A Phase 4 interventional study of Anorganic Bovine Bone and Enamel Matrix Derivative in Furcation Defects and Periodontal Disease, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-04-02.
Sponsored by University of Sao Paulo · Phase 4, Interventional, and Treatment
This clinical study compared a conventional surgical technique (CST) and a minimally invasive surgical technique (MIST) in the regenerative treatment of mandibular furcation defects.
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.
42 studies on the registry are indexed under Furcation Defects; 13 are open to participants now.
This study's enrollment of 15 is below the median of 27 across 38 interventional studies indexed under Furcation Defects.
Browse Furcation Defects studies →University of Sao Paulo is the lead sponsor of 1,035 studies on the registry; 95 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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(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)
A minimally invasive surgical technique was performed to access mandibular furcation defects in the test group, aiming to perform minimal flap reflection, minimal wound, and gentle handling of the soft and hard tissue in periodontal surgery. The use of a microsurgical approach provides magnification and optimal illumination of the surgical site improving visual acuity. Further advantages may be the reduction of flap reflection during surgery, consequently advantages in wound healing process and benefits in patient's perceptions of the procedure. A less invasive surgical procedure may lead to a less cell demand in the healing process, and a potentially reduced morbidity. The minimally invasive surgical procedures were performed using microscope.
Device: Anorganic Bovine Bone · Device: Enamel Matrix Derivative
A conventional surgical technique was performed to access mandibular furcation defects in the control group.
Device: Anorganic Bovine Bone · Device: Enamel Matrix Derivative
used to improve periodontal regenerative procedures.
Also known as: Anorganic Bovine Bone (Bio-Oss, Geistlich Pharma).
used to improve periodontal regenerative procedures.
Also known as: Enamel Matrix Derivative (Emdogain - Institute Straumann, Switzerland).
Horizontal clinical attachment level (HCAL)
The clinical measure HCAL was assessed and recorded by an experienced periodontist, blinded to the procedures to assess the efficacy of surgical procedures.
Time frame: baseline and 6 months after surgical procedure
Pain Scores on the Visual Analogue Scale
Time frame: 7 days after surgery
Discomfort Scores on the Visual Analogue Scale
Time frame: 7 days after surgery
Edema Scores on the Visual Analogue Scale
Time frame: 7 days after surgery
Hematoma Scores on the Visual Analogue Scale
Time frame: 7 days after surgery
Root Hypersensitivity Scores on the Visual Analogue Scale
Time frame: 7 days after surgery
Daily Activities Interference Scores on the Visual Analogue Scale
Time frame: 7 days after surgery
Vertical clinical attachment level (VCAL)
The clinical measure HCAL was assessed and recorded by an experienced periodontist, blinded to the procedures to assess the efficacy of surgical procedures.
Time frame: baseline and 6 months
Probing pocket depth (PPD)
The clinical measure HCAL was assessed and recorded by an experienced periodontist, blinded to the procedures to assess the efficacy of surgical procedures
Time frame: baseline and 6 months
Gingival recession
The clinical measure HCAL was assessed and recorded by an experienced periodontist, blinded to the procedures to assess the efficacy of surgical procedures
Time frame: baseline and 6 months
Digital subtraction radiography density gain
The 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.
Time frame: baseline and 6 months
The record gives a start of Mar 2012, a primary completion of Nov 2013 and a completion of Dec 2013. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.
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