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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05045586
• Other study ID #: WUM.Perio.03
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: June 2021
• Source: Medical University of Warsaw
• Contact: Beata Wyrebek, PhD
• Phone: +48692013589
• Email: beatawyrebek[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 1, 2022
• Est. primary completion date: September 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Gingival Recession

Intervention

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

Locations

Country	Name	City	State
Poland	Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw	Warsaw	Mazowsze

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient-reported outcomes based on VAS scales	Questionnaires: Scale 1: Pain after surgery (during recent 2 weeks) from 0 (no pain) to 10 (very big pain)	2 weeks after surgery
Primary	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	1-7 days before surgery
Secondary	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	12 months after surgery