Skip to content

Conventional or Minimally Invasive Surgical Technique for the Treatment of Furcation Defects Using Enamel Matrix Derivative and Anorganic Bovine Bone - a Randomized Controlled Clinical Trial.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02102360
Enrollment
15
Registered
2014-04-02
Start date
2012-03-31
Completion date
2013-12-31
Last updated
2014-04-02

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

Conditions

Furcation Defects, Periodontal Disease

Keywords

microsurgery, furcation defects, periodontal disease, enamel matrix proteins, bone substitutes

Brief summary

This clinical study compared a conventional surgical technique (CST) and a minimally invasive surgical technique (MIST) in the regenerative treatment of mandibular furcation defects.

Detailed description

Using a split-mouth design, fifteen patients with bilateral class II and III furcation defects were treated with MIST (Test Group) or CST (Control Group). Furcation defects in both groups were filled with anorganic bovine bone (ABB) and enamel matrix derivative (EMD). Patient-centered outcomes including analyses of pain, discomfort, edema, hematoma, root hypersensitivity and daily activities interference were recorded using a Visual Analogue Scale seven days after surgeries. Clinical and radiographic parameters were assessed at baseline and 6 months postoperatively. Data were statistically analysed.

Interventions

DEVICEAnorganic Bovine Bone

used to improve periodontal regenerative procedures.

used to improve periodontal regenerative procedures.

Sponsors

University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

(I) subjects with a diagnosis of periodontitis; (II) presence of one pair of contralateral mandibular molars with buccal / lingual furcation defects; (III) non-smokers; (IV) plaque index \< 20%.

Exclusion criteria

(I) patients that presented systemic disease; (II) had taken antibiotics in the past 6 months prior to surgery; (III) pregnant women or lactating mothers; (IV) molars with periapical disease; (V) cervical restorations or prosthesis closer than 1 mm to fornix; (VI) lingual furcation defects presenting gingival recession (GR)

Design outcomes

Primary

MeasureTime frameDescription
Horizontal clinical attachment level (HCAL)baseline and 6 months after surgical procedureThe clinical measure HCAL was assessed and recorded by an experienced periodontist, blinded to the procedures to assess the efficacy of surgical procedures.

Secondary

MeasureTime frameDescription
Pain Scores on the Visual Analogue Scale7 days after surgery
Discomfort Scores on the Visual Analogue Scale7 days after surgery
Edema Scores on the Visual Analogue Scale7 days after surgery
Hematoma Scores on the Visual Analogue Scale7 days after surgery
Root Hypersensitivity Scores on the Visual Analogue Scale7 days after surgery
Daily Activities Interference Scores on the Visual Analogue Scale7 days after surgery
Vertical clinical attachment level (VCAL)baseline and 6 monthsThe clinical measure HCAL was assessed and recorded by an experienced periodontist, blinded to the procedures to assess the efficacy of surgical procedures.
Probing pocket depth (PPD)baseline and 6 monthsThe clinical measure HCAL was assessed and recorded by an experienced periodontist, blinded to the procedures to assess the efficacy of surgical procedures
Gingival recessionbaseline and 6 monthsThe clinical measure HCAL was assessed and recorded by an experienced periodontist, blinded to the procedures to assess the efficacy of surgical procedures

Other

MeasureTime frameDescription
Digital subtraction radiography density gainbaseline and 6 monthsThe radiographs were obtained with the paralleling technique employing an x-ray unit and a digital sensor . Customized radiographic holders for each patient . Digital subtraction radiographs (DSR) were performed using a specific software. All pairs of baseline and 6-month radiographs for each treated site were then subtracted. Standardized regions of interest (ROIs) were select for each subtracted digital image: (1) placed in the bone's most coronal and central aspect of the furcation defect; and (2) placed at a distant untreated site acting as a radiographic control. The ROIs were not superimposed on any portion of the tooth surface. A software (Image Tool for Windows, Version 3.0, USA) was used to assess radiographic density changes that occurred in ROIs.

Countries

Brazil

Outcome results

None listed

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