Gingival RecessionNCT03588052
Evaluation of Esthetic Root Coverage Using Platelet-Rich Fibrin Versus Subepithelial Connective Tissue Graft With Vestibular Incision Subperiosteal Tunnel Access in Multiple Gingival Recessions
A study testing VISTA using PRF and VISTA using SCTG in people with Gingival Recession, run by Cairo University.
Trial summary
Patients with gingival recession, complain of excessive tooth length that affects their appearance during smiling or functioning. The main goal of plastic periodontal surgeries is to restore patient's esthetic demands with the regeneration of gingival and periodontal tissues. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- VISTA using PRF and VISTA using SCTG
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2018to 20 Feb 2019
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Multiple adjacent maxillary or mandibular gingival recessions Miller class І or II
- Good oral hygiene with full mouth plaque score (FMPS) ≤ 20% (O'Leary et al. 1972)
Who cannot join
- Any systemic condition that may contraindicate periodontal surgery
- Individuals taking medications that interfere with periodontal tissue health or healing
- Previous periodontal plastic surgery in the selected sites for at least 6 months before the study
- Pregnancy or lactating women
- Former or current smokers
- Active periodontal disease
- Non-compliant patients.
- Any restorations found in the selected sites
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Esthetic Root Coverage Using Platelet-Rich Fibrin Versus Subepithelial Connective Tissue Graft With Vestibular Incision Subperiosteal Tunnel Access Technique in Patients With Multiple Gingival Recessions: A Randomized Controlled Clinical Trial
Patients with gingival recession, complain of excessive tooth length that affects their appearance during smiling or functioning. The main goal of plastic periodontal surgeries is to restore patient's esthetic demands with the regeneration of gingival and periodontal tissues.
Although SCTG is considered a gold standard, it has its own limitations like patient morbidity and graft availability. Consequently, PRF has been introduced in an attempt to overcome the drawbacks of SCTG and achieve optimum results in root coverage.
The minimally invasive VISTA technique allows better access with coronal positioning and stabilization of gingival margin to achieve complete root coverage. In addition to platelets-rich fibrin that gives a predictable and reproducible result in restoring the amount of keratinized tissue, root coverage and better esthetic outcome. The use Vestibular incision subperiosteal tunneling access (VISTA) with platelet-rich fibrin will be used to achieve complete root coverage.
Read the detailed description
Gingival recession is defined as apical displacement of gingival margin beyond the cementoenamel junction leading to the exposure of root surface. There are various etiologic factors for gingival recession like trauma, infection and other anatomical factors.
Nowadays, periodontal plastic surgeries for treatment of gingival recession have become an important array due to increase in patient's esthetic demands and other conditions such as dentin hypersensitivity, root caries or abrasion, keratinized tissue augmentation and gingival margin discrepancy.
Subepithelial connective tissue grafts (SCTG) are considered the gold standard to obtain maximum root coverage due to its characteristics of quick keratinization and periodontal connective tissue adherence, in addition to its good blood supply to the graft and high degree of gingival color match and esthetics. However, the application of this technique is limited by the thickness of the donor tissue, anatomical factors, limited quantity compromising their use in multiple recession, tissue morbidity, and technique sensitive with postoperative pain, bleeding and swelling.
Accordingly, alternative membranes and new biomaterials have been introduced to overcome the limitations of SCTG.
Platelet rich fibrin (PRF) was introduced; a second generation platelet concentrate. PRF contains growth factors that play an essential role in soft and hard tissue regeneration; they promote fibroblastic proliferation, increase tissue vascularization, enhance soft tissue healing potential and accelerate bone regeneration. These growth factors include (PDGFs), epidermal growth factor (EGF), transforming growth factor beta (TGF-β), vascular endothelial growth factor (VEGF).
Vestibular incision subperiosteal tunnel access (VISTA), a novel minimal invasive technique for achieving root coverage that overcome the limitation of the previous intrasulcular tunneling techniques.
Hence this study will performed to evaluate the use of PRF in conjunction with VISTA technique in management of patients with multiple gingival recessions
- Conditions
- Gingival Recession
- Being tested
- VISTA using PRF, VISTA using SCTG
- Keywords
- Vestibular incision subperiosteal tunnel access, Subepithelial connective tissue graft, Platelets rich fibrin, Multiple gingival recessions
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VISTA using PRFProcedure or surgery
Also called Vestibular incision subperiosteal tunnel access technique with Platelet-rich fibrin
Vertical vestibular access incision will be done through the periosteum to elevate a subperiosteal tunnel, exposing the facial osseous plate. The tunnel will be extended beyond mucogingival junction and at least one or two teeth beyond the teeth indicated for root coverage to mobilize gingival margins and allow for low-tension coronal repositioning of the gingiva.
Freshly prepared platelet-rich fibrin will be secured in the tunnel to cover the root dehiscence, coronal advancement of gingival margin and suturing to the facial aspect of each tooth to avoid apical relapse of the gingival margin during the initial phase of healing. The vertical incision will be then approximated and sutured
VISTA using SCTGProcedure or surgery
Also called Vestibular incision subperiosteal tunnel access technique with Subepithelial connective tissue graft
Vertical vestibular access incision will be done through the periosteum to elevate a subperiosteal tunnel, exposing the facial osseous plate. The tunnel will be extended beyond mucogingival junction and at least one or two teeth beyond the teeth indicated for root coverage to mobilize gingival margins and allow for low-tension coronal repositioning of the gingiva.
Subepithelial connective tissue graft will be secured in the tunnel to cover the root dehiscence, coronal advancement of gingival margin and suturing to the facial aspect of each tooth to avoid apical relapse of the gingival margin during the initial phase of healing. The vertical incision will be then approximated and sutured
| Study group | Role | What they receive |
|---|---|---|
| VISTA using PRF | Experimental | Vestibular incision subperiosteal tunnel access combined with Platelets-Rich Fibrin
An intravenous blood will be drawn from the patient in a glass-coated plastic tubes, centrifuged at 3000 rpm for 10-12 min. A Platelets rich fibrin membrane will then be obtained Receives: Procedure: VISTA using PRF |
| VISTA using SCTG | Active comparator | vestibular incision subperiosteal tunnel access combined with subepithelial connective tissue graft
Subepithelial connective tissue graft will be harvested from the palate, secured in the tunnel to cover the root dehiscence then sutured Receives: Procedure: VISTA using SCTG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of root coverage
complete root coverage after surgical correction measured in millimeters by using periodontal probe
Measured: 6 months
Secondary outcomes (8)
Root Coverage Esthetic score a numbering score
A scoring system to evaluate esthetics after surgical root coverage giving a numbering score by a periodontal probe
Measured: 6 months
Post-Operative Pain a numerical rating scale
Numerical Rating Scale (NRS) with numbers from 0 to 10 ('no pain' to 'worst pain imaginable')for the first 2 weeks postoperatively.
Measured: 14 days
Post-Operative Swelling verbal rating scale
Verbal Rating Scale (VRS); absent(no swelling), slight (intraoral swelling at the operated area), moderate (moderate intraoral swelling at the operated area) and intense (intensive extraoral swelling extending beyond the operated area)
Measured: 7 days
Post-Surgical Patient Satisfaction numerical rating scale
A numerical rating scale will be used. A 3-item questionnaire is asked and the patients shall use a 7 point answer scale.
Measured: 14 days
Clinical Attachment level gain in millimeters
the clinical attachment level is the measurement of the position of the soft tissue in relation to the cemento-enamel junction (CEJ). Two measurements are used to calculate the CAL: the probing depth and the distance from the gingival margin to the CEJ. measured using a periodontal probe in millimeters.
Measured: 6 months
Probing depth in millimeters
It is measuring the distance from the gingival margin to the base of the pocket using periodontal probe. The probe will be inserted parallel to the long axis of the tooth using light force.
Measured: 6 months
Keratinized Tissue Width in millimeters
It is measured from the free gingival margin to the mucogingival junction (MGJ). By using the periodontal probe, MGJ will be identified using the roll technique
Measured: 6 months
Gingival Thickness in millimeters
It is measured by penetrating the gingiva mid-buccally in the attached gingiva, half way between mucogingival junction and free gingival groove to measure the gingival thickness
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 posted17 Jul 2018
- Study start1 Aug 2018 (estimated)
- Primary completion1 Feb 2019 (estimated)
- Study completion20 Feb 2019 (estimated)
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 Cairo 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
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmin Medhat Sery, Cairo University
- Investigators
- Mona Darhous, Phd, Study director, Cairo UniversityAhmed El-Barbary, Phd, Study chair, Cairo UniversityMarwa Hegab, Phd, Study chair, Cairo UniversityYasmin Sery, Bachelor, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03588052
- Sponsor's protocol ID
- 4061989
- Status last verified
- Jul 2018
- First submitted
- 25 Jun 2018
- Last updated
- 17 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Esthetic Root Coverage Using Platelet-Rich Fibrin Versus Subepithelial Connective Tissue Graft With Vestibular Incision Subperiosteal Tunnel Access Technique in Patients With Multiple Gingival Recessions: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03588052
- Acronym / sponsor ID
- 4061989
- Conditions
- Gingival Recession
- Keywords
- Vestibular incision subperiosteal tunnel access, Subepithelial connective tissue graft, Platelets rich fibrin, Multiple gingival recessions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2018 (estimated)
- Primary completion
- 1 Feb 2019 (estimated)
- Study completion
- 20 Feb 2019 (estimated)
- First posted
- 17 Jul 2018 (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.
Patients with gingival recession, complain of excessive tooth length that affects their appearance during smiling or functioning. The main goal of plastic periodontal surgeries is to restore patient's esthetic demands with the regeneration of gingival and periodontal tissues.
Although SCTG is considered a gold standard, it has its own limitations like patient morbidity and graft availability. Consequently, PRF has been introduced in an attempt to overcome the drawbacks of SCTG and achieve optimum results in root coverage.
The minimally invasive VISTA technique allows better access with coronal positioning and stabilization of gingival margin to achieve complete root coverage. In addition to platelets-rich fibrin that gives a predictable and reproducible result in restoring the amount of keratinized tissue, root coverage and better esthetic outcome. The use Vestibular incision subperiosteal tunneling access (VISTA) with platelet-rich fibrin will be used to achieve complete root coverage.
Detailed description
Gingival recession is defined as apical displacement of gingival margin beyond the cementoenamel junction leading to the exposure of root surface. There are various etiologic factors for gingival recession like trauma, infection and other anatomical factors.
Nowadays, periodontal plastic surgeries for treatment of gingival recession have become an important array due to increase in patient's esthetic demands and other conditions such as dentin hypersensitivity, root caries or abrasion, keratinized tissue augmentation and gingival margin discrepancy.
Subepithelial connective tissue grafts (SCTG) are considered the gold standard to obtain maximum root coverage due to its characteristics of quick keratinization and periodontal connective tissue adherence, in addition to its good blood supply to the graft and high degree of gingival color match and esthetics. However, the application of this technique is limited by the thickness of the donor tissue, anatomical factors, limited quantity compromising their use in multiple recession, tissue morbidity, and technique sensitive with postoperative pain, bleeding and swelling.
Accordingly, alternative membranes and new biomaterials have been introduced to overcome the limitations of SCTG.
Platelet rich fibrin (PRF) was introduced; a second generation platelet concentrate. PRF contains growth factors that play an essential role in soft and hard tissue regeneration; they promote fibroblastic proliferation, increase tissue vascularization, enhance soft tissue healing potential and accelerate bone regeneration. These growth factors include (PDGFs), epidermal growth factor (EGF), transforming growth factor beta (TGF-β), vascular endothelial growth factor (VEGF).
Vestibular incision subperiosteal tunnel access (VISTA), a novel minimal invasive technique for achieving root coverage that overcome the limitation of the previous intrasulcular tunneling techniques.
Hence this study will performed to evaluate the use of PRF in conjunction with VISTA technique in management of patients with multiple gingival recessions
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VISTA using PRF | Experimental | Procedure: VISTA using PRFVestibular incision subperiosteal tunnel access combined with Platelets-Rich Fibrin An intravenous blood will be drawn from the patient in a glass-coated plastic tubes, centrifuged at 3000 rpm for 10-12 min. A Platelets rich fibrin membrane will then be obtained |
| VISTA using SCTG | Active comparator | Procedure: VISTA using SCTGvestibular incision subperiosteal tunnel access combined with subepithelial connective tissue graft Subepithelial connective tissue graft will be harvested from the palate, secured in the tunnel to cover the root dehiscence then sutured |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Multiple adjacent maxillary or mandibular gingival recessions Miller class І or II
- Good oral hygiene with full mouth plaque score (FMPS) ≤ 20% (O'Leary et al. 1972)
Key exclusion criteria (8 listed)
- Any systemic condition that may contraindicate periodontal surgery
- Individuals taking medications that interfere with periodontal tissue health or healing
- Previous periodontal plastic surgery in the selected sites for at least 6 months before the study
- Pregnancy or lactating women
- Former or current smokers
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 |
|---|---|---|
| VISTA using PRFAlso: Vestibular incision subperiosteal tunnel access technique with Platelet-rich fibrinVertical vestibular access incision will be done through the periosteum to elevate a subperiosteal tunnel, exposing the facial osseous plate. The tunnel will be extended beyond mucogingival junction and at least one or two teeth beyond the teeth indicated for root coverage to mobilize gingival margins and allow for low-tension coronal repositioning of the gingiva. Freshly prepared platelet-rich fibrin will be secured in the tunnel to cover the root dehiscence, coronal advancement of gingival margin and suturing to the facial aspect of each tooth to avoid apical relapse of the gingival margin during the initial phase of healing. The vertical incision will be then approximated and sutured | Procedure or surgery | VISTA using PRF |
| VISTA using SCTGAlso: Vestibular incision subperiosteal tunnel access technique with Subepithelial connective tissue graftVertical vestibular access incision will be done through the periosteum to elevate a subperiosteal tunnel, exposing the facial osseous plate. The tunnel will be extended beyond mucogingival junction and at least one or two teeth beyond the teeth indicated for root coverage to mobilize gingival margins and allow for low-tension coronal repositioning of the gingiva. Subepithelial connective tissue graft will be secured in the tunnel to cover the root dehiscence, coronal advancement of gingival margin and suturing to the facial aspect of each tooth to avoid apical relapse of the gingival margin during the initial phase of healing. The vertical incision will be then approximated and sutured | Procedure or surgery | VISTA using SCTG |
Primary outcome
Amount of root coverage
Time frame: 6 months
complete root coverage after surgical correction measured in millimeters by using periodontal probe
8 secondary outcomes
Root Coverage Esthetic score a numbering score
Time frame: 6 months
Post-Operative Pain a numerical rating scale
Time frame: 14 days
Post-Operative Swelling verbal rating scale
Time frame: 7 days
Post-Surgical Patient Satisfaction numerical rating scale
Time frame: 14 days
Clinical Attachment level gain in millimeters
Time frame: 6 months
Probing depth in millimeters
Time frame: 6 months
Keratinized Tissue Width in millimeters
Time frame: 6 months
Gingival Thickness in millimeters
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
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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.
Mona Darhous, Phd study director
Cairo University
Ahmed El-Barbary, Phd study chair
Cairo University
Marwa Hegab, Phd study chair
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing VISTA using PRF and VISTA using SCTG in people with Gingival Recession, run by Cairo 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 2 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 17 Jul 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yasmin Medhat Sery, Bachelor ((+2) 01060122275, Yasmin.sery@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of 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 17 Jul 2018.