Clinical trial NCT03207984: Comparison Between Connective Graft and Xenogeneic Matrix, in Patients With Multiple Gingival Recessions
Official title: Xenogeneic Collagen Matrix and Connective Tissue Graft Comparison for Multiple Gingival Recessions in Esthetic Areas: A Non-inferiority Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession, Generalized
Keywords: Gingival Recession
Collagen Matrix
Periodontics
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Geistlich Pharma AG
First posted: 2017-07-05
Enrollment: 37
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Subepithelial connective tissue graft (SCTG) is considered the gold standard for root coverage treatment. However, it is associated with postoperative morbidity, limited amount of donor tissue, and longer surgical time. Thus, the search for a tissue substitute for SCTG is increasing. Currently, one of the possible autogenous soft tissue substitutes found in the market is the Mucograft® xenogeneic matrix (CM). The results with the use of MC are very promising, both for root coverage as well as for the gain of keratinized tissue. The present study consists of a parallel randomized clinical trial to compare SCTG (control group) and CM (test group) in the treatment of Miller's class I and II gingival recessions, multiple in aesthetic areas (upper central incisors, Lateral and canine).

Detailed description: Obtaining an aesthetic smile is one of the main reasons for the patient's demand for dental treatment, especially when it comes to gingival recession. However, there is a lack of evidence in the literature explaining the most appropriate type of treatment for multiple recessions in aesthetic areas. For unitary gingival recessions, the subepithelial connective tissue graft (SCTG) is considered the gold standard because it presents greater predictability for root coverage. However, it is associated with postoperative morbidity, limited amount of donor tissue, and longer surgical time. Thus, the search for a tissue substitute for SCTG is increasing. Currently, one of the possible autogenous soft tissue substitutes found in the market is the Mucograft® xenogeneic matrix (CM). The results with the use of CM are very promising, both for root coverage as well as for the gain of keratinized mucosa. The present study will consist of a double-blind parallel randomized clinical trial to compare SCTG (control group) and CM (test group) in the treatment of Miller's class I and II gingival recessions, multiple in aesthetic areas (central incisors, Lateral, upper canine). All measurements will be evaluated initially and in the periods of 3, 6, and 12 months after the surgical procedure.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of multiple gingival recessions ≥ 2 mm, only in aesthetic areas (upper central and lateral incisive, and canine);
* Miller class I and II gingival recession areas
* Non-abrasive, erosive, or carious root surfaces
* Unrotated, non-extruded, and non-movable teeth
* Systemically healthy patients without contraindication to periodontal surgical procedures

Exclusion Criteria:

* Smokers
* Pregnant women and infants
* Patients with a history of periodontal disease or recurrent abscess formation
* Patients previously submitted to surgical procedures for root coverage
* Patients taking anti-convulsant drugs
* Antihypertensives, contraceptives or immunosuppressors
* Patients with low oral hygiene (plaque and bleeding index over 20%)

Primary outcomes:
measure: Gingival recession depth (GRD)
timeFrame: one year
Secondary outcomes:
measure: Keratinized mucosa width
timeFrame: year
measure: Dentin hypersensitivity
timeFrame: year
Other outcomes:
measure: Complete root coverage
timeFrame: year
measure: Probing Depth (PD)
timeFrame: year
measure: Clinical attachment level loss (CAL)
timeFrame: year
measure: Soft tissue thickness (STT)
timeFrame: year
Locations:
city: Bauru
country: Brazil
facility: Raphaella C Michel
state: SP
Study officials:
affiliation: University of São Paulo, Bauru School of Dentistry
name: Raphaella C Michel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McGuire MK, Scheyer ET. Xenogeneic collagen matrix with coronally advanced flap compared to connective tissue with coronally advanced flap for the treatment of dehiscence-type recession defects. J Periodontol. 2010 Aug;81(8):1108-17. doi: 10.1902/jop.2010.090698.
citation: Cardaropoli D, Tamagnone L, Roffredo A, Gaveglio L. Treatment of gingival recession defects using coronally advanced flap with a porcine collagen matrix compared to coronally advanced flap with connective tissue graft: a randomized controlled clinical trial. J Periodontol. 2012 Mar;83(3):321-8. doi: 10.1902/jop.2011.110215. Epub 2011 Jul 1.