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Completed

NCT Number: NCT06366022

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Warsaw, MAzowsze, 00-246, Poland

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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.

Primary outcomes

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

    Time frame: Baseline and 6 months after surgery

    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

Secondary outcomes

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

    Time frame: 6 months after surgery

    The analyzed metrics were calculated as follows:

    GR change= GR0-GR6 (after 6 months); ) [millimetre] higher scores mean better outcome GT change = GT6-GT0 (after 6 months); [millimetre] higher scores mean better outcome KTW change = KTW6-KTW0 (after 6 months); [millimetre] higher scores mean better outcome

    • GR-gingival recession height: distance between the cementoenamel junction (CEJ) and the gingival margin at the mid-buccal side
    • GT- gingival thickness
    • KTW- distance between the gingival margin and the muco-gingival junction (MGJ)
    • 0- before surgery
    • 6- 6 months after surgery

Other outcomes

  1. Root Coverage Esthetic Score (RES)

    Time frame: 6 months after surgery

    RES:The following variables were assessed:

    • GM - assessment rule: 0 points- root coverage failure, 3 points- partial root coverage, 6 points- complete root coverage;
    • marginal tissue contour (MTC) - assessment rule: 0 points - irregular gingival margin, not in line with the CEJ, 1 point- scalloped gingival contour, in line with the CEJ;
    • soft tissue texture (STT) - assessment rule: 0 points - scar formation, 1 point- absence of scars;
    • MGJ - assessment rule: 0 points - MGJ not aligned with the MGJ of adjacent teeth, 1 point- MGJ aligned with the MGJ of adjacent teeth;
    • gingival color (GC) - assessment rule: 0 points- color does not match adjacent teeth, 1 point- color matches adjacent teeth The maximum score for RES was 10, the minimum 0. Higher scores mean better outcome.

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Apr 15, 2024
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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