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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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ClinicalTrials.gov Identifier: NCT02102360
Recruitment Status : Completed
First Posted : April 2, 2014
Last Update Posted : April 2, 2014
Sponsor:
Information provided by (Responsible Party):
Tulio Bonna Pignaton, University of Sao Paulo

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.

Condition or disease Intervention/treatment Phase
Furcation Defects Periodontal Disease Device: Anorganic Bovine Bone Device: Enamel Matrix Derivative Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : March 2012
Actual Primary Completion Date : November 2013
Actual Study Completion Date : December 2013

Arm Intervention/treatment
Experimental: Minimally invasive surgical technique (MIST)
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
used to improve periodontal regenerative procedures.
Other Name: Anorganic Bovine Bone (Bio-Oss, Geistlich Pharma).

Device: Enamel Matrix Derivative
used to improve periodontal regenerative procedures.
Other Name: Enamel Matrix Derivative (Emdogain - Institute Straumann, Switzerland).

Experimental: Conventional surgical technique (CST)
A conventional surgical technique was performed to access mandibular furcation defects in the control group.
Device: Anorganic Bovine Bone
used to improve periodontal regenerative procedures.
Other Name: Anorganic Bovine Bone (Bio-Oss, Geistlich Pharma).

Device: Enamel Matrix Derivative
used to improve periodontal regenerative procedures.
Other Name: Enamel Matrix Derivative (Emdogain - Institute Straumann, Switzerland).




Primary Outcome Measures :
  1. Horizontal clinical attachment level (HCAL) [ Time Frame: baseline and 6 months after surgical procedure ]
    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 :
  1. Pain Scores on the Visual Analogue Scale [ Time Frame: 7 days after surgery ]
  2. Discomfort Scores on the Visual Analogue Scale [ Time Frame: 7 days after surgery ]
  3. Edema Scores on the Visual Analogue Scale [ Time Frame: 7 days after surgery ]
  4. Hematoma Scores on the Visual Analogue Scale [ Time Frame: 7 days after surgery ]
  5. Root Hypersensitivity Scores on the Visual Analogue Scale [ Time Frame: 7 days after surgery ]
  6. Daily Activities Interference Scores on the Visual Analogue Scale [ Time Frame: 7 days after surgery ]
  7. Vertical clinical attachment level (VCAL) [ Time Frame: baseline and 6 months ]
    The clinical measure HCAL was assessed and recorded by an experienced periodontist, blinded to the procedures to assess the efficacy of surgical procedures.

  8. Probing pocket depth (PPD) [ Time Frame: baseline and 6 months ]
    The clinical measure HCAL was assessed and recorded by an experienced periodontist, blinded to the procedures to assess the efficacy of surgical procedures

  9. Gingival recession [ Time Frame: baseline and 6 months ]
    The clinical measure HCAL was assessed and recorded by an experienced periodontist, blinded to the procedures to assess the efficacy of surgical procedures


Other Outcome Measures:
  1. Digital subtraction radiography density gain [ Time Frame: baseline and 6 months ]

    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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02102360


Locations
Brazil
Department of Oral & Maxillofacial Surgery and Periodontology, School of Dentistry of Ribeirao Preto, University of Sao Paulo
Ribeirao Preto, Sao Paulo, Brazil, 14040-904
Sponsors and Collaborators
University of Sao Paulo

Publications:

Responsible Party: Tulio Bonna Pignaton, 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., University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02102360     History of Changes
Other Study ID Numbers: Mist2014
First Posted: April 2, 2014    Key Record Dates
Last Update Posted: April 2, 2014
Last Verified: March 2014

Keywords provided by Tulio Bonna Pignaton, University of Sao Paulo:
microsurgery, furcation defects, periodontal disease, enamel matrix proteins, bone substitutes

Additional relevant MeSH terms:
Periodontal Diseases
Gingival Diseases
Furcation Defects
Mouth Diseases
Stomatognathic Diseases