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 | Unknown DMC

• 1 other identifier: 10075100
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Gingival recession; Laser-Doppler Flowmetry; Periodontics

Outcome Measures

Primary Outcomes (1)

• Total root coverage measured with a periodontal probe in mm

  Distance from cemento-enamel junction to gingival margin = 0 mm

  One year

Secondary Outcomes (1)

• Keratinized mucosa width measured with a periodontal probe in mm

  One year

Other Outcomes (5)

• Clinical Probing Depth

  one year

• Clinical attachment

  One year

• Thickness of the keratinized mucosa

  One year

Study Arms (2)

SCTG from palatal area with predominance of lamina propria

ACTIVE COMPARATOR

Procedure: Root coverage treatment with subepithelial connective tissue graft

SCTG from palatal area with predominance of submucosa

ACTIVE COMPARATOR

Procedure: Root coverage treatment with subepithelial connective tissue graft

Interventions

Root coverage treatment with subepithelial connective tissue graft PROCEDURE

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

SCTG from palatal area with predominance of lamina propria; SCTG from palatal area with predominance of submucosa

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Bauru School of Dentistry

Bauru, São Paulo, 17012-901, Brazil

RECRUITING

Related Publications (3)

• Zuhr O, Baumer D, Hurzeler M. The addition of soft tissue replacement grafts in plastic periodontal and implant surgery: critical elements in design and execution. J Clin Periodontol. 2014 Apr;41 Suppl 15:S123-42. doi: 10.1111/jcpe.12185.

  PMID: 24640997 BACKGROUND

• Zucchelli G, Mele M, Stefanini M, Mazzotti C, Marzadori M, Montebugnoli L, de Sanctis M. Patient morbidity and root coverage outcome after subepithelial connective tissue and de-epithelialized grafts: a comparative randomized-controlled clinical trial. J Clin Periodontol. 2010 Aug 1;37(8):728-38. doi: 10.1111/j.1600-051X.2010.01550.x. Epub 2010 Jun 24.

  PMID: 20590963 BACKGROUND

• Chambrone L, Tatakis DN. Periodontal soft tissue root coverage procedures: a systematic review from the AAP Regeneration Workshop. J Periodontol. 2015 Feb;86(2 Suppl):S8-51. doi: 10.1902/jop.2015.130674.

  PMID: 25644302 BACKGROUND

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Central Study Contacts

Ricardo R Eustachio, Master of Science student

CONTACT

+55 31 988916111; ricardorabelo@usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master of science student

Study Record Dates

• First Submitted: June 30, 2017
• First Posted: July 5, 2017
• Study Start: February 3, 2017
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2018
• Last Updated: July 5, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)