NCT05045586

Brief Summary

Microsurgical tunneling flap procedures using connective tissue grafts (CTG) are predictable for treating teeth with gingival recessions. Cross-linked hyaluronic acid can be used in conjunction with subepithelial palatal connective tissue grafts to improve postsurgical results. The aim of this study is to evaluate clinically the use of tunnel technique with CTG and cross-linked hyaluronic acid in addition to CTG alone for the treatment of multiple gingival recessions.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2021

Completed
9 days until next milestone

Study Start

First participant enrolled

September 15, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 16, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

October 12, 2021

Status Verified

June 1, 2021

Enrollment Period

1 year

First QC Date

September 6, 2021

Last Update Submit

October 11, 2021

Conditions

Gingival Recession

Keywords

connective tissue grafttunneling flap procedurehyaluronic acid

Outcome Measures

Primary Outcomes (1)

  • Periodontal parameters measured before surgery.

    1. Probing pocket depth (PPD) MEASURED IN MILIMETERS: distance from the gingival margin to the bottom of the gingival sulcus 2. Clinical attachment level (CAL) MEASURED IN MILIMETERS: distance from the cementoenamel junction to the bottom of the gingival sulcus 3. Recession height (RH) MEASURED IN MILIMETERS: distance from the cementoenamel junction to the gingival margin 4. Width of keratinized tissue (WKT) MEASURED IN MILIMETERS: distance between the most apical point of the gingival margin and the mucogingival junction 5. Gingival thickness (GT) MEASURED IN MILIMETERS: thickness of the gingiva measured 2-3 mm apical to the gingival margin

    1-7 days before surgery

Secondary Outcomes (1)

  • Periodontal parameters measured after surgery.

    12 months after surgery

Other Outcomes (1)

  • Patient-reported outcomes based on VAS scales

    2 weeks after surgery

Study Arms (2)

Modified Coronally Advanced Tunnel With Connective Tissue Graft

EXPERIMENTAL

Procedure: A modified microsurgical tunnel technique by Zuhr et al. (2007). Initial sulcular incisions with a microsurgical blade are followed by a split-thickness buccal flap preparations using the tunneling knives. The 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 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 without Cross-linked Hyaluronic Acid

MCAT With Cross-linked Hyaluronic Acid in Addition to CTG

ACTIVE COMPARATOR

Procedure: A modified microsurgical tunnel technique by Zuhr et al. (2007). Initial sulcular incisions with a microsurgical blade are followed by a split-thickness buccal flap preparations using the tunneling knives. The 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 root surfaces are applied with cross-linked hyaluronic acid. The graft is inserted 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 andCross-linked Hyaluronic Acid

Interventions

The tunnel technique for root coverage with CTG without Cross-linked Hyaluronic AcidDEVICE

The tunnel technique for root coverage with CTG without Cross-linked Hyaluronic Acid

Modified Coronally Advanced Tunnel With Connective Tissue Graft
The tunnel technique for root coverage with CTG andCross-linked Hyaluronic AcidDEVICE

The tunnel technique for root coverage with CTG andCross-linked Hyaluronic Acid

MCAT With Cross-linked Hyaluronic Acid in Addition to CTG

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age ≥ 18 years
  • Bilateral multiple gingival recessions in homologous teeth

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Warsaw, Mazowsze, 00-246, Poland

RECRUITING

Related Publications (2)

  • Gorski B, Skierska IM, Gelemanovic A, Roguljic M, Bozic D. Multiple Recessions Coverage Using the Modified Tunnel Technique and Connective Tissue Graft with or Without Cross-Linked Hyaluronic Acid: 2-Year Outcomes of RCT. J Funct Biomater. 2025 Mar 4;16(3):87. doi: 10.3390/jfb16030087.

    PMID: 40137366DERIVED

  • Gorski B, Skierska IM, Nijakowski K, Brodzikowska A. Tunnel Technique and Subepithelial Connective Tissue Graft, With or Without Cross-Linked Hyaluronic Acid, in the Treatment of Multiple Gingival Recessions: Prognostic Parameters for Clinical Treatment Outcomes of Randomized Controlled Trial. J Clin Med. 2024 Nov 10;13(22):6758. doi: 10.3390/jcm13226758.

    PMID: 39597902DERIVED

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Officials

  • Batlomiej Górski, PhD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Beata Wyrębek, PhD

CONTACT

+48692013589beatawyrebek@gmail.com

Bartłomiej Górski, PhD

CONTACT

00 48 22 116 64 31gorskibartlomiej04@gmail.com

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

September 6, 2021

First Posted

September 16, 2021

Study Start

September 15, 2021

Primary Completion

September 15, 2022

Study Completion

December 1, 2022

Last Updated

October 12, 2021

Record last verified: 2021-06

Locations

PL(1)