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Gingival RecessionNCT03667105

Evaluation of Two Types of Matrix (Mucograft® and Mucoderm®) Associated With Coronally Advanced Flap

A study testing CAF, MC and XDM in people with Gingival Recession, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Gingival Recession
What is being tested?
CAF, MC and XDM
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteBrazil
Study dates
15 Aug 2018to 25 Feb 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Laís Fernanda Ferreira Ferraz

    São José dos Campos, São Paulo, 12245905

Other trials in Brazil

About this study

Official title: Evaluation of Two Types of Matrix (Mucograft® and Mucoderm®) Associated With Coronally Advanced Flap for the Treatment of Single Gingival Recessions: Randomized Clinical Trial

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.

Read the detailed description

This is a prospective, parallel and controlled clinical trial. The population that will be evaluated in the study will be selected at Institute of Science and Technology (ICT), São José dos Campos, College of Dentistry.

Seventy-five patients presenting gingival recession will be divided in 3 groups:

  • Group CAF + XDM (25): Periodontal surgery for root coverage through coronally advanced flap technique plus xenogenous dermal matrix graft Mucoderm®.
  • Group CAF + MC (25): Periodontal surgery for root coverage through coronally advanced flap technique plus xenogenous collagen matrix graft Mucograft®.
  • Group CAF (25): Periodontal surgery for root coverage through coronally advanced flap alone.

All surgeries will be performed by a single operator (MPS) at the dental clinic of ICT. Two horizontal incisions will be made at right angles to the adjacent interdental papillae, without interfering with gingival margins of neighboring teeth. Two oblique vertical incisions will be extended beyond the mucogingival junction and a trapezoidal mucoperiosteal flap will be raised up to the mucogingival junction. After, a split-thickness flap will be extended apically, releasing the tension and favoring coronal positioning of the flap. The exposed root surface will be scaled and planed. After the root planning procedures are performed, the epithelial layer from incised papillae will be removed to expose the connective tissue. After this, the group in which the participant is inserted will be revealed to the surgeon. The grafts will be used according to the producers' instructions. In the CAF + MD group, the matrix will be placed without previous hydration with saline solution, whereas in the CAF + XDM group the matrix will be hydrated with sterile saline for 10 minutes. In both grafts groups, the matrix will be cut into the desired dimensions to cover the entire surface of the root and around the bone, being positioned at the CEJ level. The matrix will be sutured independently of the flap, with the porous surface in contact with the tooth and bone, while the smooth surface will be facing the flap. Then, the flap will be coronally positioned and sutured to completely cover the graft. After the surgical procedure, the patients will receive the appropriate postoperative recommendations and sutures will be removed after 10 to 14 days of the surgical procedure.

Clinical parameters will be assessed at baseline and 3 and 6 months postoperatively.

Quantitative data were recorded as mean ± standard deviation (SD), and normality was tested using Shapiro-Wilk tests. The probing depth (PD), relative gingival recession (RGR), clinical attachment level (CAL), keratinized tissue thickness (KTT), keratinized tissue width (KTW), aesthetic (A), postoperative discomfort (PD), dentin hypersensitivity (DH) and tissue edema (TE) values will be examined variance test. Patients' esthetics and discomfort measures using a visual analog scale (VAS) will be analyzed by T-tests. The frequency of complete root coverage will be compared using χ2 tests. Intergroup root coverage esthetic score (RES) comparisons will be performed with a T-test.

Being tested
CAF, MC, XDM
Medical subject headings
Gingival Recession

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CAFProcedure or surgery

    Also called Periodontal plastic surgery

    Periodontal surgical technique to treat gingival recessions.

  • MCOther

    Also called Xenogenous collagen matrix graft (Mucograft®)

    Xenogenous graft placed in the surgical site.

  • XDMOther

    Also called Xenogenous dermal collagen matrix graft (Mucoderm®)

    Xenogenous dermal collagen graft placed in the surgical site.

Study groups in NCT03667105
Study groupRoleWhat they receive
CAF+XDMExperimentalCAF 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.
Receives: Procedure: CAF; Other: XDM
CAF+MCExperimentalCAF 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.
Receives: Procedure: CAF; Other: MC
CAFActive comparatorCAF 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.
Receives: Procedure: CAF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of defect coverage

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

    Measured: 6 months

Secondary outcomes (4)

  1. Root coverage esthetic score

    This analysis will be performed through the Root Coverage Aesthetics Scale (RES, cairo et al., 2009), by 3 blinded and independent examiners at the 6-month post-operative assessment. The RES method uses a "score" that evaluates the following parameters:

    • Level of the gingival margin (0=failure of the root covering, 3=partial covering, 6=total covering);
    • Marginal tissue contour (0=irregular contour, 1=normal contour);
    • Soft tissue texture (0=presence of scar or keloid; 1=absence of scar or keloid);
    • Mucogingival junction alignment: (0=mucogingival line not aligned with the line of the neighboring teeth; 1=mucogingival line aligned with the line of the neighboring teeth);
    • Gingival color (0=color of gingival tissue different from the neighboring tissues; 1=color of treated gingival tissue equal to neighboring tissues).

    According to the sum of scores received, the teeth will be considered: aesthetic (score=10), partially aesthetic (score= 1-9) or without aesthetic (score=0).

    Measured: 6 months

  2. Evaluation of root dentine hypersensitivity with the air blow test

    The assessment of root sensitivity will be performed by applying a blow of air in the region of the surgical procedure for 5 seconds. The patient should mark on a Visual Analogue Scale (VAS) the perceived sensitivity. On this visual scale (range 0-10), the extreme "0" represents "none discomfort or sensitivity" and the extreme "10" represents "extreme discomfort or sensitivity". Thus, higher values represent a worse outcome.

    Measured: 6 months

  3. Evaluation of patient recovery through the report of discomfort and postoperative pain

    At the end of the first post-operative week (7 days) the patients will receive a questionnaire with questions about the occurrence of discomfort and postoperative pain, that will be evaluated by means of a Visual Analog Scale (VAS). On this visual scale (range 0-10), the extreme "0" represents "none discomfort or pain" and the extreme "10" represents "extreme discomfort or pain". Thus, higher values represent a worse outcome. In addition, patients were asked to report the number of analgesics tablets ingested during that week.

    Measured: 7 days

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

    Aesthetic evaluation according to the opinion of the patient will be performed in the baseline and at the 6-month post-operative assessment. Looking at a mirror, the patient will visualize the area of gingival surgery and mark in a Visual Analogue Scale (EVA) the aesthetic of the element in question. On this visual scale, the left extreme represents "very ugly" and the right extreme represents "very beautiful". Thus, closer values of "very beautiful" will represent better outcomes.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2018
  2. Study start15 Aug 2018
  3. Primary completion30 Dec 2019
  4. Study completion25 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03667105
Sponsor's protocol ID
MC - XDM
Status last verified
Apr 2020
First submitted
10 Sep 2018
Last updated
1 May 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 26917493

  • 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.

    PubMed 29087001

  • 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.

    PubMed 21721988

  • 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.

    PubMed 28753100

Questions about this trial

What is this clinical trial studying?

A study testing CAF, MC and XDM in people with Gingival Recession, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of defect coverage (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03667105, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2020.

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