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.
- Conditions
- Furcation DefectsPeriodontal Disease
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
(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%.
(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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_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
Department of Oral & Maxillofacial Surgery and Periodontology, School of Dentistry of Ribeirao Preto, University of Sao Paulo🇧🇷Ribeirao Preto, Sao Paulo, Brazil