Gingival RecessionNCT03121872
Titanium Prepared Platelet Rich Fibrin for Multiple Gingival Recessions
A study testing Root Coverage Surgery with T-PRF and Root Coverage Surgery with CTG in people with Gingival Recession, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial summary
Objective: Titanium-prepared platelet-rich fibrin (T-PRF) is activated with titanium, which results in a more mature and aggregated form than PRF. In our previous studies, we established that the fibrin carpet formed with titanium had a firmer network structure, and longer resorption time in the tissue than the fibrin… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Root Coverage Surgery with T-PRF and Root Coverage Surgery with CTG
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 May 2014to 5 Aug 2016
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Eligibility criteria included the following:
- Absence of systemic disease that would likely hinder periodontal surgery or unfavourably influence wound healing
- Having multiple gingival recessions including at least two adjacent Miller class I or II teeth among mandibular or maxillary incisors and premolars. Molars were excluded.
- The teeth undergoing treatment were vital with no restoration or decay in the tooth neck (collum dentis) and with a completely or partially fixable enamel-cement border
- The relevant teeth in the arch were rotation-free with no mobility
- The presence of periodontal pockets not exceeding 3 mm in the teeth undergoing treatment; the teeth had no occlusal trauma; and the patients were older than 18 years of age
Who cannot join
- Receiving medicines that would likely cause gingival hypertrophy
- Smokers
- Presence of blood-borne diseases
- Presence of any systemic disease likely to influence coagulation, and receiving any anticoagulant medicines
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness and Predictability of Titanium-Prepared Platelet-Rich Fibrin for the Management of Multiple Gingival Recessions
Objective: Titanium-prepared platelet-rich fibrin (T-PRF) is activated with titanium, which results in a more mature and aggregated form than PRF. In our previous studies, we established that the fibrin carpet formed with titanium had a firmer network structure, and longer resorption time in the tissue than the fibrin carpet formed with glass. The purpose of this randomized controlled clinical trial is to compare the effects of autogenous T-PRF and CTG.
Materials and methods: A total 114 Miller Class I/II gingival recessions with abrasion defects will be treated either T-PRF (63 teeth) or CTG (51 teeth) using a modified tunnel technique. Clinical periodontal indexes, keratinized tissue (KTW), gingival thickness (GT) and recession depth (RD) will be recorded before surgery and at 6 and 12-month follow-up examinations. The Visual Analog Scale and healing index scores will be assessed.
Read the detailed description
A total of 34 patients will be informed in detail about the risks and benefits of each step of the study, and their signed consents will be obtained.
These clinical assessments will be done:
- Plaque Index and Gingival Index In case of multiple gingival recessions, plaque index and gingival index will be obtained from the three dental points as mesial, distal and vestibule midpoints; plaque index will be calculated according to Sillnes\&Löe criteria, whereas gingival index will be calculated according to Löe\&Silness criteria.
- Periodontal Pocket Depth In case of multiple gingival recessions, the distance between the pocket base and free gingival margin will be measured separately for each tooth with the assistance of periodontal Williams probe through the midpoint of vestibule.
- Recession Width Periodontal probe will be horizontally placed on the enamel-cement border and the measurement will be recorded.
- Recession Depth The defect distance will be measured vertically from the enamel-cement conjunction of the tooth to the very apical aspect of the gingival margin using periodontal probe and recorded in millimeters.
- Clinical Attachment Level The clinical attachment level (CAL) will be measured by periodontal probe through the midpoint of vestibule as the distance between gingiva base and enamel-cement border and recorded in millimeters.
- Keratinized Tissue Width The distance between gingival margin and alveolar mucosa will be measured in millimeters. A solution consisted of 10% potassium iodide and 5% iodine will be applied onto the gingiva and alveolar mucosa with a cotton pellet. This solution stains the glycogen-rich alveolar mucosa darker than the keratinized tissue and allows keratinized gingival mucosa to be exposed more clearly.
- Gingival Thickness This measurement will be performed in the relevant area by No. 15 endodontic spreader under topical anesthesia. The spreader will be placed perpendicular to the gingiva through approximately 1.5 mm apical aspect of the gingival margin, pushed forward until obtaining bone support, and fixed with a disc. The distance between the disc and the tip of endochuck will be measured by a digital caliper with a sensitivity of 0.1 mm.
- Measurement of CTG Thickness Fat and glandular tissue and band-shape epithelium on the CTG, which will be derived from the maxillary palate, will be removed by a scissor. The graft, which will be placed onto a sterile, metal smooth surface, will be fixed through its mesial, distal and middle aspects by a No. 15 endodontic spreader with the assistance of a disc and then measured by digital caliper. The mean graft thickness will be calculated as the arithmetic mean of the values measured.
- Measurement of T-TRF Membrane Thickness Two thrombocyte rich platelets taken from the tubes that have been centrifuged will be separated from the serum at room temperature in sterile gauze and will be turned into membranes. They will be measured by digital caliper as two-layer similar to the measurement of connective tissue thickness, and the values will be recorded..
VAS Assessment On the postoperative Day 1, 3 and 7, the patients will be asked to complete a chart where they can rate subjective complaints of pain, burning sensation and discomfort in the surgery site between 0 (none) and 100 (very severe).
Wound Healing Index While removing the sutures two weeks after surgery, the physician will evaluate wound healing according to the Huang criteria separately for each tooth; Score 1: Problem-free wound healing without gingival edema, erythema, suppuration, or dehiscence of the flap margins.
Score 2. Problem-free wound healing with mild gingival edema, erythema, patient discomfort and flap dehiscence without suppuration.
Score 3. Poor wound healing with severe gingival edema, erythema, suppuration, patient discomfort and flap dehiscence.
Calculation of Root Surface Coverage Ratio This ratio is presented as percentage (%) and evaluated in the 6th and 12th months.
Preoperative recession depth - Postoperative recession depth X 100 % Preoperative recession depth
- Conditions
- Gingival Recession
- Being tested
- Root Coverage Surgery with T-PRF, Root Coverage Surgery with CTG
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Root Coverage Surgery with T-PRFProcedure or surgery
Root surfaces in the multiple gingival recession regions were made smooth using Gracey curettes. To remove the smear layer, 24% EDTA solution was applied to the tooth surfaces for approximately 2 minutes and then washed with physiological saline. The receiver region was prepared using the modified tunnel method. After passive stabilization of the flap in the coronal aspect, the preparation of the donor region was initiated
Root Coverage Surgery with CTGProcedure or surgery
Root surfaces in the multiple gingival recession regions were made smooth using Gracey curettes. To remove the smear layer, 24% EDTA solution was applied to the tooth surfaces for approximately 2 minutes and then washed with physiological saline. The receiver region was prepared using the modified tunnel method. After passive stabilization of the flap in the coronal aspect, the preparation of the donor region was initiated
| Study group | Role | What they receive |
|---|---|---|
| Root Coverage Surgery with T-PRF | Experimental | Multiple gingival recessions were treated by Titanium prepared PRF (T-PRF) in 16 patients.
The T-PRF membrane that was procured was placed in the defect area 1 mm beyond the enamel-cement border.. The T-PRF was fixed in the receiver area by a mattress stitch through the apical aspect using 5-0 monofilament absorbable sutures. The flap was stitched in a manner that completely covered the graft in the coronal aspect. Thereafter, the graft was fixed to the flap on the coronal aspect with horizontal mattress sutures. Compression was applied to the receiver area with serum-impregnated sterile gauze for approximately 5 minutes, and then periodontal paste was placed onto the surgery site. Receives: Procedure: Root Coverage Surgery with T-PRF |
| Root Coverage Surgery with CTG | Active comparator | Multiple gingival recessions were treated by Connective Tissue Graft (CTG)in 18 patients.The CTG width was measured to include 1 mm beyond the root surface defects in the receiver area. Following anaesthesia of the palate, the borders of the start and finish incisions were marked. Subepithelial connective tissue that was 1.5-2 mm thick and excluded the periosteum was removed and maintained in physiological saline. The palate was stitched with 4-0 absorbable sutures (Pegalak, Doğsan, Turkey) and covered with a periodontal paste.
Before placing the connective tissue in the receiver area, the fat and glandular tissues and the band-shaped epithelium on the connective tissue were removed using scissors. Receives: Procedure: Root Coverage Surgery with CTG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Root Coverage Percentage at 12 months
Preoperative recession depth - Postoperative recession depth X 100 % Preoperative recession depth
Measured: Change from baseline Root Coverage Percentage at 12 months
Secondary outcomes (1)
Keratinized Tissue Width at 12 months
The distance between gingival margin to mucogingival junction
Measured: Change from baseline Keratinized Tissue Width at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2017
- Study start21 May 2014
- Primary completion20 May 2016
- Study completion5 Aug 2016
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
- Parallel groups
- Model description
- In this randomized controlled clinical trial, multiple gingival recessions were treated by T-PRF in 16 patients and by CTG in 18 patients selected by the coin-toss method. All surgical procedures, measurements and follow-up were performed by the same clinician
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Ercan, Karadeniz Technical University
- Investigators
- Esra Ercan, Study director, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03121872
- Sponsor's protocol ID
- 2014/21; date: 07.04.2014
- Status last verified
- Apr 2017
- First submitted
- 5 Apr 2017
- Last updated
- 24 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Predictability of Titanium-Prepared Platelet-Rich Fibrin for the Management of Multiple Gingival Recessions
- ClinicalTrials.gov ID
- NCT03121872
- Acronym / sponsor ID
- 2014/21; date: 07.04.2014
- Conditions
- Gingival Recession
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 21 May 2014 (actual)
- Primary completion
- 20 May 2016 (actual)
- Study completion
- 5 Aug 2016 (actual)
- First posted
- 20 Apr 2017 (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.
Objective: Titanium-prepared platelet-rich fibrin (T-PRF) is activated with titanium, which results in a more mature and aggregated form than PRF. In our previous studies, we established that the fibrin carpet formed with titanium had a firmer network structure, and longer resorption time in the tissue than the fibrin carpet formed with glass. The purpose of this randomized controlled clinical trial is to compare the effects of autogenous T-PRF and CTG.
Materials and methods: A total 114 Miller Class I/II gingival recessions with abrasion defects will be treated either T-PRF (63 teeth) or CTG (51 teeth) using a modified tunnel technique. Clinical periodontal indexes, keratinized tissue (KTW), gingival thickness (GT) and recession depth (RD) will be recorded before surgery and at 6 and 12-month follow-up examinations. The Visual Analog Scale and healing index scores will be assessed.
Detailed description
A total of 34 patients will be informed in detail about the risks and benefits of each step of the study, and their signed consents will be obtained.
These clinical assessments will be done:
- Plaque Index and Gingival Index In case of multiple gingival recessions, plaque index and gingival index will be obtained from the three dental points as mesial, distal and vestibule midpoints; plaque index will be calculated according to Sillnes\&Löe criteria, whereas gingival index will be calculated according to Löe\&Silness criteria.
- Periodontal Pocket Depth In case of multiple gingival recessions, the distance between the pocket base and free gingival margin will be measured separately for each tooth with the assistance of periodontal Williams probe through the midpoint of vestibule.
- Recession Width Periodontal probe will be horizontally placed on the enamel-cement border and the measurement will be recorded.
- Recession Depth The defect distance will be measured vertically from the enamel-cement conjunction of the tooth to the very apical aspect of the gingival margin using periodontal probe and recorded in millimeters.
- Clinical Attachment Level The clinical attachment level (CAL) will be measured by periodontal probe through the midpoint of vestibule as the distance between gingiva base and enamel-cement border and recorded in millimeters.
- Keratinized Tissue Width The distance between gingival margin and alveolar mucosa will be measured in millimeters. A solution consisted of 10% potassium iodide and 5% iodine will be applied onto the gingiva and alveolar mucosa with a cotton pellet. This solution stains the glycogen-rich alveolar mucosa darker than the keratinized tissue and allows keratinized gingival mucosa to be exposed more clearly.
- Gingival Thickness This measurement will be performed in the relevant area by No. 15 endodontic spreader under topical anesthesia. The spreader will be placed perpendicular to the gingiva through approximately 1.5 mm apical aspect of the gingival margin, pushed forward until obtaining bone support, and fixed with a disc. The distance between the disc and the tip of endochuck will be measured by a digital caliper with a sensitivity of 0.1 mm.
- Measurement of CTG Thickness Fat and glandular tissue and band-shape epithelium on the CTG, which will be derived from the maxillary palate, will be removed by a scissor. The graft, which will be placed onto a sterile, metal smooth surface, will be fixed through its mesial, distal and middle aspects by a No. 15 endodontic spreader with the assistance of a disc and then measured by digital caliper. The mean graft thickness will be calculated as the arithmetic mean of the values measured.
- Measurement of T-TRF Membrane Thickness Two thrombocyte rich platelets taken from the tubes that have been centrifuged will be separated from the serum at room temperature in sterile gauze and will be turned into membranes. They will be measured by digital caliper as two-layer similar to the measurement of connective tissue thickness, and the values will be recorded..
VAS Assessment On the postoperative Day 1, 3 and 7, the patients will be asked to complete a chart where they can rate subjective complaints of pain, burning sensation and discomfort in the surgery site between 0 (none) and 100 (very severe).
Wound Healing Index While removing the sutures two weeks after surgery, the physician will evaluate wound healing according to the Huang criteria separately for each tooth; Score 1: Problem-free wound healing without gingival edema, erythema, suppuration, or dehiscence of the flap margins.
Score 2. Problem-free wound healing with mild gingival edema, erythema, patient discomfort and flap dehiscence without suppuration.
Score 3. Poor wound healing with severe gingival edema, erythema, suppuration, patient discomfort and flap dehiscence.
Calculation of Root Surface Coverage Ratio This ratio is presented as percentage (%) and evaluated in the 6th and 12th months.
Preoperative recession depth - Postoperative recession depth X 100 % Preoperative recession depth
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In this randomized controlled clinical trial, multiple gingival recessions were treated by T-PRF in 16 patients and by CTG in 18 patients selected by the coin-toss method. All surgical procedures, measurements and follow-up were performed by the same clinician
| Arm | Type | Receives |
|---|---|---|
| Root Coverage Surgery with T-PRF | Experimental | Procedure: Root Coverage Surgery with T-PRFMultiple gingival recessions were treated by Titanium prepared PRF (T-PRF) in 16 patients. The T-PRF membrane that was procured was placed in the defect area 1 mm beyond the enamel-cement border.. The T-PRF was fixed in the receiver area by a mattress stitch through the apical aspect using 5-0 monofilament absorbable sutures. The flap was stitched in a manner that completely covered the graft in the coronal aspect. Thereafter, the graft was fixed to the flap on the coronal aspect with horizontal mattress sutures. Compression was applied to the receiver area with serum-impregnated sterile gauze for approximately 5 minutes, and then periodontal paste was placed onto the surgery site. |
| Root Coverage Surgery with CTG | Active comparator | Procedure: Root Coverage Surgery with CTGMultiple gingival recessions were treated by Connective Tissue Graft (CTG)in 18 patients.The CTG width was measured to include 1 mm beyond the root surface defects in the receiver area. Following anaesthesia of the palate, the borders of the start and finish incisions were marked. Subepithelial connective tissue that was 1.5-2 mm thick and excluded the periosteum was removed and maintained in physiological saline. The palate was stitched with 4-0 absorbable sutures (Pegalak, Doğsan, Turkey) and covered with a periodontal paste. Before placing the connective tissue in the receiver area, the fat and glandular tissues and the band-shaped epithelium on the connective tissue were removed using scissors. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Absence of systemic disease that would likely hinder periodontal surgery or unfavourably influence wound healing
- Having multiple gingival recessions including at least two adjacent Miller class I or II teeth among mandibular or maxillary incisors and premolars. Molars were excluded.
- The teeth undergoing treatment were vital with no restoration or decay in the tooth neck (collum dentis) and with a completely or partially fixable enamel-cement border
- The relevant teeth in the arch were rotation-free with no mobility
- The presence of periodontal pockets not exceeding 3 mm in the teeth undergoing treatment; the teeth had no occlusal trauma; and the patients were older than 18 years of age
Key exclusion criteria (4 listed)
- Receiving medicines that would likely cause gingival hypertrophy
- Smokers
- Presence of blood-borne diseases
- Presence of any systemic disease likely to influence coagulation, and receiving any anticoagulant medicines
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 |
|---|---|---|
| Root Coverage Surgery with T-PRFRoot surfaces in the multiple gingival recession regions were made smooth using Gracey curettes. To remove the smear layer, 24% EDTA solution was applied to the tooth surfaces for approximately 2 minutes and then washed with physiological saline. The receiver region was prepared using the modified tunnel method. After passive stabilization of the flap in the coronal aspect, the preparation of the donor region was initiated | Procedure or surgery | Root Coverage Surgery with T-PRF |
| Root Coverage Surgery with CTGRoot surfaces in the multiple gingival recession regions were made smooth using Gracey curettes. To remove the smear layer, 24% EDTA solution was applied to the tooth surfaces for approximately 2 minutes and then washed with physiological saline. The receiver region was prepared using the modified tunnel method. After passive stabilization of the flap in the coronal aspect, the preparation of the donor region was initiated | Procedure or surgery | Root Coverage Surgery with CTG |
Primary outcome
Root Coverage Percentage at 12 months
Time frame: Change from baseline Root Coverage Percentage at 12 months
Preoperative recession depth - Postoperative recession depth X 100 % Preoperative recession depth
1 secondary outcome
Keratinized Tissue Width at 12 months
Time frame: Change from baseline Keratinized Tissue Width at 12 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 24 Apr 2017.
- Individual participant dataSharing planned: No
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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.
Esra Ercan study director
Karadeniz Technical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Root Coverage Surgery with T-PRF and Root Coverage Surgery with CTG in people with Gingival Recession, run by Karadeniz Technical 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 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 24 Apr 2017. 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?
Root Coverage Percentage at 12 months (time frame: Change from baseline Root Coverage Percentage at 12 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 24 Apr 2017.