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.

March 29, 2014 updated by: Tulio Bonna Pignaton, University of Sao Paulo
This clinical study compared a conventional surgical technique (CST) and a minimally invasive surgical technique (MIST) in the regenerative treatment of mandibular furcation defects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

15

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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 Names:
  • Anorganic Bovine Bone (Bio-Oss, Geistlich Pharma).
Device: Enamel Matrix Derivative
used to improve periodontal regenerative procedures.
Other Names:
  • 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 Names:
  • Anorganic Bovine Bone (Bio-Oss, Geistlich Pharma).
Device: Enamel Matrix Derivative
used to improve periodontal regenerative procedures.
Other Names:
  • Enamel Matrix Derivative (Emdogain - Institute Straumann, Switzerland).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline and 6 months after surgical procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Scores on the Visual Analogue Scale
Time Frame: 7 days after surgery
7 days after surgery
Discomfort Scores on the Visual Analogue Scale
Time Frame: 7 days after surgery
7 days after surgery
Edema Scores on the Visual Analogue Scale
Time Frame: 7 days after surgery
7 days after surgery
Hematoma Scores on the Visual Analogue Scale
Time Frame: 7 days after surgery
7 days after surgery
Root Hypersensitivity Scores on the Visual Analogue Scale
Time Frame: 7 days after surgery
7 days after surgery
Daily Activities Interference Scores on the Visual Analogue Scale
Time Frame: 7 days after surgery
7 days after surgery
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.
baseline and 6 months
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
baseline and 6 months
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
baseline and 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (ACTUAL)

November 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

March 26, 2014

First Submitted That Met QC Criteria

March 29, 2014

First Posted (ESTIMATE)

April 2, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

April 2, 2014

Last Update Submitted That Met QC Criteria

March 29, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mist2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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