Clinical trial NCT02818855: Treatment of Multiple Gingival Recessions
Official title: Treatment of Multiple Gingival Recessions With Collagen Matrix Versus Subepithelial Connective Tissue Graft: A Non-inferiority Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gingival Recession
Keywords: Root coverage
Gingival recession
Plastic surgery
Connective tissue graft
Mucograft
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2016-06-30
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Gingival recession (GR) is frequently associated with deterioration in dental esthetics and dental hypersensitivity. Outcomes from recent systematic reviews have demonstrated that when the root is covered and the gain in the width of keratinized tissue (KT) is expected, the use of subepithelial connective tissue grafts (SCTGs) associated with coronally advanced flaps (CAF) appears to be more predictable, and may be considered the gold standard procedure. However, the SCTGs may increase patients' morbidity (e.g., pain). This occurs because of the need for a donor surgical area, which may increase the risk of surgical complications like bleeding, as well as increases post-operative discomfort and the period of the surgical procedure. Another biomaterial, a new collagen matrix (CM) has been used as a substitute for the SCTG. The use of CM was associated with a significant reduction in post-operative morbidity, less post-operative pain and discomfort in the patient, and more esthetic satisfaction.


Eligibility criteria: Inclusion Criteria:

* The patients will be included in the study if they fulfill the following inclusion criteria:

  1. a clinical diagnosis of multiple-recession type defects at maxillary canines and premolars with at least one GR ≥ 3mm in depth;
  2. areas of Miller's Class I or II GR;
  3. teeth without root abrasions or caries.

Exclusion Criteria: -

The exclusion criteria used will be as follows:

* patients allergic to collagen
* a history of smoking (within the previous 6 months)
* pregnancy or lactation
* a history of destructive periodontal disease or the formation of recurrent abscesses
* root caries at the site of recession
* previous surgical root coverage procedures
* systemic healing disorders (for example, acquired immunodeficiency syndrome \[AIDS\], diabetes mellitus or risk factors evaluated by a medical doctor)
* periodontal disease, or poor plaque control (full mouth plaque index \> 20%).

The exclusion criteria for teeth will be:

1. noncarious cervical lesions (erosion, abfraction etc.)
2. any type of previous cervical restoration
3. extrusion
4. giroversion
5. mobility
6. a prominent root surface.

Primary outcomes:
measure: Percentage of root coverage (RC)
timeFrame: 12-months
Secondary outcomes:
measure: Reductions in recession depth (RRD)
timeFrame: At the baseline, 3-month, 6-month and 12-months
measure: Complete root coverage of the gingival recessions (CRC)
timeFrame: At the baseline, 3-month, 6-month and 12-months
measure: Recession width (RW) at the cemento-enamel junction
timeFrame: At the baseline, 3-month, 6-month and 12-months
measure: Relative clinical attachment level (RCAL)
timeFrame: At the baseline, 3-month, 6-month and 12-months
measure: Probing depth (PD)
timeFrame: At the baseline, 3-month, 6-month and 12-months
measure: keratinized tissue width (KT)
timeFrame: At the baseline, 3-month, 6-month and 12-months
measure: Gain in thickness of gingival tissue (GT)
timeFrame: At the baseline, 3-month, 6-month and 12-months
Other outcomes:
measure: Subject esthetic satisfaction by participants
timeFrame: 1, 3, 6 months and after 12 months
measure: Subjective symptoms of pain and discomfort by participants
timeFrame: At 1, 2, 3-week, 1 month, 3-month, 6-month and12-months.
measure: Esthetic questionnaire by experienced periodontist
timeFrame: 1, 2, 3-week, 1-month, 3-month, 6-month and 12-months after surgery
Locations:
city: São Paulo
country: Brazil
facility: University of São Paulo
Study officials:
affiliation: University of Sao Paulo
name: Giuseppe Romito, PhD
role: STUDY_CHAIR
References:
citation: Jepsen K, Jepsen S, Zucchelli G, Stefanini M, de Sanctis M, Baldini N, Greven B, Heinz B, Wennstrom J, Cassel B, Vignoletti F, Sanz M. Treatment of gingival recession defects with a coronally advanced flap and a xenogeneic collagen matrix: a multicenter randomized clinical trial. J Clin Periodontol. 2013 Jan;40(1):82-9. doi: 10.1111/jcpe.12019. Epub 2012 Oct 10.
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: Sanz M, Lorenzo R, Aranda JJ, Martin C, Orsini M. Clinical evaluation of a new collagen matrix (Mucograft prototype) to enhance the width of keratinized tissue in patients with fixed prosthetic restorations: a randomized prospective clinical trial. J Clin Periodontol. 2009 Oct;36(10):868-76. doi: 10.1111/j.1600-051X.2009.01460.x. Epub 2009 Aug 12.