Gingival Recession
Conditions
Brief 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.
Interventions
DEVICEThe tunnel technique for root coverage with Emdogain
The tunnel technique for root coverage with Emdogain
DEVICEThe tunnel technique for root coverage without Emdogain
The tunnel technique for root coverage without Emdogain
Sponsors
Medical University of Warsaw
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
| Measure | Time frame | Description |
|---|---|---|
| Clinical attachment level (CAL) | 6 months after surgery | Distance from the cementoenamel junction to the bottom of the gingival sulcus |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recession height (RH) | 6 months after surgery | Distance from the cementoenamel junction to the gingival margin |
| Recession width (RW) | 6 months after surgery | Distance measured horizontally at cementoenamel junction level from one border of the recession to another |
| Width of keratinized tissue (WKT) | 6 months after surgery | Distance between the most apical point of the gingival margin and the mucogingival junction |
| Average recession coverage (ARC) | 6 months after surgery | The percentage of covered recession area |
| Complete recession coverage | 6 months after surgery | The percentage of sites with complete root coverage |
| Thickness of keratinized tissue (TKT) | 6 months after surgery | Thickness of the gingiva measured 2 mm apical to the gingival margin |
Other
| Measure | Time frame | Description |
|---|---|---|
| Post surgical pain and swelling | 1, 2, 4, 7 and 14 days after surgery | 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. |
| Patient's satisfaction with treatment | 6 months after surgery | 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. |
| Root coverage esthetic score (RES) | 6 months after surgery | A score including root coverage, marginal gingival tissue contour, mucogingival junction alignment, soft tissue texture and gingival colour according to Cairo et al. (1999) |
| Probing pocket depth (PPD) | 6 months after surgery | Distance from the gingival margin to the bottom of the gingival sulcus |
Countries
Poland
Contacts
Primary ContactTomasz Kaczynski, DDS
Outcome results
None listed