NCT02195765

Brief Summary

This is a split-mouth, double-blind randomized controlled trial. Computerized linear radiographic measurements were used to detect infrabony defects treated with open flap debridement (OFD) or OFD associated with enamel matrix derivative (EMD), after 24 months. Ten patients presenting 2 or more defects were selected (43 defects). An individualized film holder was used to take standardized radiographs at baseline and after 24 months. Images were digitized and used to measure the distances from the cemento-enamel junction (CEJ) to the alveolar crest (AC), CEJ to the bottom of the defect (BD) and infrabony defect angle.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

June 1, 2002

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2004

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
8.8 years until next milestone

First Submitted

Initial submission to the registry

July 16, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 21, 2014

Completed
Last Updated

July 21, 2014

Status Verified

July 1, 2014

Enrollment Period

2.3 years

First QC Date

July 16, 2014

Last Update Submit

July 17, 2014

Conditions

Chronic Periodontitis

Keywords

Chronic PeriodontitisPeriodontal disease

Outcome Measures

Primary Outcomes (1)

  • Distance from the cemento-enamel junction (CEJ) to the bottom of the defect (BD)

    The most coronal area where the periodontal ligament maintained an even width was identified to measure the most apical extension of the infrabony defect

    24 months

Secondary Outcomes (2)

  • Distance from the CEJ to the bone crest

    24 months

  • Infrabony defect angle

    24 months

Study Arms (2)

enamel matrix derivative

EXPERIMENTAL

Open flap debridement associated with Enamel matrix derivative gel (Emdogain, Straumann)

Drug: enamel matrix derivativeProcedure: Open flap debridement

Open flap debridment

ACTIVE COMPARATOR

Open flap debridement

Procedure: Open flap debridement

Interventions

enamel matrix derivativeDRUG

Open flap debridement associated with enamel matrix derivative

Also known as: Emdogain, Straumann
enamel matrix derivative
Open flap debridementPROCEDURE

Open flap debridement

Open flap debridmentenamel matrix derivative

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of chronic periodontitis
  • presence of at least one pair of interproximal infrabony defects (2-3 walls) adjacent to vital anterior or premolar teeth
  • absence of 2 and 3 mobility degrees
  • probing pocket depth (PPD)≥ 5mm
  • full-mouth plaque score ≤ 20%
  • keratinized tissue width of at least 2mm

You may not qualify if:

  • presence of any systemic disease that could interfere with periodontal treatment
  • infrabony defects with trans-surgical depth ≤4mm
  • antibiotic treatment administered during the last 6 months -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculdade de Odontologia da Universidade de São Paulo (FOUSP)

São Paulo, São Paulo, Brazil

Location

Related Publications (3)

  • Chambrone D, Pasin IM, Chambrone L, Pannuti CM, Conde MC, Lima LA. Treatment of infrabony defects with or without enamel matrix proteins: a 24-month follow-up randomized pilot study. Quintessence Int. 2010 Feb;41(2):125-34.

    PMID: 20165744RESULT

  • Chambrone D, Pasin IM, Conde MC, Panutti C, Carneiro S, Lima LA. Effect of enamel matrix proteins on the treatment of intrabony defects: a split-mouth randomized controlled trial study. Braz Oral Res. 2007 Jul-Sep;21(3):241-6. doi: 10.1590/s1806-83242007000300009.

    PMID: 17710290RESULT

  • Ragghianti Zangrando MS, Chambrone D, Pasin IM, Conde MC, Pannuti CM, de Lima LA. Two-year randomized clinical trial of enamel matrix derivative treated infrabony defects: radiographic analysis. BMC Oral Health. 2014 Dec 4;14:149. doi: 10.1186/1472-6831-14-149.

    PMID: 25475143DERIVED

MeSH Terms

Conditions

Chronic PeriodontitisPeriodontal Diseases

Interventions

enamel matrix proteins

Condition Hierarchy (Ancestors)

PeriodontitisMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Luiz Antonio PA Lima, Associate

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

July 16, 2014

First Posted

July 21, 2014

Study Start

June 1, 2002

Primary Completion

October 1, 2004

Study Completion

October 1, 2005

Last Updated

July 21, 2014

Record last verified: 2014-07

Locations

BR(1)