Skip to content

Evaluation of the Inflammatory and Healing Profile After Root Coverage With Emdogain®

Evaluation of the Inflammatory and Healing Profile After Root Coverage With Emdogain®

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03059966
Enrollment
16
Registered
2017-02-23
Start date
2014-03-31
Completion date
2016-12-31
Last updated
2017-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingival Recession

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.

Interventions

PROCEDUREMicrosurgery technique for root coverage

Microsurgery technique for root coverage adapted for macrosurgery

BIOLOGICALMicrosurgery technique for root coverage associated to EMD

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

Sponsors

Rio de Janeiro State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
29 Years to 53 Years
Healthy volunteers
Yes

Inclusion criteria

* Bilateral gingival recessions in homologous teeth

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Post-surgical pain7 days after surgeryQuestionnaire with a Visual Analog Scale from 0 (no pain) to 10 (worst pain)
Root Coverage Score180 days after surgeryA score including root coverage, marginal gingival tissue contour, mucogingival junction alignment, soft tissue texture and gingival colour according to Cairo et al. (1999)
Post-surgical Clinical Analysis180 days after surgeryAnalysis of recession height, recession width, width of keratinized tissue, probing depth, clinical attachment level, and gingival thickness.
Changes in Gingival Fluid BiomarkersBaseline, 7 and 14 days after surgeryAnalysis 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026