Generalized Aggressive PeriodontitisOFDNCT03320135
EMD for Treatment of Proximal Class-II Furcation Involvements
A study testing Enamel matrix derivative proteins and Open Flap debridement in people with Generalized Aggressive Periodontitis, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.
Trial summary
The aim of the present study is to evaluate the clinical response of proximal furcations treated with enamel matrix derivative proteins (EMD). Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Generalized Aggressive Periodontitis
- What is being tested?
- Enamel matrix derivative proteins and Open Flap debridement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Oct 2017to 20 May 2019
- Phase
- Interventional
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Diagnosis of generalized aggressive periodontitis (Armitage, 1999; American Academy of Periodontology, 2015);
- Have undergone a first approach for periodontal treatment (full-mouth ultrasonic debridement);
- Presence of one proximal class-II furcation presenting probing depth > 4 mm and bleeding on probing ;
- Good general health;
- Agree to participate in the study and sign the informed consent form (TCLE) after explaining the risks and benefits;
Who cannot join
- Systemic problems (cardiovascular alterations, blood dyscrasias, immunodeficiency - ASA III / IV / V) that contraindicate the periodontal procedure;
- Have used antibiotics and anti-inflammatories in the last six months;
- Smoke ≥ 10 cigarettes/day;
- Pregnant or lactating;
- Chronic use of medications that may alter the response of periodontal tissues;
- Indication of antibiotic prophylaxis for dental procedures;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enamel Matriz Derivate for Treatment of Proximal Class II Furcation Defects: a Randomized Clinical Trial
The aim of the present study is to evaluate the clinical response of proximal furcations treated with enamel matrix derivative proteins (EMD).
Read the detailed description
Proximal class-II furcation represents a challeng to periodontal therapy. Studies show that the ultrasonic non-surgical therapy doesn't work in these defects and the guided tissue regeneration therapy with membranes also demonstrates an unpredictable improvement. Therefore, enamel matrix derivative proteins (EMD) have been proposed as a periodontal regenerative procedure due to their fundamental role in cementum development.
- Conditions
- Generalized Aggressive Periodontitis
- Being tested
- Enamel matrix derivative proteins, Open Flap debridement
- Keywords
- enamel matrix derivative, proximal furcation, randomized clinical trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enamel matrix derivative proteinsProcedure or surgery
Also called Surgical therapy
Open flap debridement to enamel matrix derivative to treat proximal furcation involvements.
Open Flap debridementProcedure or surgery
Also called Surgical therapy
Open flap debridement will be performed to decontaminate the proximal furcation involvements.
| Study group | Role | What they receive |
|---|---|---|
| Enamel matrix derivative proteins | Active comparator | Open flap debridement to enamel matrix derivative application in proximal class-II furcation. Receives: Procedure: Enamel matrix derivative proteins; Procedure: Open Flap debridement |
| Open Flap Debridement | Active comparator | Open flap debridement in proximal class-II furcation. Receives: Procedure: Open Flap debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Horizontal clinical attachment level
horizontal component of the defect
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start20 Oct 2017
- Primary completion20 Oct 2018
- Study completion20 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Generalized Aggressive PeriodontitisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita Filho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mauro Pedrine Santamaria, Universidade Estadual Paulista Júlio de Mesquita Filho
- Investigators
- Mauro M Santamaria, DDS, PhD, Study director, Universidade Estadual Paulista "Julio de Mesquita Filho", ICT/UNESP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03320135
- Sponsor's protocol ID
- UEPJMF ICT
- Acronym
- OFD
- Status last verified
- Jun 2019
- First submitted
- 20 Oct 2017
- Last updated
- 5 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided.
Publications
Casarin RC, Del Peloso Ribeiro E, Nociti FH Jr, Sallum AW, Sallum EA, Ambrosano GM, Casati MZ. A double-blind randomized clinical evaluation of enamel matrix derivative proteins for the treatment of proximal class-II furcation involvements. J Clin Periodontol. 2008 May;35(5):429-37. doi: 10.1111/j.1600-051X.2008.01202.x. Epub 2008 Mar 12.
PubMed 18341602
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enamel Matriz Derivate for Treatment of Proximal Class II Furcation Defects: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03320135
- Acronym / sponsor ID
- OFD / UEPJMF ICT
- Conditions
- Generalized Aggressive Periodontitis
- Keywords
- enamel matrix derivative, proximal furcation, randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita FilhoUniversity, hospital or other
- Study start
- 20 Oct 2017 (actual)
- Primary completion
- 20 Oct 2018 (actual)
- Study completion
- 20 May 2019 (actual)
- First posted
- 25 Oct 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 aim of the present study is to evaluate the clinical response of proximal furcations treated with enamel matrix derivative proteins (EMD).
Detailed description
Proximal class-II furcation represents a challeng to periodontal therapy. Studies show that the ultrasonic non-surgical therapy doesn't work in these defects and the guided tissue regeneration therapy with membranes also demonstrates an unpredictable improvement. Therefore, enamel matrix derivative proteins (EMD) have been proposed as a periodontal regenerative procedure due to their fundamental role in cementum development.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enamel matrix derivative proteins | Active comparator | Procedure: Enamel matrix derivative proteins, Procedure: Open Flap debridementOpen flap debridement to enamel matrix derivative application in proximal class-II furcation. |
| Open Flap Debridement | Active comparator | Procedure: Open Flap debridementOpen flap debridement in proximal class-II furcation. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Diagnosis of generalized aggressive periodontitis (Armitage, 1999; American Academy of Periodontology, 2015);
- Have undergone a first approach for periodontal treatment (full-mouth ultrasonic debridement);
- Presence of one proximal class-II furcation presenting probing depth > 4 mm and bleeding on probing ;
- Good general health;
- Agree to participate in the study and sign the informed consent form (TCLE) after explaining the risks and benefits;
Key exclusion criteria (6 listed)
- Systemic problems (cardiovascular alterations, blood dyscrasias, immunodeficiency - ASA III / IV / V) that contraindicate the periodontal procedure;
- Have used antibiotics and anti-inflammatories in the last six months;
- Smoke ≥ 10 cigarettes/day;
- Pregnant or lactating;
- Chronic use of medications that may alter the response of periodontal tissues;
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 |
|---|---|---|
| Enamel matrix derivative proteinsAlso: Surgical therapyOpen flap debridement to enamel matrix derivative to treat proximal furcation involvements. | Procedure or surgery | Enamel matrix derivative proteins |
| Open Flap debridementAlso: Surgical therapyOpen flap debridement will be performed to decontaminate the proximal furcation involvements. | Procedure or surgery | Enamel matrix derivative proteins, Open Flap Debridement |
Primary outcome
Horizontal clinical attachment level
Time frame: 1 year
horizontal component of the defect
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 5 Jun 2019.
- Results publication: PubMed 18341602Casarin RC, Del Peloso Ribeiro E, Nociti FH Jr, Sallum AW, Sallum EA, Ambrosano GM, Casati MZ. A double-blind randomized clinical evaluation of enamel matrix derivative proteins for the treatment of proximal class-II furcation involvements. J Clin Periodontol. 2008 May;35(5):429-37. doi: 10.1111/j.1600-051X.2008.01202.x. Epub 2008 Mar 12.
- Individual participant dataSharing planned: Undecided. Undecided.
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.
Mauro M Santamaria, DDS, PhD study director
Universidade Estadual Paulista "Julio de Mesquita Filho", ICT/UNESP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enamel matrix derivative proteins and Open Flap debridement in people with Generalized Aggressive Periodontitis, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.
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 5 inclusion and 6 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 5 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Horizontal clinical attachment level (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03320135, which also lists 1 linked publication.
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 5 Jun 2019.