Clinical trial NCT05045586: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Gingival Recession
Keywords: connective tissue graft
tunneling flap procedure
hyaluronic acid
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2021-09-16
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Periodontal parameters measured before surgery.
timeFrame: 1-7 days before surgery
Secondary outcomes:
measure: Periodontal parameters measured after surgery.
timeFrame: 12 months after surgery
Other outcomes:
measure: Patient-reported outcomes based on VAS scales
timeFrame: 2 weeks after surgery
Locations:
city: Warsaw
country: Poland
facility: Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw
state: Mazowsze
Study officials:
affiliation: Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw
name: Batlomiej Górski, PhD
role: PRINCIPAL_INVESTIGATOR
References: