Alveolar Bone Loss Clinical Trial
Official title:
Associations of Alveolar Bone Loss, Clinical Parameters and Interleukin-1β Levels in One and Two Stage Surgical Procedures: A Randomized Prospective Trial
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.
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.
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