Comparison of Using Collagen Membrane and A-PRF Using VISTA Technique in Gingival Recession Treatment

Comparative Evaluation of Vestibular Incision Subperiosteal Tunnel Access With Advanced Platelet-rich Fibrin and Collagen Membrane in the Treatment of Gingival Recession Defects

To assess the efficacy of minimally invasive Vestibular Incision Subperiosteal Tunnel Access (VISTA) with collagen membrane and Advanced Platelet-rich Fibrin (A-PRF) in the treatment of multiple buccal gingival recession type 1(RT1) Cairo Classification.

Study Overview

• Status: Active, not recruiting
• Conditions: Gingival Recession
• Intervention / Treatment: Procedure: vestibular incision sub periosteal tunnel access ( VISTA) technique.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Mansoura, Egypt
    • Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• (18-50) years old with at least 2 sites with gingival recession type (RT1) Cairo Classification (GR with no interdental attachment loss). The interdental CEJ is not detectable clinically on the labial surfaces of the teeth.
• Recession in the maxillary anterior region ≥1 mm of attached gingiva, pocket depth (PD) of <3 mm, recession depth (RD) ≥2 mm, and gingival index (GI) score ≤1.
• Systemically healthy, willing individuals with good oral hygiene and without contraindications for surgical interventions

Exclusion Criteria:

• the presence of severe systematic diseases or immunodeficiency and contraindicated with surgical interventions.
• Allergies to medicaments used in the treatment process.
• Patients with removable or fixed dentures.
• Patients with cervical abrasion, direct and indirect restorations involving the cervical areas of the maxillary anterior.
• Participants with smoking, tobacco chewing, and alcohol consumption.
• The presence of high frenal attachment and participants who had previously undergone any periodontal surgical procedure or regenerative therapy in the past 1 year at the same site of the planned treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VISTA technique and collagen membrane; Participants undergo periodontal surgery using the vestibular incision sub-periosteal tunnel access technique (VISTA) and collagen membrane.	Procedure: vestibular incision sub periosteal tunnel access ( VISTA) technique.; In comparison between the two groups, the first group uses collagen membrane and the other group uses advanced PRF using the same surgical technique (VISTA)
Experimental: VISTA technique and advanced platelet rich fibrin; Participants undergo periodontal surgery using the vestibular incision sub-periosteal tunnel access technique (VISTA) and advanced platelet-rich fibrin (A-PRF).	Procedure: vestibular incision sub periosteal tunnel access ( VISTA) technique.; In comparison between the two groups, the first group uses collagen membrane and the other group uses advanced PRF using the same surgical technique (VISTA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measuring the recession width in millimeter	self-report assessment by using the UNC-15 Periodontal Probe, measured at the level of Cemento-Enamel Junction CEJ.	baseline, 3 months and 6 months
Measuring the recession depth in millimeter	self-report assessment by using the UNC-15 Periodontal Probe, measured from the cemento-enamel junction CEJ to the free gingival junction.	baseline, 3 months and 6 months
Measuring the width of keratinized gingiva in millimeter	self-report assessment by using the UNC-15 Periodontal Probe. measured from the free gingiva margin to the mucogingival junction.	baseline, 3 months and 6 months
Mean of root coverage	was measured by the following formula:. Mean root coverage formula: (pre-operative recession depth - post-operative recession depth)/(pre-operative recession depth ) ×100	baseline, and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measuring the probing depth	self-report assessment by using the UNC-15 Periodontal Probe. Measured from the free gingival margin to the base of the sulcus.	baseline, 3 months and 6 months
Measuring the plaque index	According to Silness and Leo, this index determines the thickness of the plaque along the gingival margin. possible score range from 0 (no plaque) to 1 ( thin plaque located at gingival margin only detected by periodontal probe), 2 ( moderate plaque thickness detected by naked eye located at gingival margin), and 3 ( abundant plaque thickness at gingival margin and interproximal area)	baseline, 3 months and 6 months
Measuring the gingival index	According to Silness and Leo, this index determines the description of the gingiva of examined teeth. possible score range from 0 (normal gingiva) to 1 (mild inflammation; slight erythema; no bleeding.) / 2 (moderate inflammation; erythema and bleeding on probing) or 3 (severe inflammation; severe erythema, swelling, and spontaneous bleeding).	baseline, 3 months and 6 months
Clinical attachment level	self-report assessment by using the UNC-15 Periodontal Probe, measured from the cemento-enamel junction to the base of the pocket.	baseline, 3 months and 6 months

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: April 4, 2024
• First Submitted That Met QC Criteria: April 9, 2024
• First Posted (Actual): April 10, 2024

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: VISTA in gingival recession

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No