Tunnel Technique With Emdogain® in Addition to Connective Tissue Graft Compared With Connective Tissue Graft Alone for the Treatment of Gingival Recessions: a Randomized Clinical Trial.

Gingival Recession Clinical Trial

Official title:

Tunnel Technique With Emdogain® in Addition to Connective Tissue Graft Compared With Connective Tissue Graft Alone for the Treatment of Gingival (Periodontal?) Recessions: a Randomized Clinical Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03354104
• Other study ID #: WUM.PERIO.01
• Status: Recruiting
• Phase: N/A
• First received: November 8, 2017
• Last updated: January 22, 2018
• Start date: January 22, 2018
• Est. completion date: May 5, 2019

Study information

• Verified date: January 2018
• Source: Medical University of Warsaw
• Contact: Tomasz Kaczynski, DDS
• Phone: +48 22 502 20 99
• Email: t.kaczynski[@]me.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. Enamel matrix derivatives (EMD) can be used as an alternative to the aforementioned gold standard. The aim of this study is to evaluate clinically the use of tunnel technique with EMD applied group in addition to CTG and the same technique with CTG group for the treatment of multiple gingival recessions.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 5, 2019
• Est. primary completion date: January 5, 2019
• 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 Emdogain
The tunnel technique for root coverage with Emdogain
• The tunnel technique for root coverage without Emdogain
The tunnel technique for root coverage without Emdogain

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	Probing pocket depth (PPD)	Distance from the gingival margin to the bottom of the gingival sulcus	6 months after surgery
Other	Root coverage esthetic score (RES)	A score including root coverage, marginal gingival tissue contour, mucogingival junction alignment, soft tissue texture and gingival colour according to Cairo et al. (1999)	6 months after surgery
Other	Post surgical pain and swelling	Questionnaire about post surgical pain and swelling using a Visual Analog Scale with values 0 (no pain / swelling), 1, 2, 3, 4, 5(moderate pain/swelling), 6, 7, 8, 9, 10 (worst pain / swelling). Lower values represent lower post surgical discomfort and are considered better.	1, 2, 4, 7 and 14 days after surgery
Other	Patient's satisfaction with treatment	Questionnaire about patient's esthetic perception of gingiva and overall satisfaction using a Visual Analog Scale from 0 (dissatisfaction with esthetic outcome), 2, 3, 4, 5 (moderate satisfaction with easthetic outcome), 6, 7, 8, 9, 10 (best satisfaction with esthetic outcome). Higher values are considered better.	6 months after surgery
Primary	Clinical attachment level (CAL)	Distance from the cementoenamel junction to the bottom of the gingival sulcus	6 months after surgery
Secondary	Recession height (RH)	Distance from the cementoenamel junction to the gingival margin	6 months after surgery
Secondary	Recession width (RW)	Distance measured horizontally at cementoenamel junction level from one border of the recession to another	6 months after surgery
Secondary	Width of keratinized tissue (WKT)	Distance between the most apical point of the gingival margin and the mucogingival junction	6 months after surgery
Secondary	Thickness of keratinized tissue (TKT)	Thickness of the gingiva measured 2 mm apical to the gingival margin	6 months after surgery
Secondary	Average recession coverage (ARC)	The percentage of covered recession area	6 months after surgery
Secondary	Complete recession coverage	The percentage of sites with complete root coverage	6 months after surgery