Associations of Alveolar Bone Loss and Interleukin-1β Levels in One and Two Stage Surgical Procedures
Condition: Implant Infection; Alveolar Bone Loss
MeSH terms: Alveolar Bone Loss
Study type: Interventional

Summary: 
      The present study was compared the level of alveolar bone loss, clinical parameters and IL-1β
      in PICF in one- or two-stage surgical procedures. Half of the patients were performed tissue
      level implant while other half were performed bone level implant.
    

Detailed description: 
      The present study included 40 healthy patients (24 males and 16 females; mean age, 30.75 ±
      8.58 years) who had one tooth absent in the mandible, at the Department of Periodontology,
      Dicle University, Diyarbakir, Turkey, between 2010 and 2011. All patients were informed in
      detail about the study protocol, and they were asked to sign informed consent forms. Ethics
      committee approval was obtained from Dicle University Ethics Committee for this study
      (D.Ü.D.F.E.K.2010/02)

      This study was designed as a prospective, randomized, controlled study. Randomization was
      performed prior to surgery by opening a sequentially numbered sealed envelope corresponding
      to the patient recruitment number. Investigators received randomization instructions only
      after enrolling a subject and immediately prior to surgery. The participants were randomly
      divided into two groups. A one-stage surgical procedure was performed on 20 patients (Group
      I) and a two-stage surgical procedure was performed on the other 20 patients (Group II). The
      primary outcome of the study was a change in alveolar bone level at the implant site between
      T0 and T2 months after surgery measured on CBCT. The secondary outcomes between T0, T1, and
      T2 were changes the level of IL-1β PICF, probing pocket depth (PPD), modified plaque index
      (mPI), modified gingival index (mGI), and modified bleeding index (mBI). All implants
      (Straumann AG, Waldenburg, Switzerland) were inserted by the same periodontist (T.T.Y.) in
      the present study. Pre-surgical radiographic evaluation was conducted using CBCT. Before
      surgery, the patient's mouth was rinsed with chlorhexidine mouthwash. After local anesthesia,
      full thickness flaps were reflected, and osteotomies were prepared in the first mandibular
      molar sites. In these surgical operations, 20 tissue-level and 20 bone-level dental implants
      12 mm in length and 4.8 mm in diameter were inserted in Group I and Group II, respectively.
      Three months later, second-stage surgery was performed and implant exposed into the oral
      cavity. Cover screw was removed and replaced with healing abutments. Three months waited for
      second surgery in bone level implants. Patients of both groups were enrolled in a monthly
      periodontal/peri-implant maintenance program after abutments were connected in which, full
      mouth scaling was performed around all natural teeth and implant surfaces. Oral hygiene
      instructions regarding regular tooth brushing were given and patients were encouraged to
      floss the teeth and periimplant surfaces daily. There was no implant failed during the study
      and adverse event of these treatments.
    

Intervention name(s): tissue level dental implant; Bone level dental implant
Intervention type(s): Device; Device
Intervention description(s): After local anesthesia, full thickness flaps were reflected, and osteotomies were prepared in the first mandibular molar sites. In these surgical operations, 20 tissue-level implants 12 mm in length and 4.8 mm in diameter were inserted in Group I. Cover screw was removed and replaced with healing abutments.; After local anesthesia, full thickness flaps were reflected, and osteotomies were prepared in the first mandibular molar sites. In these surgical operations, 20 bone-level dental implants 12 mm in length and 4.8 mm in diameter were inserted inGroup II. Three months later, second-stage surgery was performed and implant exposed into the oral cavity. Cover screw was removed and replaced with healing abutments. Three months waited for second surgery in bone level implants.
Other intervention name(s): Straumann AG, Waldenburg, Switzerland, dental implant; Straumann AG, Waldenburg, Switzerland, dental implant
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: In the surgical operations, 20 tissue-level and 20 bone-level dental implants 12 mm in length and 4.8 mm in diameter were inserted in Group I and Group II, respectively.
Masking: None (Open Label)
Primary purpose: Other
Keywords: one stage dental implant; two stage dental implant; Interleukin-1β