Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2026-02-28 @ 3:53 AM
Study NCT ID:
NCT03667105
Status:
COMPLETED
Last Update Posted:
2020-05-01
First Post:
2018-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Two Types of Matrix (Mucograft® and Mucoderm®) Associated With Coronally Advanced Flap
Sponsor:
Universidade Estadual Paulista Júlio de Mesquita Filho
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: