Back to resultsConventional or Minimally Invasive Surgical Technique for the Treatment of Furcation Defects Using Enamel Matrix Derivative and Anorganic Bovine Bone - a Randomized Controlled Clinical Trial.
Primary Purpose
Furcation Defects, Periodontal Disease
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Anorganic Bovine Bone
Enamel Matrix Derivative
Sponsored by
About this trial
This is an interventional treatment trial for Furcation Defects focused on measuring microsurgery, furcation defects, periodontal disease, enamel matrix proteins, bone substitutes
Eligibility Criteria
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)
Sites / Locations
- Department of Oral & Maxillofacial Surgery and Periodontology, School of Dentistry of Ribeirao Preto, University of Sao Paulo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Minimally invasive surgical technique (MIST)
Conventional surgical technique (CST)
Arm Description
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.
A conventional surgical technique was performed to access mandibular furcation defects in the control group.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Pain Scores on the Visual Analogue Scale
Discomfort Scores on the Visual Analogue Scale
Edema Scores on the Visual Analogue Scale
Hematoma Scores on the Visual Analogue Scale
Root Hypersensitivity Scores on the Visual Analogue Scale
Daily Activities Interference Scores on the Visual Analogue Scale
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.
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02102360
Brief Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Furcation Defects, Periodontal Disease
Keywords
microsurgery, furcation defects, periodontal disease, enamel matrix proteins, bone substitutes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Minimally invasive surgical technique (MIST)
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional surgical technique (CST)
Arm Type
Experimental
Arm Description
A conventional surgical technique was performed to access mandibular furcation defects in the control group.
Intervention Type
Device
Intervention Name(s)
Anorganic Bovine Bone
Other Intervention Name(s)
Anorganic Bovine Bone (Bio-Oss, Geistlich Pharma).
Intervention Description
used to improve periodontal regenerative procedures.
Intervention Type
Device
Intervention Name(s)
Enamel Matrix Derivative
Other Intervention Name(s)
Enamel Matrix Derivative (Emdogain - Institute Straumann, Switzerland).
Intervention Description
used to improve periodontal regenerative procedures.
Primary Outcome Measure Information:
Title
Horizontal clinical attachment level (HCAL)
Description
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
Secondary Outcome Measure Information:
Title
Pain Scores on the Visual Analogue Scale
Time Frame
7 days after surgery
Title
Discomfort Scores on the Visual Analogue Scale
Time Frame
7 days after surgery
Title
Edema Scores on the Visual Analogue Scale
Time Frame
7 days after surgery
Title
Hematoma Scores on the Visual Analogue Scale
Time Frame
7 days after surgery
Title
Root Hypersensitivity Scores on the Visual Analogue Scale
Time Frame
7 days after surgery
Title
Daily Activities Interference Scores on the Visual Analogue Scale
Time Frame
7 days after surgery
Title
Vertical clinical attachment level (VCAL)
Description
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
Title
Probing pocket depth (PPD)
Description
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
Title
Gingival recession
Description
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
Other Pre-specified Outcome Measures:
Title
Digital subtraction radiography density gain
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
Department of Oral & Maxillofacial Surgery and Periodontology, School of Dentistry of Ribeirao Preto, University of Sao Paulo
City
Ribeirao Preto
State/Province
Sao Paulo
ZIP/Postal Code
14040-904
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
11338311
Citation
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
17953696
Citation
Cortellini P, Tonetti MS. Minimally invasive surgical technique and enamel matrix derivative in intra-bony defects. I: Clinical outcomes and morbidity. J Clin Periodontol. 2007 Dec;34(12):1082-8. doi: 10.1111/j.1600-051X.2007.01144.x. Epub 2007 Oct 22.
Results Reference
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PubMed Identifier
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Citation
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Citation
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Citation
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Citation
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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.
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