Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
46 participants
INTERVENTIONAL
2017-02-28
2019-02-28
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Test: collagen matrix
Root coverage using collagen matrix
collagen matrix
Surgical procedure for root coverage using collagen matrix
Control: connective tissue graft
Root coverage using connective tissue graft
connective tissue graft
Surgical procedure for root coverage using connective tissue graft
Interventions
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collagen matrix
Surgical procedure for root coverage using collagen matrix
connective tissue graft
Surgical procedure for root coverage using connective tissue graft
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
45 Years
ALL
No
Sponsors
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Universidade Federal do Rio Grande do Norte
OTHER
Responsible Party
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Karyna de Melo Menezes
Principal Invastigator
Principal Investigators
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Karyna M Menezes, Master
Role: PRINCIPAL_INVESTIGATOR
Universidade Federal do Rio Grande do Norte
Central Contacts
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Other Identifiers
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UFRN-3
Identifier Type: -
Identifier Source: org_study_id
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