Gingival RecessionPhase 4NCT03059966
Evaluation of the Inflammatory and Healing Profile After Root Coverage With Emdogain®
A Phase 4 study testing Microsurgery technique for root coverage and Microsurgery technique for root coverage associated to EMD in people with Gingival Recession, run by Rio de Janeiro State University.
Trial 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. Read more about this study
- Who is it for?
- Ages 29 to 53 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Microsurgery technique for root coverage and Microsurgery technique for root coverage associated to EMD
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to Dec 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 29 to 53 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Bilateral gingival recessions in homologous teeth
Who cannot join
- Smokers;
- Systemic diseases;
- Drugs affecting periodontal health/healing.
About this study
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.
- Conditions
- Gingival Recession
- Being tested
- Microsurgery technique for root coverage, Microsurgery technique for root coverage associated to EMD
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microsurgery technique for root coverageProcedure or surgery
Microsurgery technique for root coverage adapted for macrosurgery
Microsurgery technique for root coverage associated to EMDBiological
Microsurgery technique for root coverage adapted for macrosurgery associated to Enamel Matrix Derivative
| Study group | Role | What they receive |
|---|---|---|
| Enamel Matrix Derivative | Experimental | Microsurgery for root coverage associated with Enamel Matrix Derivative Receives: Biological: Microsurgery technique for root coverage associated to EMD |
| Placebo | Placebo comparator | Microsurgery for root coverage associated with a Placebo comparator Receives: Procedure: Microsurgery technique for root coverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-surgical pain
Questionnaire with a Visual Analog Scale from 0 (no pain) to 10 (worst pain)
Measured: 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)
Measured: 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.
Measured: 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
Measured: Baseline, 7 and 14 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study startMar 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rio de Janeiro State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandra Tavares Dias, Rio de Janeiro State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03059966
- Sponsor's protocol ID
- 285.706
- Status last verified
- Feb 2017
- First submitted
- 19 Jan 2017
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Inflammatory and Healing Profile After Root Coverage With Emdogain®
- ClinicalTrials.gov ID
- NCT03059966
- Acronym / sponsor ID
- 285.706
- Conditions
- Gingival Recession
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Rio de Janeiro State UniversityUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enamel Matrix Derivative | Experimental | Biological: Microsurgery technique for root coverage associated to EMDMicrosurgery for root coverage associated with Enamel Matrix Derivative |
| Placebo | Placebo comparator | Procedure: Microsurgery technique for root coverageMicrosurgery for root coverage associated with a Placebo comparator |
Who may qualify
- Ages
- 29 to 53 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Bilateral gingival recessions in homologous teeth
Key exclusion criteria (3 listed)
- Smokers;
- Systemic diseases;
- Drugs affecting periodontal health/healing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microsurgery technique for root coverageMicrosurgery technique for root coverage adapted for macrosurgery | Procedure or surgery | Placebo |
| Microsurgery technique for root coverage associated to EMDMicrosurgery technique for root coverage adapted for macrosurgery associated to Enamel Matrix Derivative | Biological | Enamel Matrix Derivative |
Primary outcome
Post-surgical pain
Time frame: 7 days after surgery
Questionnaire with a Visual Analog Scale from 0 (no pain) to 10 (worst pain)
Root Coverage Score
Time frame: 180 days after surgery
A 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 Analysis
Time frame: 180 days after surgery
Analysis of recession height, recession width, width of keratinized tissue, probing depth, clinical attachment level, and gingival thickness.
Changes in Gingival Fluid Biomarkers
Time frame: Baseline, 7 and 14 days after surgery
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Microsurgery technique for root coverage and Microsurgery technique for root coverage associated to EMD in people with Gingival Recession, run by Rio de Janeiro State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-surgical pain (time frame: 7 days after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.