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MCAT With HA and sCTG Compared With sCTG Alone for Treatment of Multiple Gingival Recession: Clinical Trial

Primary Purpose

Gingival Recession

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
The tunnel technique for root coverage with CTG without Cross-linked Hyaluronic Acid
The tunnel technique for root coverage with CTG andCross-linked Hyaluronic Acid
Sponsored by
Medical University of Warsaw
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession focused on measuring connective tissue graft, tunneling flap procedure, hyaluronic acid

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

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

Sites / Locations

  • Department of Periodontology and Oral Mucosa Diseases, Medical University of WarsawRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Modified Coronally Advanced Tunnel With Connective Tissue Graft

MCAT With Cross-linked Hyaluronic Acid in Addition to CTG

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 6, 2021
Last Updated
October 11, 2021
Sponsor
Medical University of Warsaw
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1. Study Identification

Unique Protocol Identification Number
NCT05045586
Brief Title
MCAT With HA and sCTG Compared With sCTG Alone for Treatment of Multiple Gingival Recession: Clinical Trial
Official Title
Modified Coronally Advanced Tunnel With Cross-linked Hyaluronic Acid in Addition to Connective Tissue Graft Compared With Subepithelial Connective Tissue Graft Alone for Treatment of Multiple Gingival Recession: Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 15, 2021 (Actual)
Primary Completion Date
September 15, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Warsaw

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The treatment of multiple adjacent recession appears to be challenging for the clinician due to large surgical field, variation in teeth position in the dental arch (prominent roots), variation in recession size, thin phenotype and insufficient keratinized tissue in many teeth. Surgical treatment of all multiple recession in one dental arch during one session appears to be optimum. Surgical treatment time is longer, however patient doesn't need to undergo multiple surgeries, pharmacological therapies and postsurgical instructions. Esthetic concern seems to be one of the most common complaints from patients. Among utilized surgical techniques tunneling flap procedures using connective tissue grafts (CTG) with or without biologics such as an enamel matrix derivative (EMD) or hyaluronic acid (HA) provided the most successful outcomes for the treatment. Cross-linked hyaluronic acid can be used in conjunction with subepithelial palatal connective tissue grafts to improve postsurgical results and improving healing process. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession
Keywords
connective tissue graft, tunneling flap procedure, hyaluronic acid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Modified Coronally Advanced Tunnel With Connective Tissue Graft
Arm Type
Experimental
Arm Description
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.
Arm Title
MCAT With Cross-linked Hyaluronic Acid in Addition to CTG
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
The tunnel technique for root coverage with CTG without Cross-linked Hyaluronic Acid
Intervention Description
The tunnel technique for root coverage with CTG without Cross-linked Hyaluronic Acid
Intervention Type
Device
Intervention Name(s)
The tunnel technique for root coverage with CTG andCross-linked Hyaluronic Acid
Intervention Description
The tunnel technique for root coverage with CTG andCross-linked Hyaluronic Acid
Primary Outcome Measure Information:
Title
Periodontal parameters measured before surgery.
Description
Probing pocket depth (PPD) MEASURED IN MILIMETERS: distance from the gingival margin to the bottom of the gingival sulcus Clinical attachment level (CAL) MEASURED IN MILIMETERS: distance from the cementoenamel junction to the bottom of the gingival sulcus Recession height (RH) MEASURED IN MILIMETERS: distance from the cementoenamel junction to the gingival margin Width of keratinized tissue (WKT) MEASURED IN MILIMETERS: distance between the most apical point of the gingival margin and the mucogingival junction Gingival thickness (GT) MEASURED IN MILIMETERS: thickness of the gingiva measured 2-3 mm apical to the gingival margin
Time Frame
1-7 days before surgery
Secondary Outcome Measure Information:
Title
Periodontal parameters measured after surgery.
Description
Probing pocket depth (PPD): distance from the gingival margin to the bottom of the gingival sulcus Clinical attachment level (CAL): distance from the cementoenamel junction to the bottom of the gingival sulcus Recession height (RH): distance from the cementoenamel junction to the gingival margin Width of keratinized tissue (WKT): distance between the most apical point of the gingival margin and the mucogingival junction Gingival thickness (GT): thickness of the gingiva measured 2-3 mm apical to the gingival margin ALL ABOVE PARAMETERS ARE MEASURED IN MILIMETERS
Time Frame
12 months after surgery
Other Pre-specified Outcome Measures:
Title
Patient-reported outcomes based on VAS scales
Description
Questionnaires: Scale 1: Pain after surgery (during recent 2 weeks) from 0 (no pain) to 10 (very big pain)
Time Frame
2 weeks after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years Bilateral multiple gingival recessions in homologous teeth 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Beata Wyrębek, PhD
Phone
+48692013589
Email
beatawyrebek@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Bartłomiej Górski, PhD
Phone
00 48 22 116 64 31
Email
gorskibartlomiej04@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Batlomiej Górski, PhD
Organizational Affiliation
Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw
City
Warsaw
State/Province
Mazowsze
ZIP/Postal Code
00-246
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Batlomiej Gorski, DDS, PhD
Phone
+48 22 502 20 99

12. IPD Sharing Statement

Learn more about this trial

MCAT With HA and sCTG Compared With sCTG Alone for Treatment of Multiple Gingival Recession: Clinical Trial

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