The Use of Mucograft® to Treat Gingival Recession

Gingival Recession Clinical Trial

Official title:

Clinical Applications of 3D Collagen Matrix (Mucograft®) in the Management of Gingival Recession: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02986191
• Other study ID #: UDDS-Perio-01-2016
• Status: Completed
• Phase: N/A
• First received: November 29, 2016
• Last updated: February 3, 2018
• Start date: August 2016
• Est. completion date: December 20, 2017

Study information

• Verified date: February 2018
• Source: Damascus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Twenty patients with gingival recession will be enrolled in this trial. Gingival recession will be treated in one side by applying Mucograft® with coronally advanced flap (CAF) while on the opposite side a connective tissue graft (from the palate) will be applied with a CAF.

Patients will be followed for 3 and 6 months by measuring the clinical indexes and statistical analyses will be performed to compare the results and to assess the success of Mucograft®.

Description:

Many surgical techniques have used to treat gingival recession such aas repositioned flaps, autologous soft tissue grafts (connective tissue graft or free gingival grafts) or allografts like acellular dermal which can be used as substitutes for palatal donor tissue. Mucograft® (3D collagen matrix) is also an allograft from porcine origin and is designed for soft tissue regeneration and considered the ideal solution to autogenous soft tissue grafts and it provides an ideal matrix for blood vessel and soft tissue ingrowth.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 20, 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• Presence of Type I or II (Miller Classification) of gingival recession

Exclusion Criteria:

• Smoking

• Pregnancy or lactating

• Presence of any systematic diseases can affect the periodontal surgery.

• Subjects with significant moderate to severe periodontal disease.

• Patients under orthodontic treatment

• Presence of restorative materials (e.g. crown)

• Effectiveness of frenum

• Subjects have failed to maintain good plaque control.

• Subjects having previous surgical treatment for covering the recession in the chosen area.

Related Conditions & MeSH terms

• Gingival Recession

Intervention

Procedure:
• Mucograft
This method of grafting will be used to treat the gingival recession using coronally advanced flaps.
• Connective Tissue Graft
This will be used in the traditional manner to correct gingival recession

Locations

Country	Name	City	State
Syrian Arab Republic	Department of Periodontics, University of Damascus Dental School	Damascus

Sponsors (1)

Lead Sponsor	Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (7)

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. — View Citation

Herford AS, Akin L, Cicciu M, Maiorana C, Boyne PJ. Use of a porcine collagen matrix as an alternative to autogenous tissue for grafting oral soft tissue defects. J Oral Maxillofac Surg. 2010 Jul;68(7):1463-70. doi: 10.1016/j.joms.2010.02.054. Epub 2010 Apr 22. — View Citation

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 randomized clinical trial. J Clin Periodontol. 2013 Jan;40(1):82-9. doi: 10.1111/jcpe.12019. Epub 2012 Oct 10. — View Citation

McGuire MK, Scheyer ET. Long-Term Results Comparing Xenogeneic Collagen Matrix and Autogenous Connective Tissue Grafts With Coronally Advanced Flaps for Treatment of Dehiscence-Type Recession Defects. J Periodontol. 2016 Mar;87(3):221-7. doi: 10.1902/jop.2015.150386. Epub 2015 Oct 15. — View Citation

McGuire MK, Scheyer ET. Randomized, controlled clinical trial to evaluate a xenogeneic collagen matrix as an alternative to free gingival grafting for oral soft tissue augmentation. J Periodontol. 2014 Oct;85(10):1333-41. doi: 10.1902/jop.2014.130692. Epub 2014 Mar 5. — View Citation

Nevins M, Nevins ML, Kim SW, Schupbach P, Kim DM. The use of mucograft collagen matrix to augment the zone of keratinized tissue around teeth: a pilot study. Int J Periodontics Restorative Dent. 2011 Jul-Aug;31(4):367-73. — View Citation

Rocchietta I, Schupbach P, Ghezzi C, Maschera E, Simion M. Soft tissue integration of a porcine collagen membrane: an experimental study in pigs. Int J Periodontics Restorative Dent. 2012 Feb;32(1):e34-40. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Clinical Attachment Level Index	Clinical Attachment Level is dependent on measuring the pocket depth as well as the amount of gingival recession using specific tools. The measurement is going to be recorded in millimeters.	Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively
Secondary	Change in Probing Depth	Probing depth is going to be measuring using a specific tool (UNC-15 probe).	Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively
Secondary	Change in Gingival Recession	Gingival recession is measured from the cemento-enamel junction to the gingival margin of the recessed tissues.	Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively
Secondary	Change in Gingival Biotype	Gingival biotype is assessed by an endodontic file which used to determine the thickness of the gingival tissues (i.e. thick or thin).	Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively
Secondary	Change in Root Coverage Index	The amount of root exposure will be measured and compared to the total length of the root	Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively
Secondary	Change in Resistance to Muscular Pull	The cheeks or lips are going to be retracted by hand or by a mirror in order to see the movement of the free gingival tissues. The movement will be esitmated in millimeters.	Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively
Secondary	Change in Color Match Index		Measurements will be done at :(1) one hour before applying the graft, (2) at three months exactly post-operatively and (3) at six months exactly post-operatively
Secondary	Shrinkage index at three months		Measurements will be done at two time points to calculate the amount of shrinkage :(1) at one hour before applying the graft, (2) at three months exactly post-operatively.
Secondary	Shrinkage index at six months		Measurements will be done at two time points to calculate the amount of shrinkage :(1) at one hour before applying the graft, (2) at six months exactly post-operatively.