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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06366022
Other study ID # Warsaw.06
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 30, 2023
Est. completion date May 30, 2024

Study information

Verified date April 2024
Source Medical University of Warsaw
Contact Nela Molga-Chlipala
Phone 48604286899
Email nela.molga@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Microsurgical coronally advanced tunnel procedures using subepithelial connective tissue grafts (sCTG) are predictable for healing of multiple adjacent type 1 and 2 gingival recessions (RT1 and RT2). In order to reduce patient morbidity and enhance periodontal wound healing with sCTG can be used. The aim of this study is to compare the results of the modified tunneling technique with subepithelial connective tissue graft in gingival recessions placed with the inner side towards the flap cover graft and the outer side towards the flap cover graft.


Description:

Condition or disease:Multiple Gingival Recession Intervention/treatment: Device: Modified coronally advanced tunnel with connective tissue graft placed with inner side towards the flap Device: Modified coronally advanced tunnel with subepithelial connective tissue graft with the outer side towards the flap Phase :Not Applicable


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date May 30, 2024
Est. primary completion date May 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Age = 18 years - Bilateral multiple gingival recessions in homologous teeth in the same arch. Exclusion Criteria: - Full-mouth plaque index = 20% (Ainamo & Bay 1975) - Full-mouth sulcus bleeding index = 15% (Mühlemann & Son 1971) - Smoking - Systemic diseases with compromised healing potential of infectious diseases - Drugs affecting periodontal health / healing - Pregnant and lactating females - Previous periodontal surgery in the area

Study Design


Related Conditions & MeSH terms


Intervention

Device:
The tunnel technique for root coverage with CTG with inner side of the graft
Procedure: The tunnel technique for root coverage with CTG with inner side of the graft
The tunnel technique for root coverage with CTG with outer side of the graft
The tunnel technique for root coverage with CTG with outer side of the graft

Locations

Country Name City State
Poland Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw Warsaw MAzowsze

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical attachment level (CAL) Distance from the cementoenamel junction to the bottom of the gingival sulcus Time Frame: 6 months after surgery
Primary Recession height (RH) Distance from the cementoenamel junction to the gingival margin Time Frame: 6 months after surgery
Primary Recession width (RW) Distance measured horizontally at cementoenamel junction level from one border of the recession to another Time Frame: 6 months after surgery
Primary Width of keratinized tissue (KTW) Distance between the most apical point of the gingival margin and the mucogingival junction Time Frame: 6 months after surgery
Primary Thickness of keratinized tissue (GT Thickness of the gingiva measured 2 mm apical to the gingival margin Time Frame: 6 months after surgery
Primary Average recession coverage (ARC) The percentage of covered recession area Time Frame: 6 months after surgery
Primary Complete recession coverage The percentage of sites with complete root coverage Time Frame: 6 months after surgery
Secondary Probing pocket depth (PPD) Distance from the gingival margin to the bottom of the gingival sulcus Time Frame: 6 months after surgery
Secondary Root coverage esthetic score (RES) A score including root coverage, marginal gingival tissue contour, mucogingival junction alignment, soft tissue texture and gingival colour according to Cairo et al. (1999) Time Frame: 6 months after surgery
Secondary Post surgical pain and swelling Questionnaire about post surgical pain and swelling using a Visual Analog Scale with values 0 (no pain / swelling), 1, 2, 3, 4, 5(moderate pain/swelling), 6, 7, 8, 9, 10 (worst pain / swelling). Lower values represent lower post surgical discomfort and are considered better. Time Frame:, 7 and 14 days after surgery
Secondary Patient's satisfaction with treatment Questionnaire about patient's esthetic perception of gingiva and overall satisfaction using a Visual Analog Scale from 0 (dissatisfaction with esthetic outcome), 2, 3, 4, 5 (moderate satisfaction with easthetic outcome), 6, 7, 8, 9, 10 (best satisfaction with esthetic outcome). Higher values are considered better. Time Frame: 6 months after surgery ]
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