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

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.

Study Overview

• Status: Recruiting
• Conditions: Gingival Recession
• Intervention / Treatment: Device: The tunnel technique for root coverage with CTG with inner side of the graft; Device: The tunnel technique for root coverage with CTG with outer side of the graft

Detailed 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

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nela Molga-Chlipała; Phone Number: 48604286899; Email: nela.molga@gmail.com
• Study Contact Backup: Name: Bartłomiej Górski, PhD; Phone Number: 0048221166431; Email: gorskibartlomiej04@gmail.com

Study Locations

• Poland
  • MAzowsze
    • Warsaw, MAzowsze, Poland, 00-246
      • Recruiting
      • Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw
      • Contact: Bartłomiej Górski, PhD; Phone Number: 48225022099

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multiple adjacent recessions coverage with sCTG with inner side of the graft; Experimental: Multiple adjacent recessions coverage with subepithelial connective tissue graft.. A modified microsurgical tunnel technique. Initial sulcular incisions with a microsurgical blade are followed by a full-thickness buccal flap preparations till muco-gingival junction using the tunneling knives. Subsequently, the split-thickness preparation is extended into the mucosal tissue to gain sufficient flap mobility. The papillary regions are detached in their buccal aspects with the periosteum. The graft is inserted the inner side into the tunnel and stabilized with absorbable suspensory sutures. The buccal flap is advanced coronally and stabilized with non-absorbable suspensory sutures.	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
Active Comparator: Multiple adjacent recessions coverage with sCTG with outer side of the graft; Multiple adjacent recessions coverage with subepithelial connective tissue graft.. A modified microsurgical tunnel technique. Initial sulcular incisions with a microsurgical blade are followed by a full-thickness buccal flap preparations till muco-gingival junction using the tunneling knives. Subsequently, the split-thickness preparation is extended into the mucosal tissue to gain sufficient flap mobility. The papillary regions are detached in their buccal aspects with the periosteum. The graft is inserted the outer side into the tunnel and stabilized with absorbable suspensory sutures. The buccal flap is advanced coronally and stabilized with non-absorbable suspensory sutures.	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical attachment level (CAL)	Distance from the cementoenamel junction to the bottom of the gingival sulcus	Time Frame: 6 months after surgery
Recession height (RH)	Distance from the cementoenamel junction to the gingival margin	Time Frame: 6 months after surgery
Recession width (RW)	Distance measured horizontally at cementoenamel junction level from one border of the recession to another	Time Frame: 6 months after surgery
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
Thickness of keratinized tissue (GT	Thickness of the gingiva measured 2 mm apical to the gingival margin	Time Frame: 6 months after surgery
Average recession coverage (ARC)	The percentage of covered recession area	Time Frame: 6 months after surgery
Complete recession coverage	The percentage of sites with complete root coverage	Time Frame: 6 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probing pocket depth (PPD)	Distance from the gingival margin to the bottom of the gingival sulcus	Time Frame: 6 months after surgery
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
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
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 ]

Collaborators and Investigators

• Sponsor: Medical University of Warsaw
• Investigators: Principal Investigator: Bartłomiej Górski, PhD, Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2023
• Primary Completion (Estimated): May 30, 2024
• Study Completion (Estimated): May 30, 2024

Study Registration Dates

• First Submitted: April 10, 2024
• First Submitted That Met QC Criteria: April 10, 2024
• First Posted (Estimated): April 15, 2024

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: tunneling technique
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: Warsaw.06

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No