Evaluation of Esthetic Root Coverage Using Platelet-Rich Fibrin Versus Subepithelial Connective Tissue Graft With Vestibular Incision Subperiosteal Tunnel Access in Multiple Gingival Recessions
1 other identifier
interventional
28
0 countries
N/A
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2018
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 25, 2018
CompletedFirst Posted
Study publicly available on registry
July 17, 2018
CompletedStudy Start
First participant enrolled
August 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 20, 2019
CompletedJuly 17, 2018
July 1, 2018
6 months
June 25, 2018
July 3, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Amount of root coverage
complete root coverage after surgical correction measured in millimeters by using periodontal probe
6 months
Secondary Outcomes (8)
Root Coverage Esthetic score a numbering score
6 months
Post-Operative Pain a numerical rating scale
14 days
Post-Operative Swelling verbal rating scale
7 days
Post-Surgical Patient Satisfaction numerical rating scale
14 days
Clinical Attachment level gain in millimeters
6 months
- +3 more secondary outcomes
Study Arms (2)
VISTA using PRF
EXPERIMENTALVestibular 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 COMPARATORvestibular 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
Interventions
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
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
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mona Darhous, Phd
Cairo University
- STUDY CHAIR
Ahmed El-Barbary, Phd
Cairo University
- STUDY CHAIR
Marwa Hegab, Phd
Cairo University
- PRINCIPAL INVESTIGATOR
Yasmin Sery, Bachelor
Cairo University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- B.Sc. in Oral and Dental Medicine
Study Record Dates
First Submitted
June 25, 2018
First Posted
July 17, 2018
Study Start
August 1, 2018
Primary Completion
February 1, 2019
Study Completion
February 20, 2019
Last Updated
July 17, 2018
Record last verified: 2018-07