Clinical trial NCT02986191: The Use of Mucograft® to Treat Gingival Recession
Official title: Clinical Applications of 3D Collagen Matrix (Mucograft®) in the Management of Gingival Recession: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Keywords: gingival graft
free gingival graft
coronally advanced flap
reduced keratinized gingiva
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2016-12-08
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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®.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in the Clinical Attachment Level Index
timeFrame: 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 outcomes:
measure: Change in Probing Depth
timeFrame: 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
measure: Change in Gingival Recession
timeFrame: 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
measure: Change in Gingival Biotype
timeFrame: 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
measure: Change in Root Coverage Index
timeFrame: 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
measure: Change in Resistance to Muscular Pull
timeFrame: 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
measure: Change in Color Match Index
timeFrame: 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
measure: Shrinkage index at three months
timeFrame: 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.
measure: Shrinkage index at six months
timeFrame: 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.
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Department of Periodontics, University of Damascus Dental School
Study officials:
affiliation: PhD Student in Periodontics, University of Damascus Dental School, Damascus, Syria
name: Haydar Barakat, DDS MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate Professor of Periodontics, Department of Peridontics, Univ. of Damascus Dental School
name: Suleiman Dayoub, DDS MSc PhD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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. 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.
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.