Clinical trial NCT03619096: Two Different Surgical Techniques for the Treatment of Multiple Gingival Recessions With Porcine Collagen Matrix
Official title: Clinical Comparison Between Two Surgical Techniques for the Treatment of Multiple Gingival Recessions With Porcine Collagen Matrix
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gingival Recession
Xenograft Model
Gingival Recession, Generalized
Keywords: Gingival recession
porcine collagen matrix
multiple gingival recessions
tunnel technique
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2018-08-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Split Mouth clinical trial, comparing two different techniques. One side, the tunnel technique will be performed and on the other side, extended flap will be performed. Both surgical techniques will use Porcine Collagen Matrix.
Primary purpose: TREATMENT

Brief summary: The gold standard for gingival recession treatment is the coronal repositioning of the flap associated with the subepithelial connective tissue graft. The porcine collagen matrix (PCR) has been used as a substitute for subepithelial connective tissue graft in periodontal plastic surgery and has achieved similar results. The PCR use has the advantage of avoiding possible pre and postoperative complications , as well as overcome the limitations presented by autograft . The different surgical techniques used for root coverage seek predictability and success . For this, besides the type of incision placements flap and graft are the most important because the healing benefits and outcome .

The aim of this study is to compare two surgical techniques for root coverage and evaluate which one provides better clinical outcomes and less morbidity . 20 adults , nonsmoking patients , showing multiple bilateral gingival recessions , class I or II Miller located in canine, first and second premolars are selected. Both techniques use the PCR as a graft . However, in one Quadrant partial flap will be held together with relaxing incisions through an intrasulcular incision, PCR will be positioned 1 mm apical to the cementoenamel junction (CEJ) and the flap will be positioned 1 mm coronal CEJ. In the opposite quadrant periosteal envelope that does not use relaxing incisions, avoiding any scars, will be performed with the PCR. The clinical parameters (gingival recession height and width, keratinized tissue thickness and width) will be evaluated 2 weeks after basic periodontal therapy and after 6 and 12 months to surgical procedures..


Eligibility criteria: Inclusion Criteria:

-bilateral multiple gingival recession type Miller class I or II with at least one tooth with 3 mm of gingival recession height

Exclusion Criteria:

* diabetics
* pregnant women
* chronic use of medication
* periodontitis
* smokers

Primary outcomes:
measure: Root coverage (milimeters)
timeFrame: baseline, 6 and 12 motnhs
Secondary outcomes:
measure: Keratinized tissue (milimeters)
timeFrame: baseline, 6 and 12 months
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: Marilia Bianchini Lemos Reis
state: São Paulo
Study officials:
affiliation: University of Sao Paulo
name: Arthur Belem Novaes JR
role: PRINCIPAL_INVESTIGATOR
References: