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ASSESSMENT OF CLINICAL PARAMETERS AND LASER DOPPLER FLOWMETRY FOR THE TREATMENT OF MULTIPLE GENGIVAL RECESSIONS WITH TWO TYPES OF SUBEPITELIAL CONNECTIVE GRAFT: RANDOMIZED CLINICAL STUDY

NCT03207971 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-07-05

No results posted yet for this study

Summary

Subepithelial connective tissue graft (SCTG) is considered the gold standard treatment for root coverage in Miller Class I and II single gingival recession. Therefore, scientific evidence is limited for multiple gingival recessions, only with extrapolation from single-tooth data. Depending on area and depth during the removal of the graft from palate, connective tissue presents different anatomic characteristics, geometric shapes and histological composition. Possibly different types of SCTGs present distinct volumetric stability and physiological process of revascularization. This randomized, split-mouth, double blind clinical trial aim to evaluate periodontal parameters (complete root coverage, gingival recession depth and width, gingival thickness, width of keratinized tissue, probing depth, clinical attachment, plaque and bleeding index) and gingival blood flow in recipient sites, comparing sites that received SCTG from palatal area with predominance of lamina propria and predominance of submucosa. Clinical measurements will be evaluated at baseline and 3, 6 and 12 months after surgical procedure. Blood flow flowmetry with laser doppler (LDF) will be analyzed at baseline and 3, 7,14 and 28 days after surgery. Participants will be invited to answer a questionnaire of aesthetic satisfaction and symptoms of pain and discomfort. Two experienced periodontists blind to experimental groups will be invited to observe the clinical outcomes and answer an aesthetic questionnaire. Data analysis will be performed by paired t-test if follow normal distribution or Wilcoxon if follow nonnormal distribution with significance level of 5% (p \<0.05).

Conditions

  • Gingival Recession, Generalized

Interventions

PROCEDURE

Root coverage treatment with subepithelial connective tissue graft

Periodontal plastic surgery aiming root coverage by palatal tissue graft removed from an area with predominance of lamina propria and predominance of submucosa.

Sponsors & Collaborators

  • University of Sao Paulo

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-03
Primary Completion
2017-10-31
Completion
2018-10-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03207971 on ClinicalTrials.gov