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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05045586
Enrollment
15
Registered
2021-09-16
Start date
2021-09-15
Completion date
2022-12-01
Last updated
2021-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingival Recession

Keywords

connective tissue graft, tunneling flap procedure, hyaluronic acid

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.

Interventions

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

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

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

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

Sponsors

Medical University of Warsaw
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Periodontal parameters measured before surgery.1-7 days before surgery1. 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

Secondary

MeasureTime frameDescription
Periodontal parameters measured after surgery.12 months after surgery1. Probing pocket depth (PPD): distance from the gingival margin to the bottom of the gingival sulcus 2. Clinical attachment level (CAL): distance from the cementoenamel junction to the bottom of the gingival sulcus 3. Recession height (RH): distance from the cementoenamel junction to the gingival margin 4. Width of keratinized tissue (WKT): distance between the most apical point of the gingival margin and the mucogingival junction 5. Gingival thickness (GT): thickness of the gingiva measured 2-3 mm apical to the gingival margin ALL ABOVE PARAMETERS ARE MEASURED IN MILIMETERS

Other

MeasureTime frameDescription
Patient-reported outcomes based on VAS scales2 weeks after surgeryQuestionnaires: Scale 1: Pain after surgery (during recent 2 weeks) from 0 (no pain) to 10 (very big pain)

Countries

Poland

Contacts

Primary ContactBeata Wyrębek, PhD
beatawyrebek@gmail.com+48692013589
Backup ContactBartłomiej Górski, PhD
gorskibartlomiej04@gmail.com00 48 22 116 64 31

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026