estimated as 13 in each treatment arm. All recessions are treated with modified coronally advanced flap. On test sites PRF membrane and on control sites connective tissue grafts will be placed under modified coronally advanced flaps. Random allocation of the treatment sites to test and control groups were performed using a computer software designed for randomization.
Clinical parameters such as gingival index, plaque index, keratinized tissue width, gingival recession depth and width were measured at 1, 3 and 6 months. Probing pocket depth, clinical attachment level, gingival thickness and gingival recession area were measure at baseline and 6 months. All gingival recession-related parameters such as recession height, recession width and recession area and keratinized tissue width along with mean root coverage and complete root coverage were assessed on standardized clinical photographs using an image analysis software.
Clinical photographs were obtained at baseline and 1, 3 and 6 months after surgical intervention. 4 mm length wire was placed on gingiva to check reproducibility and to obtain standardized pictures.
Gingival tissue thickness were measured with an #15 endodontic reamer attached to rubber stopper inserted perpendicularly into the gingival tissue 2 mm below the gingival margin; thickness of the reamer will be measured with a digital caliper.
Mean root coverage percentage was calculated as percentage of covered root surface area at 6 months.
Follow up of subjects was 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| connective tissue graft | Active comparator | Procedure: connective tissue graftconnective tissue graft harvested from palatum of subjects and placed under modified coronally advanced flap |
| Platelet rich fibrin | Experimental | Procedure: platelet rich fibrinAutogenous platelet rich fibrin was obtained from subjects own blood samples after centrifugation. Platelet rich fibrin membranes were placed under modified coronally advanced flaps. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Two or more adjacent teeth with at least 2 mm Miller Class I gingival recessions at non-molar teeth
- Identifiable CEJ on all teeth
- Age ≥ 18
- Presence of tooth vitality and absence of restorations and superficial caries in the treatment area
- No past surgical treatment history of affected area.
Key exclusion criteria (5 listed)
- Smoking
- Pregnancy or lactation
- Systematic diseases that may affect outcomes of periodontal therapy
- Self-reported antibiotic medication within three months
- Occlusal trauma in treatment site
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 graft | Procedure or surgery | connective tissue graft |
| platelet rich fibrin | Procedure or surgery | Platelet rich fibrin |
Primary outcome
Mean root coverage percentage
Time frame: 6 months
mean area of root coverage achieved by surgical root coverage therapy.
complete root coverage percentage
Time frame: 6 months
percentage of gingival recession defects completely covered by flaps after 6 months
2 secondary outcomes
keratinized tissue width
Time frame: 6 months
gingival tissue 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 23 Dec 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.
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 7 inclusion and 5 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 23 Dec 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?
Mean root coverage percentage (time frame: 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 23 Dec 2013.