Clinical and Histomorphometric Analysis of Collagen Matrix Versus Connective Tissue Graft in Mucogingival Surgery in Orthodontic Patients

Gingival Recession Clinical Trial

Official title:

Clinical and Histomorphometric Analysis of Collagen Matrix Versus Connective Tissue Graft in Mucogingival Surgery in Orthodontic Patients. A Randomized, Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03533933
• Other study ID #: MCP-2
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: June 1, 2022

Study information

• Verified date: July 2019
• Source: Basque Country University
• Contact: Elena Ruiz de Gopegui
• Phone: 0034649547011
• Email: helenruizdegopegui[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

There are some orthodontics treatments that perform risk movements ,and a bone dehiscence may be expected. In that cases mucogingival surgery , such as connective tissue grafts, is necessary prior to tooth movement.

The connective tissue graft in combination with coronal advanced flap is still considered the gold standard , although the use of porcine collagen matrix has obtained promising results for treatment of Miller class I and II recession defects.

Most of the studies report clinical results after a connective tissue graft and there is no evidence about the type of attachment obtained after the graft is performed, a few articles have shown histological results. But, as a rule , a histological study is only performed under exceptional circumstances such as a dental fracture, untreatable decay, tooth extraction for orthodontic reasons, or other reasons.

Most of the techniques results in the formation of a long junctional epithelium and connective tissue attachment with fibers parallel to the root surface. Animals studies have shown a shorter epithelium and a larger new cementum formation after the use of the collagen matrix.

Description:

The purpose of this study is to confirm that periodontal regeneration happens after mucogingival surgery The principal outcome is compare the millimeters of new attachment create after a connective tissue graft and after the use of a porcine collagen matrix in teeth that have to been extracted (because of the orthodontic planing treatment) after mucogingival surgery .

The secondary outcomes are:

1. length of new cementum (histometry results)

2. length of the junctional epithelium (histometry results)

3. length of connective tissue attachment (histometry results)

4. complete root coverage (clinical results)

5. width of keratinized tissue

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patient in orthodontic treatment ,who needs mucogingival surgery in both hemi arcade and later the tooth adjacent to the graft should be extracted because of the orthodontic planing treatment .

• The patient must be 18 years or older

• Patient shows sufficient plaque control (FMPS < 20%).

• The patient is able to fully understand the nature of the proposed surgery and is able to provide a signed informed consent

Exclusion Criteria:

• General contraindications for dental and/or surgical treatment are present.

• The patient is taking medications or having treatments which have an effect on mucosal healing in general (e.g. steroids, large doses of anti-inflammatory drugs).

• Untreated periodontal conditions

• Patients not willing to participate

Related Conditions & MeSH terms

• Gingival Recession

Intervention

Device:
• Collagen matrix
Mucograft collagen matrix combined with coronal advanced flap

Other:
• autologous connective tissue graft
Soft tissue harvesting from patient palate with coronal advanced flap

Locations

Country	Name	City	State
Spain	Department fo Stomatology II, Faculty of Medicine and Nursery, University of the Basque Country	Leioa	Biscay

Sponsors (1)

Lead Sponsor	Collaborator
Elena Ruiz de Gopegui Palacios

Country where clinical trial is conducted

Spain, 

References & Publications (28)

Aroca S, Molnár B, Windisch P, Gera I, Salvi GE, Nikolidakis D, Sculean A. Treatment of multiple adjacent Miller class I and II gingival recessions with a Modified Coronally Advanced Tunnel (MCAT) technique and a collagen matrix or palatal connective tissue graft: a randomized, controlled clinical trial. J Clin Periodontol. 2013 Jul;40(7):713-20. doi: 10.1111/jcpe.12112. Epub 2013 Apr 30. — View Citation

Atieh MA, Alsabeeha N, Tawse-Smith A, Payne AG. Xenogeneic collagen matrix for periodontal plastic surgery procedures: a systematic review and meta-analysis. J Periodontal Res. 2016 Aug;51(4):438-52. doi: 10.1111/jre.12333. Epub 2015 Nov 7. Review. — View Citation

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Bruno JF, Bowers GM. Histology of a human biopsy section following the placement of a subepithelial connective tissue graft. Int J Periodontics Restorative Dent. 2000 Jun;20(3):225-31. — View Citation

Buti J, Baccini M, Nieri M, La Marca M, Pini-Prato GP. Bayesian network meta-analysis of root coverage procedures: ranking efficacy and identification of best treatment. J Clin Periodontol. 2013 Apr;40(4):372-86. doi: 10.1111/jcpe.12028. Epub 2013 Jan 24. Review. — View Citation

Cairo F, Pagliaro U, Nieri M. Treatment of gingival recession with coronally advanced flap procedures: a systematic review. J Clin Periodontol. 2008 Sep;35(8 Suppl):136-62. doi: 10.1111/j.1600-051X.2008.01267.x. Review. — View Citation

Cardaropoli D, Tamagnone L, Roffredo A, Gaveglio L. Coronally advanced flap with and without a xenogenic collagen matrix in the treatment of multiple recessions: a randomized controlled clinical study. Int J Periodontics Restorative Dent. 2014;34 Suppl 3:s97-102. doi: 10.11607/prd.1605. — View 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. — View Citation

Carnio J, Camargo PM, Kenney EB. Root resorption associated with a subepithelial connective tissue graft for root coverage: clinical and histologic report of a case. Int J Periodontics Restorative Dent. 2003 Aug;23(4):391-8. — View Citation

Chambrone L, Chambrone D, Pustiglioni FE, Chambrone LA, Lima LA. Can subepithelial connective tissue grafts be considered the gold standard procedure in the treatment of Miller Class I and II recession-type defects? J Dent. 2008 Sep;36(9):659-71. doi: 10.1016/j.jdent.2008.05.007. Epub 2008 Jun 26. Review. — View Citation

García-De-la-Fuente AM, Aguirre-Zorzano LA, Estefanía-Fresco R, Roig Ódena L, Aguirre-Urizar JM. Histologic and Clinical Study of Gingival Recession Treated with Subepithelial Connective Tissue Graft: A Case Report. Int J Periodontics Restorative Dent. 20 — View Citation

Goldstein M, Boyan BD, Cochran DL, Schwartz Z. Human histology of new attachment after root coverage using subepithelial connective tissue graft. J Clin Periodontol. 2001 Jul;28(7):657-62. — View Citation

Griffin TJ, Cheung WS, Zavras AI, Damoulis PD. Postoperative complications following gingival augmentation procedures. J Periodontol. 2006 Dec;77(12):2070-9. — View Citation

Harris RJ. Root coverage with a connective tissue with partial thickness double pedicle graft and an acellular dermal matrix graft: a clinical and histological evaluation of a case report. J Periodontol. 1998 Nov;69(11):1305-11. — View Citation

Harris RJ. Successful root coverage: a human histologic evaluation of a case. Int J Periodontics Restorative Dent. 1999 Oct;19(5):439-47. — 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

Majzoub Z, Landi L, Grusovin MG, Cordioli G. Histology of connective tissue graft. A case report. J Periodontol. 2001 Nov;72(11):1607-15. — View Citation

McGuire MK, Nunn M. Evaluation of human recession defects treated with coronally advanced flaps and either enamel matrix derivative or connective tissue. Part 1: Comparison of clinical parameters. J Periodontol. 2003 Aug;74(8):1110-25. — 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

Molnár B, Aroca S, Keglevich T, Gera I, Windisch P, Stavropoulos A, Sculean A. Treatment of multiple adjacent Miller Class I and II gingival recessions with collagen matrix and the modified coronally advanced tunnel technique. Quintessence Int. 2013 Jan;44(1):17-24. doi: 10.3290/j.qi.a28739. — View Citation

Pasquinelli KL. The histology of new attachment utilizing a thick autogenous soft tissue graft in an area of deep recession: a case report. Int J Periodontics Restorative Dent. 1995 Jun;15(3):248-57. — View Citation

Roman A, Câmpian R, Domsa I, Soanca A, Gocan H. Subepithelial connective tissue graft for root coverage: clinical case reports and histologic evaluation. Rom J Morphol Embryol. 2010;51(4):793-7. — View Citation

Soileau KM, Brannon RB. A histologic evaluation of various stages of palatal healing following subepithelial connective tissue grafting procedures: a comparison of eight cases. J Periodontol. 2006 Jul;77(7):1267-73. — View Citation

Steiner GG, Pearson JK, Ainamo J. Changes of the marginal periodontium as a result of labial tooth movement in monkeys. J Periodontol. 1981 Jun;52(6):314-20. — View Citation

Thoma DS, Benic GI, Zwahlen M, Hämmerle CH, Jung RE. A systematic review assessing soft tissue augmentation techniques. Clin Oral Implants Res. 2009 Sep;20 Suppl 4:146-65. doi: 10.1111/j.1600-0501.2009.01784.x. Review. — View Citation

Thoma DS, Mühlemann S, Jung RE. Critical soft-tissue dimensions with dental implants and treatment concepts. Periodontol 2000. 2014 Oct;66(1):106-18. doi: 10.1111/prd.12045. Review. — View Citation

Wennström JL, Lindhe J, Sinclair F, Thilander B. Some periodontal tissue reactions to orthodontic tooth movement in monkeys. J Clin Periodontol. 1987 Mar;14(3):121-9. — View Citation

Wessel JR, Tatakis DN. Patient outcomes following subepithelial connective tissue graft and free gingival graft procedures. J Periodontol. 2008 Mar;79(3):425-30. doi: 10.1902/jop.2008.070325 . — View Citation

* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	millimeters of new attachment	histometry assessment	Change from baseline at following surgery sixth month
Secondary	Length of new cementum	histometry assessment	Change from baseline at following surgery sixth month
Secondary	Length of new junctional epithelium	histometry assessment	Change from baseline at following surgery sixth month
Secondary	length of connective attachment	histometry assessment	Change from baseline at following surgery sixth month
Secondary	complete root coverage	clinical assessment	Change from baseline at following surgery sixth month
Secondary	width of keratinized tissue	clinical assessment	Change from baseline at following surgery sixth month