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

NCT ID: NCT06366022

Last Updated: 2024-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-30

Study Completion Date

2024-05-30

Brief Summary

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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.

Detailed Description

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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

Conditions

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Gingival Recession

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

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

Interventions

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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

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Warsaw

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bartłomiej Górski, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Warsaw, MAzowsze, Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Nela Molga-Chlipała

Role: CONTACT

48604286899

Bartłomiej Górski, PhD

Role: CONTACT

0048221166431

Facility Contacts

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Bartłomiej Górski, PhD

Role: primary

48225022099

Other Identifiers

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Warsaw.06

Identifier Type: -

Identifier Source: org_study_id

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