K06.0
Conditions
Interventions
Group 1: All patients belong to the Arm 1 and each of them obtains a Collagen Matrix 10808 in combination with the coronally advanced flap (CAF) during the surgical Intervention in order to obtain sof
Sponsors
Geistlich Pharma AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Signed informed consent with given ample time 2. Age 18 years or older 3. Recession defects are Miller Class I-II at incisors, canines or premolars 4. Recession size of > 3mm 5. Presence of at least 1 mm keratinized tissue around the target tooth 6. Full-Mouth Plaque score < 25% (O'Leary, Drake et al. 1972) 7. Patients with healthy or effectually treated periodontal conditions
Exclusion criteria
Exclusion criteria: 1.General contraindications for dental and/or surgical treatments 2.Concurrent or previous immunosuppressant, bisphosphonate or high dose corticosteroid therapy 3.Inflammatory and autoimmune disease of oral cavity 4.History of myeloma, respiratory tract cancer, breast cancer, prostate cancer or kidney cancer requiring chemotherapy or radiotherapy within the past five years 5.Radiotherapy of head area 6.Disease or condition affecting connective tissue metabolism (e.g. disease of arteries in the operating zone, bone metabolic diseases, alcohol abuse, treatment with anticoagulants) 7.Any systemic diseases that affect bone metabolism (e.g thyroid dysfunction, autoimmune disease) 8.Untreated acute periodontal disease 9.Smokers (zero cigarettes allowed per day) 10.Diabetes 11.Pregnant or lactating women 12.Women of child bearing age, not using a highly effective method of birth control 13.Allergy to collagen 14.Participation in an investigational device, - drug or biologic study within the last 24 weeks prior to the study start
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is the safety of Collagen Matrix 10808 in the indication of single tooth gingival recession coverage. Safety will be assessed based on soft tissue wound healing events that could be considered related to the device as listed below. -Wound closure -Inflammation of the tissues in the surgical area -Flap necrosis -Dehiscences -Swelling of the soft tissues around surgical area -Bleeding of the wound -Presence of abscess/pus/fistula -Sensibility disorders -Any other reaction of the soft tissue in the area of the treatment All Parameters will be assessed from Visit 3 onwards (Day 1, Day 3, Day 7, Day 14, Day 30, Day 90, Day 180). | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety • Assessment of AEs • Daily Ibuprofen consumption between day 0 and day 7 • Evaluation of pain using a VAS score at day 1, 3 and 7 Usability • The appropriate surgical procedure and clinical handling will be assessed and defined by the evaluation of a standardized questionnaire completed by the surgeon. Performance • Mean root coverage (day 0, 90, 180) • Recession width (day 0, 90, 180) • Percentage of complete root coverage (day 0, 180) • Thickness of soft tissue over the root measured by transmucosal needle probing (day 0, 180) • Thickness of soft tissue over the root measured by Ultrasonic device (PIROP) (day 0, 14, 30, 90, 180) • Periodontal tissue health status: KT width, PD, CAL, BOP, PI (day 0, 180) • Evaluation of the esthetic appearance by the investigator (day 180) | — |
Countries
Italy
Contacts
Public ContactGiovanni Zucchelli
University of BolognaDepartment of Odontostomatology
Outcome results
None listed