Comparison of Root Coverage of Gingival Recessions
Primary Purpose
Gingival Recession
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
collagen matrix
connective tissue graft
Sponsored by
About this trial
This is an interventional treatment trial for Gingival Recession focused on measuring connective tissue graft, transplantation, collagen, autologous, gingiva
Eligibility Criteria
Inclusion Criteria:
- Gingival recessions of class I or II types according to Miller (1985), in contralateral, superior or inferior premolars and / or canines;
- Fine periodontal biotype characterized by the transparency of the North Carolina probe when introduced into the periodontal sulcus (KAN et al., 2003);
- The teeth with gingival recession should not be restored in their cervical portion;
- Periodontal health characterized by absence of bleeding at probing, depth of probing less than 3 mm;
- Visible Plaque Index and Gingival Bleeding Index less than or equal to 30%.
Exclusion Criteria:
- Orthodontic appliances;
- Fixed or removable prostheses involving the premolar teeth with gingival recession;
- Being a smoker;
- Pregnancy or lactation;
- Systemic diseases that may interfere with healing or periodontal health (diabetes, leukemia, hypertension, among others).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Test: collagen matrix
Control: connective tissue graft
Arm Description
Root coverage using collagen matrix
Root coverage using connective tissue graft
Outcomes
Primary Outcome Measures
gingival recession
gingival recession
gingival recession
gingival recession
gingival recession
gingival recession
Secondary Outcome Measures
Width of keratinized mucosa
Full Information
NCT ID
NCT02980055
First Posted
November 28, 2016
Last Updated
November 29, 2016
Sponsor
Universidade Federal do Rio Grande do Norte
1. Study Identification
Unique Protocol Identification Number
NCT02980055
Brief Title
Comparison of Root Coverage of Gingival Recessions
Official Title
Comparison of Root Coverage of Gingival Recessions Using Connective Tissue Graft and Collagen Matrix
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2017 (undefined)
Primary Completion Date
February 2018 (Anticipated)
Study Completion Date
February 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Rio Grande do Norte
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to analyze the percentage of root coverage in Miller class I and II gingival recessions using connective tissue graft and collagen matrix with a two years follow-up.
Detailed Description
A sample calculation using a mean of 2.92 mm of the quantity of keratinized mucosa obtained after six months in the most recent study (McGUIRE; SCHEYER, 2014) using the same collagen matrix with a standard deviation of ± 0.88 mm, a difference of 0.4 mm being chosen as statistically significant. In addition, a 95% bilateral confidence interval and 80% power were used. A sample of 38 individuals per group was obtained. In addition, a 20% loss is expected during follow-up, a total of 46 individuals should be evaluated.
Periapical radiographic examinations should be performed before the collection of data to confirm the absence of bone loss. The following clinical parameters should be evaluated in both test and control groups: visible plaque index, gingival bleeding index, gingival recession, keratinized mucosa width and thickness, probing depth, bleeding on probing and periodontal biotype for each teeth with a North Carolina periodontal probe. The periodontal biotype for each teeth should be rated as thin or thick, according to probe transparency during probing depth. For statistical purposes, percentages of faces with gingival recession should be calculated. These parameters should be evaluated at baseline and at one, three and six months, one and two years post-therapy.
Clinical parameters should be collected by two operators, calibrated by the Kappa test for the keratinized mucosa width and thickness, periodontal biotype, probing depth and gingival recession.
After the inclusion of the patients, anamnesis and initial examination were performed. The subjects should be divided randomly, using a simple draw, in the following two groups: test - (collagen matrix) and control - (connective tissue graft) placebo associated with basic periodontal therapy). The data should be analyzed using descriptive and inferential statistics, with parametric tests, through the software package Social Sciences (SPSS), version 17.0 (free version).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession
Keywords
connective tissue graft, transplantation, collagen, autologous, gingiva
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
46 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Test: collagen matrix
Arm Type
Experimental
Arm Description
Root coverage using collagen matrix
Arm Title
Control: connective tissue graft
Arm Type
Active Comparator
Arm Description
Root coverage using connective tissue graft
Intervention Type
Procedure
Intervention Name(s)
collagen matrix
Other Intervention Name(s)
xenogeneic collagen matrix
Intervention Description
Surgical procedure for root coverage using collagen matrix
Intervention Type
Procedure
Intervention Name(s)
connective tissue graft
Other Intervention Name(s)
autologous
Intervention Description
Surgical procedure for root coverage using connective tissue graft
Primary Outcome Measure Information:
Title
gingival recession
Time Frame
baseline
Title
gingival recession
Time Frame
three months
Title
gingival recession
Time Frame
six months
Title
gingival recession
Time Frame
twelve months
Title
gingival recession
Time Frame
eighteen months
Title
gingival recession
Time Frame
twenty-four months
Secondary Outcome Measure Information:
Title
Width of keratinized mucosa
Time Frame
baseline and three, six, twelve, eighteen and twenty-four months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Gingival recessions of class I or II types according to Miller (1985), in contralateral, superior or inferior premolars and / or canines;
Fine periodontal biotype characterized by the transparency of the North Carolina probe when introduced into the periodontal sulcus (KAN et al., 2003);
The teeth with gingival recession should not be restored in their cervical portion;
Periodontal health characterized by absence of bleeding at probing, depth of probing less than 3 mm;
Visible Plaque Index and Gingival Bleeding Index less than or equal to 30%.
Exclusion Criteria:
Orthodontic appliances;
Fixed or removable prostheses involving the premolar teeth with gingival recession;
Being a smoker;
Pregnancy or lactation;
Systemic diseases that may interfere with healing or periodontal health (diabetes, leukemia, hypertension, among others).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bruno CV Gurgel, Doctor
Phone
+558432154107
Email
bcgurgel@yahoo.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
Samuel B Borges, student
Email
sborges1990@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karyna M Menezes, Master
Organizational Affiliation
Universidade Federal do Rio Grande do Norte
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Comparison of Root Coverage of Gingival Recessions
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