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 Overview
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Brief Summary
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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
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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.

Conditions
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Furcation Defects, Periodontal Disease

Intervention / Treatment
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* Device: Anorganic Bovine Bone
* Device: Enamel Matrix Derivative


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Minimally invasive surgical technique (MIST)<br>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<br>* used to improve periodontal regenerative procedures.<br>* Other names: Anorganic Bovine Bone (Bio-Oss, Geistlich Pharma).;Device: Enamel Matrix Derivative<br>* used to improve periodontal regenerative procedures.<br>* Other names: Enamel Matrix Derivative (Emdogain - Institute Straumann, Switzerland).;|
| Experimental: Conventional surgical technique (CST)<br>A conventional surgical technique was performed to access mandibular furcation defects in the control group. | Device: Anorganic Bovine Bone<br>* used to improve periodontal regenerative procedures.<br>* Other names: Anorganic Bovine Bone (Bio-Oss, Geistlich Pharma).;Device: Enamel Matrix Derivative<br>* used to improve periodontal regenerative procedures.<br>* Other names: Enamel Matrix Derivative (Emdogain - Institute Straumann, Switzerland).;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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microsurgery, furcation defects, periodontal disease, enamel matrix proteins, bone substitutes