Status:
COMPLETED
Adjunctive Benefit of a Xenogenic Collagen Matrix
Lead Sponsor:
Roberto Rotundo
Collaborating Sponsors:
Geistlich Pharma AG
Conditions:
Gingival Recession
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The present CONSORT-based randomized clinical trial is to assess the adjunctive benefit of a xenogenic collagen matrix in combination with a coronal advanced flap with respect to a coronal advanced fl...
Detailed Description
This is a single-centre, superiority, double blind clinical trial, with balanced randomisation and parallel two groups design. The 2 groups will be: 1. CAF combined with XCM; 2. CAF alone. The objec...
Eligibility Criteria
Inclusion
- The patient (male or female) must be 18 years or older
- Presence of gingival recessions in the upper jaw, involving teeth from central incisor to first molar
- Gingival recessions on at least 2 adjacent teeth with a minimal depth of 2mm and detectable cemento-enamel junction (CEJ) (abrasion step \<1mm)
- The patient is able to comply with the study-related procedures such as exercising good oral hygiene and attending all follow-up procedures
- Full Mouth Plaque (FMPS) and Bleeding (FMBS) Score \<20%
- The patient is able to fully understand the nature of the proposed surgery and is able to provide a signed informed consent
Exclusion
- Smoker patients
- Pregnant patients
- Patients affect by uncontrolled diabetes
- General contraindications for dental and/or surgical treatment are present
- History of malignancy, radiotherapy, or chemotherapy for malignancy within the past 5 years
- The patient is taking medications or having treatments which have an effect on mucosal healing in general (e.g. steroids, large doses of anti-inflammatory drugs, anticoagulation drugs)
- The patient has a disease, which affects connective tissue metabolism (e.g. collagenases)
- The patient is allergic to collagen
- The patient is an abuser of alcohol or drug
- Patients have participated in a clinical trial within the last six months
- Presence of untreated periodontitis
- Gingival recessions on molar teeth (excluding the first) or on malpositioned teeth
- Presence of abrasion ≥ 1 mm or cervical restoration, with non-detectable CEJ
Key Trial Info
Start Date :
November 28 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 17 2017
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03833765
Start Date
November 28 2012
End Date
July 17 2017
Last Update
February 12 2019
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