NCT03059966

Brief Summary

The purpose of this study was the evaluation of inflammatory and healing profile after root coverage using of Enamel Matrix Derivative. 16 volunteers were selected and submitted to root coverage surgery with subepithelial connective tissue graft, with and without enamel matrix derivative. The patient screening was based in the following inclusion criteria: bilateral recessions in maxillary anterior homologous teeth with aesthetical complaining ou hypersensitivity, non-smokers, healthy and no use of any medication that compromises periodontal health or healing. The split-mouth randomized model was followed in relation to test and control sites. The following clinical parameters were analyzed at baseline and 6-month post-surgery: recession height, recession width, width of keratinized tissue, probing depth, clinical attachment level, and gingival thickness. In addition to the surgical analysis, evaluations of the following inflammatory markers were performed: IL-1β, IL -1RA, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL12, IL-13, IL-15, IL-17, EOTAXIN, FGF, GCSF, GMCSF, IFN-y, IP-10, MCP-1, MIP 1a, PDGF-bb, MIP 1b, RANTES, TNF-α e VEGF. These evaluations were performed at baseline, 7 and 14 days after surgery.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2014

Typical duration for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

2.8 years

First QC Date

January 19, 2017

Last Update Submit

February 16, 2017

Conditions

Gingival Recession

Outcome Measures

Primary Outcomes (4)

  • Post-surgical pain

    Questionnaire with a Visual Analog Scale from 0 (no pain) to 10 (worst pain)

    7 days after surgery

  • Root Coverage Score

    A score including root coverage, marginal gingival tissue contour, mucogingival junction alignment, soft tissue texture and gingival colour according to Cairo et al. (1999)

    180 days after surgery

  • Post-surgical Clinical Analysis

    Analysis of recession height, recession width, width of keratinized tissue, probing depth, clinical attachment level, and gingival thickness.

    180 days after surgery

  • Changes in Gingival Fluid Biomarkers

    Analysis for IL-1β, IL -1RA, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL12, IL-13, IL-15, IL-17, EOTAXIN, FGF, GCSF, GMCSF, IFN-y, IP-10, MCP-1, MIP 1a, PDGF-bb, MIP 1b, RANTES, TNF-α e VEGF by Luminex

    Baseline, 7 and 14 days after surgery

Study Arms (2)

Enamel Matrix Derivative

EXPERIMENTAL

Microsurgery for root coverage associated with Enamel Matrix Derivative

Biological: Microsurgery technique for root coverage associated to EMD

Placebo

PLACEBO COMPARATOR

Microsurgery for root coverage associated with a Placebo comparator

Procedure: Microsurgery technique for root coverage

Interventions

Microsurgery technique for root coveragePROCEDURE

Microsurgery technique for root coverage adapted for macrosurgery

Placebo
Microsurgery technique for root coverage associated to EMDBIOLOGICAL

Microsurgery technique for root coverage adapted for macrosurgery associated to Enamel Matrix Derivative

Enamel Matrix Derivative

Eligibility Criteria

Age29 Years - 53 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Bilateral gingival recessions in homologous teeth

You may not qualify if:

  • Smokers;
  • Systemic diseases;
  • Drugs affecting periodontal health/healing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

January 19, 2017

First Posted

February 23, 2017

Study Start

March 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

February 23, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share