NCT03667105

Brief Summary

The aim of this study is to evaluate clinically the results of two types of matrix (Geistlich Mucograft® and Mucoderm®) associated with CAF technique for the treatment of gingival recessions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2018

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

September 10, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 12, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2020

Completed
Last Updated

May 1, 2020

Status Verified

April 1, 2020

Enrollment Period

1.4 years

First QC Date

September 10, 2018

Last Update Submit

April 30, 2020

Conditions

Gingival Recession

Outcome Measures

Primary Outcomes (1)

  • Percentage of defect coverage

    Percentage mean (%) of root surface covered by the surgical treatment, measured through a periodontal probe.

    6 months

Secondary Outcomes (4)

  • Root coverage esthetic score

    6 months

  • Evaluation of root dentine hypersensitivity with the air blow test

    6 months

  • Evaluation of patient recovery through the report of discomfort and postoperative pain

    7 days

  • Aesthetic evaluation according to patient through Visual Analog Scale (EVA)

    6 months

Study Arms (3)

CAF+XDM

EXPERIMENTAL

CAF treatment will be performed by starting with two divergent releasing incisions lateral to the recessed area. A sulcular incision will be made to unite the releasing incisions and the flap will be raised beyond the mucogingival junction (MGJ) in split-full-split thickness. Additionally, this group will receive the xenogenous dermal collagen matrix graft (AXDM - Mucoderm®, Botiss,) on the recessed area before the sutures. Then, the flap will be coronally positioned and sutured to completely cover the graft.

Procedure: CAFOther: XDM

CAF+MC

EXPERIMENTAL

CAF treatment will be performed by starting with two divergent releasing incisions lateral to the recessed area. A sulcular incision will be made to unite the releasing incisions and the flap will be raised beyond the mucogingival junction (MGJ) in split-full-split thickness. Additionally, this group will receive the xenogenous collagen matrix graft (Mucograft®, Geistlich Pharma) on the recessed area before the sutures. Then, the flap will be coronally positioned and sutured to completely cover the graft.

Procedure: CAFOther: MC

CAF

ACTIVE COMPARATOR

CAF treatment will be performed by starting with two divergent releasing incisions lateral to the recessed area. A sulcular incision will be made to unite the releasing incisions and the flap will be raised beyond the mucogingival junction (MGJ) in split-full-split thickness. Then, the flap will be coronally positioned and sutured to completely cover the graft. This group will be the control group.

Procedure: CAF

Interventions

CAFPROCEDURE

Periodontal surgical technique to treat gingival recessions.

Also known as: Periodontal plastic surgery
CAFCAF+MCCAF+XDM
MCOTHER

Xenogenous graft placed in the surgical site.

Also known as: Xenogenous collagen matrix graft (Mucograft®)
CAF+MC
XDMOTHER

Xenogenous dermal collagen graft placed in the surgical site.

Also known as: Xenogenous dermal collagen matrix graft (Mucoderm®)
CAF+XDM

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients presenting Miller class I or II gingival recession in the maxillary canines or premolars;
  • Teeth included in the study should present pulp vitality and no associated with carious or cervical lesion;
  • Patients presenting no signs of active periodontal disease and full-mouth plaque and bleeding score ≤ 20%;
  • Probing depth ˂ 3 mm in the included and adjacent teeth, presenting no signs of bleeding or attachment loss;
  • Patients older than 18 years old;
  • Patients who agreed to participate and signed an informed consent form.

You may not qualify if:

  • Patients with systemic problems (cardiovascular, blood dyscrasias, immunodeficiency, and diabetes, among others) that will contraindicate the surgical procedure;
  • Patients taking medications known to interfere with the wound healing process or that contraindicate the surgical procedure;
  • pregnant or lactating women;
  • Smokers;
  • Patients who underwent periodontal surgery in the area of interest;
  • Patients with orthodontic therapy in progress.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laís Fernanda Ferreira Ferraz

São José dos Campos, São Paulo, 12245905, Brazil

Location

Related Publications (4)

  • Moreira ARO, Santamaria MP, Silverio KG, Casati MZ, Nociti Junior FH, Sculean A, Sallum EA. Coronally advanced flap with or without porcine collagen matrix for root coverage: a randomized clinical trial. Clin Oral Investig. 2016 Dec;20(9):2539-2549. doi: 10.1007/s00784-016-1757-8. Epub 2016 Feb 26.

    PMID: 26917493BACKGROUND

  • Tonetti MS, Cortellini P, Pellegrini G, Nieri M, Bonaccini D, Allegri M, Bouchard P, Cairo F, Conforti G, Fourmousis I, Graziani F, Guerrero A, Halben J, Malet J, Rasperini G, Topoll H, Wachtel H, Wallkamm B, Zabalegui I, Zuhr O. Xenogenic collagen matrix or autologous connective tissue graft as adjunct to coronally advanced flaps for coverage of multiple adjacent gingival recession: Randomized trial assessing non-inferiority in root coverage and superiority in oral health-related quality of life. J Clin Periodontol. 2018 Jan;45(1):78-88. doi: 10.1111/jcpe.12834. Epub 2017 Nov 21.

    PMID: 29087001BACKGROUND

  • 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.

    PMID: 21721988BACKGROUND

  • Sangiorgio JPM, Neves FLDS, Rocha Dos Santos M, Franca-Grohmann IL, Casarin RCV, Casati MZ, Santamaria MP, Sallum EA. Xenogenous Collagen Matrix and/or Enamel Matrix Derivative for Treatment of Localized Gingival Recessions: A Randomized Clinical Trial. Part I: Clinical Outcomes. J Periodontol. 2017 Dec;88(12):1309-1318. doi: 10.1902/jop.2017.170126. Epub 2017 Jul 28.

    PMID: 28753100BACKGROUND

MeSH Terms

Conditions

Gingival Recession

Interventions

MucograftMucoderm

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Officials

  • Mauro P Santamaria, PhD

    ICT-UNESP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 10, 2018

First Posted

September 12, 2018

Study Start

August 15, 2018

Primary Completion

December 30, 2019

Study Completion

February 25, 2020

Last Updated

May 1, 2020

Record last verified: 2020-04

Locations

BR(1)