Phase 4
N=41
EMD and/or Bone Substitute for the Treatment of Class II Furcations
Periodontal Disease
Bottom Line
View on ClinicalTrials.gov: NCT02474498 ↗Enrolled (actual)
41
Serious AEs
—
Results posted
Mar 2017
Primary outcome: Primary: Relative Horizontal Clinical Attachment Level (RHCAL) at 12 Months — 2.31; 3.00; 2.57 mm
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- EMD (Drug); βTCP/HA (Device); Flap access surgery (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Campinas, Brazil
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Relative Horizontal Clinical Attachment Level (RHCAL) at 12 Months |
2.31; 3.00; 2.57 | — |
| SECONDARY Relative Vertical Clinical Attachment Level (RVCAL) at 12 Months |
12.31; 12.36; 11.93 | — |
| SECONDARY Periodontal Probing Depth at 12 Months |
2.38; 2.57; 2.36 | — |
| SECONDARY Relative Gingival Margin Position (RGMP) at 12 Months |
9.92; 9.79; 9.57 | — |
Summary
To clinically evaluate the treatment of mandibular class II furcation defects with enamel matrix derivative (EMD) and/or a bone substitute graft make of beta tricalcium phosphate/hydroxyapatite (βTCP/HA).
Eligibility Criteria
Inclusion Criteria
- Males and females, between 18-75 years of age;
- Presence of a mandibular molar with buccal class-II furcation defect, presenting PD ≥ 4mm, bleeding on probing (BOP), minimum (<1 mm) or no gingival recession after non-surgical therapy;
- Good general health;
- Minimum interproximal bone loss (< 2 mm).
Exclusion Criteria
- Pregnant or lactating;
- Required antibiotic pre-medication for the performance of periodontal examination and treatment;
- Suffered from any other systemic diseases (cardiovascular, pulmonary, liver, cerebral, diseases or diabetes);
- Had received antibiotic treatment in the previous 3 months;
- Were taking long-term anti-inflammatory drugs;
- Had received a course of periodontal treatment within the last 6 months;
- Smokers.
Data sourced from ClinicalTrials.gov (NCT02474498). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.