Evaluation of Patient Morbidity and Root Coverage Outcomes of VISTA Versus CAF in Treating Gingival Recession

NCT06723314 | Completed

• 1 other identifier: 19/2017
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate and compare Vestibular Incision Subperiosteal Tunnel Access (VISTA) technique,with connective tissue graft; versus Coronally Advanced Flap (CAF) technique;with connective tissue graft, in treating gingival recession in esthetic zone. Patients and Methods: Thirty patients, with Miller class I or class II gingival recession, were included in the current study, with age range from 18 to 55 years. Defects were treated using either VISTA combined with connective tissue graft technique, or CAF combined with connective tissue technique. Post-operative discomfort was evaluated using the Visual Analog Scale (VAS) to assess patient morbidity. At baseline, 3, 6 and 9 months, clinical parameters were assessed; Probing Depth (PD), Clinical Attachment Level (CAL), Gingival recession Height (GH), Keratinized Tissue Height (KTH), while Complete and Mean Root Coverage (CRC, MRC) were recorded after nine months. Results: The present study revealed that VISTA showed higher significant difference in pain.VISTA also showed a more reduction in PD, CAL, GH as well as KTH than that of CAF with no significant difference between either of the groups.

Conditions

Esthetic Zone

Keywords

recession , gingival recession; connective tissue graft; coronally advanced flap; patient morbidity

Outcome Measures

Primary Outcomes (1)

• Pain Score

  Visual Analogue Scale to measure pain from (0-10) with 0 (no pain) and 10 (worst pain)

  1-10 days

Study Arms (2)

Vestibular Subperiosteal Tunnel Access

EXPERIMENTAL

Vestibular Subperiosteal Tunnel Access

Procedure: Vestibular Subperiosteal Tunnel Access vista

Coronally Advanced Flap

ACTIVE COMPARATOR

Coronally Advanced Flap

Procedure: Vestibular Subperiosteal Tunnel Access vista

Interventions

Vestibular Subperiosteal Tunnel Access vista PROCEDURE

CAF procedures were performed (Split-Full-Split flap), following the anesthetic agent, the sulcular incision was performed by a full thickness vertical incision till the muccogingival junction• Split thickness releasing incision was made at the flap base with full thickness flap reflection till the muccogingival junction.

Also known as: coronally advanced flap

Coronally Advanced Flap; Vestibular Subperiosteal Tunnel Access

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18- 55 years
• No sexual discrepancy
• Medically free
• Good oral hygeine
• Sound teeth with single (measuring ≥ 2 mm) or Multiple (measuring ≥ 1 mm)
• Class I or II gingival recession defects and adequate amount of keratinized tissue (3mm width).

You may not qualify if:

• Patients on anticoagulants, antiplatelets, or glucocorticoids.
• Pregnant females or lactating female patients
• Smoking patients.
• Patients with parafunctional habits.
• Tooth extraction in the surgical sites, active periodontal disease or history of previous surgery in the same area.

Sponsors & Collaborators

• Misr International University: lead

Study Sites (1)

Misr International Unversity

Cairo, 4651010, Egypt

Location

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The surgeon performing the surgical technique as well as the patient cannot be blinded because the two surgical procedures are different and recognizable by both the surgeon and the patient after being well informed
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 9, 2024
• Study Start: January 15, 2018
• Primary Completion: January 10, 2020
• Study Completion: October 15, 2020
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)