Evaluation of the Treatment of Multiple Gingival Recession Using Modified Coronally Advanced Tunnel With Subepithelial Connective Tissue Graft Depending on the Positioning of the Graft

Gingival Recession Clinical Trial

Official title:

Evaluation of the Treatment of Multiple Gingival Recession Using Modified Coronally Advanced Tunnel With Subepithelial Connective Tissue Graft Depending on the Positioning of the Graft

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06366022
• Other study ID #: Warsaw.06
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Gingival Recession

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 ]