Treatment of Multiple Gingival Recessions

Gingival Recession Clinical Trial

— 3DMUCO  

Official title:

Treatment of Multiple Gingival Recessions With Collagen Matrix Versus Subepithelial Connective Tissue Graft: A Non-inferiority Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02818855
• Other study ID #: 3DMUCO
• Status: Completed
• Phase: Phase 4
• First received: August 20, 2013
• Last updated: January 31, 2018
• Start date: March 2014
• Est. completion date: April 2016

Study information

• Verified date: January 2018
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gingival Recession

Intervention

Procedure:
• Coronally advanced flap (CAF)
The test group will be treated by means of the association of Collagen Matrix + Coronally Advanced Flap. As treatment, the control group will receive the association of a subepithelial Conjunctive Tissue Graft + Coronally Advanced Flap. The aim of both procedures will be to obtain root coverage. All these procedures will be performed in a standardized manner.

Drug:
• Collagen Matrix
A new collagen membrane

Procedure:
• Subepithelial connective tissue graft
Connective tissue graft

Locations

Country	Name	City	State
Brazil	University of São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

Jepsen K, Jepsen S, Zucchelli G, Stefanini M, de Sanctis M, Baldini N, Greven B, Heinz B, Wennström J, Cassel B, Vignoletti F, Sanz M. Treatment of gingival recession defects with a coronally advanced flap and a xenogeneic collagen matrix: a multicenter r — View 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 — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Subject esthetic satisfaction by participants	The participants will be invited to reply to a questionnaire on subject esthetic satisfaction with the surgical results (from dissatisfied to very satisfied) on a scale of 1-5, as well as after 1, 3, 6 months and after 12 months.	1, 3, 6 months and after 12 months
Other	Subjective symptoms of pain and discomfort by participants	Subjective symptoms of pain and discomfort (without pain and with a great deal of pain) will be evaluated with 10 cm (0-10) visual analog scales (VAS) at 1, 2, 3-week, 1 month, 3-month, 6-month and12-months.	At 1, 2, 3-week, 1 month, 3-month, 6-month and12-months.
Other	Esthetic questionnaire by experienced periodontist	One experienced periodontist will be invited to observe the initial photographs and those of the clinical results obtained during the entire healing process and asked to respond to an esthetic questionnaire (from dissatisfied to very satisfied) on a scale of 1 to 5 points after 1, 2, 3-week, 1-month, 3-month, 6-month and 12-months.12 All this examinations also will be performed in the clinic.	1, 2, 3-week, 1-month, 3-month, 6-month and 12-months after surgery
Primary	Percentage of root coverage (RC)	The primary clinical outcome will be percentage of root coverage (RC) at 12 months	12-months
Secondary	Reductions in recession depth (RRD)	Measured from the cementum-enamel junction (CEJ) up to the highest point of the gingival margin	At the baseline, 3-month, 6-month and 12-months
Secondary	Complete root coverage of the gingival recessions (CRC)		At the baseline, 3-month, 6-month and 12-months
Secondary	Recession width (RW) at the cemento-enamel junction		At the baseline, 3-month, 6-month and 12-months
Secondary	Relative clinical attachment level (RCAL)	Measured from a fixed point (stent) prepared on the acrylic guide up to the base of the gingival sulcus.	At the baseline, 3-month, 6-month and 12-months
Secondary	Probing depth (PD)	Calculated as RCAL- PD;	At the baseline, 3-month, 6-month and 12-months
Secondary	keratinized tissue width (KT)	From the free gingival margin to the mucogingival junction.	At the baseline, 3-month, 6-month and 12-months
Secondary	Gain in thickness of gingival tissue (GT)	With an injection needle and a silicon marker, 2mm below the gingival margin.	At the baseline, 3-month, 6-month and 12-months