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

NCT06366022 | Completed Results DMC

• 1 other identifier: Warsaw.06
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gingival Recession

Keywords

tunneling technique

Outcome Measures

Primary Outcomes (1)

• Percent Change in Gingival Recession (Mean Root Coverage, MRC)

  Mean root coverage (MRC) was calculated as the percent change in gingival recession height from baseline to 6 months using the formula: (GR0 - GR6) / GR0 × 100%. * GR-gingival recession height: distance between the cementoenamel junction (CEJ) and the gingival margin at the mid-buccal side * GR0- before surgery * GR6- 6 months after surgery

  Baseline and 6 months after surgery

Secondary Outcomes (1)

• GR Change (Gingival Recession Height Change) GT Change (Gingival Thickness) KTW Change (Keratinized Tissue Width)

  6 months after surgery

Other Outcomes (1)

• Root Coverage Esthetic Score (RES)

  6 months after surgery

Study Arms (2)

The tunnel technique for root coverage with CTG with outer side of the graft

ACTIVE COMPARATOR

Procedure: 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 outer side into the tunnel and stabilized with absorbable suspensory sutures. The buccal flap is advanced coronally and stabilized with non-absorbable suspensory sutures. 21 participants were enrolled into the study, as it was designed to be a split mouth study

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

The tunnel technique for root coverage with CTG with inner side of the graft

EXPERIMENTAL

Procedure: 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 outer side into the tunnel and stabilized with absorbable suspensory sutures. The buccal flap is advanced coronally and stabilized with non-absorbable suspensory sutures. 21 participants were enrolled into the study, as it was designed to be a split mouth study.

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

Interventions

The tunnel technique for root coverage with CTG with inner side of the graft PROCEDURE

Tunnel technique for root coverage with a subepithelial connective tissue graft (CTG). A split-thickness mucogingival tunnel will be prepared without vertical releasing incisions. The CTG will be inserted into the tunnel and positioned so that the inner (deep) side of the graft faces the inner surface of the flap (standardized graft orientation). The graft will be stabilized with sutures, and the flap will be coronally advanced to completely cover the graft.

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 PROCEDURE

Tunnel technique for root coverage with a subepithelial connective tissue graft (CTG). A split-thickness mucogingival tunnel will be prepared without vertical releasing incisions. The CTG will be inserted into the tunnel and positioned so that the outer side of the graft faces the inner surface of the flap. The graft will be stabilized with sutures, and the flap will be coronally advanced to completely cover the graft.

The tunnel technique for root coverage with CTG with outer side of the graft

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age ≥ 18 years
• Bilateral multiple gingival recessions in homologous teeth in the same arch.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw

Warsaw, MAzowsze, 00-246, Poland

Location

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: dr Bartłomiej Górski
• Organization: Department of Periodontology and Oral Mucosa Diseases of Medical University of Warsaw

sluzowki@wum.edu.pl

(22)2701616

Study Officials

• Bartłomiej Górski, PhD

  Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 15, 2024
• Study Start: May 30, 2024
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2025
• Last Updated: May 14, 2026
• Results First Posted: May 14, 2026

Record last verified: 2025-11

Locations

PL (1)