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

Gingival Recession Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06357351
• Other study ID #: VISTA in gingival recession
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: May 2024

Study information

• Verified date: April 2024
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: May 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gingival Recession

Intervention

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)

Locations

Country	Name	City	State
Egypt	Mansoura university	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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