Clinical Trial: Associations of Alveolar Bone Loss and Interleukin-1β Levels in One and Two Stage Surgical Procedures

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary:

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 inse
Sponsor: Firat University

Current Primary Outcome: change of alveolar bone level [ Time Frame: 0 and 6 month ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• changes level of IL-1β [ Time Frame: 0, 3, and 6 month ]

  The secondary outcome of the study was change the level of IL-1β pg/ml between T0, T1, and T2. To obtain PICF, filter paper strips were gently inserted into the peri-implant crevice for 30 s at the mesial, distal, buccal, and lingual sites of the dental implant. A Williams periodontal probe was used for all clinical measurements.These parameters were recorded for evaluating the clinical status of the dental implants. All measurements were performed at four sites around each dental implant. For the statistical analysis, median of the four measurements at each implant was used.

  • The level of IL-1β pg/ml (weight in picogram, weight in milliliter)
• changes of PPD [ Time Frame: 0, 3, and 6 month ]

  The secondary outcome of the study was change of the PPD between T0, T1, and T2. A Williams periodontal probe was used for all clinical measurements.These parameters were recorded for evaluating the clinical status of the dental implants. All measurements were performed at four sites around each dental implant. For the statistical analysis, median of the four measurements at each implant was used.

  • Probing pocket depth (PPD) (depth in mm), were measured
• changes of Modified plaque index [ Time Frame: 0, 3, and 6 month ]

  The secondary outcome of the study was change of the Modified plaque index between T0, T1, and T2. A Williams periodontal probe was used for all clinical measurements.These parameters were recorded for evaluating the clinical status of the dental implants. All measurements were performed at four sites around each dental implant. For the statistical analysis, median of the four measurements at each implant was used.

  • Modified plaque index (0=no plaque, 1= mild plaque, 2= moderate plaque, 3=severe plaque).
• changes of Modified gingival index [ Time Frame: 0, 3, and 6 month ]

  The secondary outcome of the study was change of the Modified gingival index between T0, T1, and T2. A Williams periodontal probe was used for all clinical measurements.These parameters were recorded for evaluating the clinical status of the dental implants. All measurements were performed at four sites around each dental implant. For the statistical analysis, median of the four measurements at each implant was used.

  • Modified gingival index (0=healthy, 1=mild inflammation 2= moderate inflammation 3=severe inflammation).
• changes of Modified bleeding index [ Time Frame: 0, 3, and 6 month ]

  The secondary outcome of the study was change of the Modified bleeding index between T0, T1, and T2. A Williams periodontal probe was used for all clinical measurements.These parameters were recorded for evaluating the clinical status of the dental implants. All measurements were performed at four sites around each dental implant. For the statistical analysis, median of the four measurements at each implant was used.

  • Modified bleeding index (0= no bleeding, 1= mild bleeding, 2= moderate bleeding, 3=severe bleeding).

Original Secondary Outcome: Same as current

Information By: Firat University

Dates:
Date Received: January 25, 2017
Date Started: September 1, 2010
Date Completion:
Last Updated: February 6, 2017
Last Verified: February 2017