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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06433986
Other study ID # Rohan Goyal Perio 24/35
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 1, 2024
Est. completion date December 31, 2025

Study information

Verified date May 2024
Source Postgraduate Institute of Dental Sciences Rohtak
Contact SHIKHA TEWARI, MDS
Phone 9416514600
Email drshikhatewari@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to compare MCAT technique (supraperiosteal approach with coronal advancement of flap) with VISTA technique(subperiosteal approach with coronal advancement of flap), Further, it may be hypothesized that supraperiosteal placement of graft material (in MCAT technique) may be better due to better blood supply, and MCAT technique utilizes a microsurgical concept, including microsurgical blades and suture material, which improves wound healing and establishes a better esthetic result and results in better outcome in terms of root coverage percentage compared to VISTA. Therefore, this study aims to compare minimally invasive technique MCAT and VISTA using VCMX as a graft in RT3 gingival recession in anterior teeth.


Description:

Gingival recession is the migration of the gingiva to a point apical to the cement-enamel junction and is considered one of the most common periodontal problems.Besides aesthetic complaints, GR may also cause root hypersensitivity, risk for development of caries or non-carious cervical lesions, and difficulties to achieve optimal plaque control. In modified coronally advanced Tunnel (MCAT) technique partial-thickness flap is created on the entire buccal aspect, no parts of the alveolar bone are exposed, and resorption of bony structures, which occurs when using a full-thickness flap can be avoided, also,it minimizes trauma and ensure a better blood supply for the graft. Zadeh H. in 2011 introduced a conservative modification in tunnel technique; vestibular incision subperiosteal tunnel access (VISTA) which preserve the papillary integrity and enhances patients compliance. Vista technique allows gingival tissue regeneration through subperiosteal undermining of soft tissues using a vestibular incision instead of elevating the whole flap.VISTA offers broader access and maximum esthetic outcome because of placement of incision in the frenum region.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 34
Est. completion date December 31, 2025
Est. primary completion date September 30, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility INCLUSION CRITERIA- - Patients with RT 3 isolated recession defects present Labially in Anterior teeth region,with vestibular depth>=6mm - Systemically healthy individuals. - Age >18 years old. - A full mouth plaque score (FMPS) and full mouth BOP (FMBOP) < 20% - Patient showing adequate compliance and willing to participate in the study. EXCLUSION CRITERIA- - Patients having systemic disease such as hypertension, diabetes, hyperthyroidism or on medication that influence the outcome of periodontal therapy. - Previous surgical attempt to correct gingival recession. - Crowding of affected teeth and tooth without adjacent contact teeth. - Patients with active periodontal disease. - Smokers and tobacco users. - Pregnant and lactating women. - Involved tooth with trauma from occlusion - Involved tooth with prosthesis. - Endodontically treated tooth. - Tooth with cervical abrasion/undetectable CEJ/ caries.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Modified Coronally Advanced Tunnel (MCAT)Technique
Scaling and root planing will be performed and after resolution of gingival inflammation, root coverage procedure will be done with Volume Stable Collagen Matrix(VCMX) using MCAT.
Vestibular Incision Subperiosteal Tunnel Access (VISTA)Technique
Scaling and root planing will be performed and after resolution of periodontal inflammation, root coverage procedure will be done with Volume Stable Collagen Matrix(VCMX) using VISTA.

Locations

Country Name City State
India PGIDS Rohtak Haryana

Sponsors (1)

Lead Sponsor Collaborator
Postgraduate Institute of Dental Sciences Rohtak

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Root coverage percentage percentage of root coverage will be calculated by using pre and post operative recession depth 6 months
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