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.

Phase 4

Completed

• Conditions: Furcation Defects; Periodontal Disease
• Interventions: Device: Anorganic Bovine Bone; Device: Enamel Matrix Derivative

• Registration Number: NCT02102360
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-03
• Primary Completion: 2013-11
• Study Completion: 2013-12
• Status Verified: 2014-03
• Study First Submitted: 2014-03-26
• Study First Submitted QC: 2014-03-29
• Last Update Submitted: 2014-03-29
• Study First Posted: 2014-04-02
• Last Update Posted: 2014-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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%.

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Minimally invasive surgical technique (MIST)	Anorganic Bovine Bone	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.
Minimally invasive surgical technique (MIST)	Enamel Matrix Derivative	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.
Conventional surgical technique (CST)	Anorganic Bovine Bone	A conventional surgical technique was performed to access mandibular furcation defects in the control group.
Conventional surgical technique (CST)	Enamel Matrix Derivative	A conventional surgical technique was performed to access mandibular furcation defects in the control group.

Primary Outcome Measures

Name	Time	Method
Horizontal clinical attachment level (HCAL)	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

Name	Time	Method
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)	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.
Probing pocket depth (PPD)	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
Gingival recession	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

Trial Locations

Locations (1)

Department of Oral & Maxillofacial Surgery and Periodontology, School of Dentistry of Ribeirao Preto, University of Sao Paulo; 🇧🇷 Ribeirao Preto, Sao Paulo, Brazil