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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03045458
Recruitment Status : Completed
First Posted : February 7, 2017
Last Update Posted : February 7, 2017
Sponsor:
Collaborator:
Dicle University
Information provided by (Responsible Party):
Tuba Talo yıldırım, Firat University

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.

Condition or disease Intervention/treatment Phase
Implant Infection Alveolar Bone Loss Device: tissue level dental implant Device: Bone level dental implant Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
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)
Masking Description: Only the surgeon knows detail about the groups of participants. Participant, care provider,outcomes assessor have no knowledge of groups
Primary Purpose: Other
Official Title: Associations of Alveolar Bone Loss, Clinical Parameters and Interleukin-1β Levels in One and Two Stage Surgical Procedures: A Randomized Prospective Trial
Actual Study Start Date : September 1, 2010
Actual Primary Completion Date : October 1, 2010
Actual Study Completion Date : June 1, 2011

Arm Intervention/treatment
Active Comparator: Tissue level dental implant
Tissue level dental implants (Straumann AG, Waldenburg, Switzerland) were inserted in patients group I (n=20).
Device: tissue level dental implant
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.
Other Name: Straumann AG, Waldenburg, Switzerland, dental implant

Active Comparator: Bone level dental implant
Bone level dental implants (Straumann AG, Waldenburg, Switzerland ) were inserted in patients group II (n=20).
Device: Bone level dental implant
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 Name: Straumann AG, Waldenburg, Switzerland, dental implant




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

    The primary outcome of the study was a change in alveolar bone level (height in mm) at the 40 implant site between T0 and T2 months after surgery measured on CBCT. All measurements were performed at four sites (mesial, distal, buccal, and lingual) around each dental implant at T0 and T2. These four values were then averaged for each dental implant.

    • Alveolar bone level were measured in millimeters (height in mm) from a fixed reference point on the implant (implant shoulder to the most coronal position of the crestal bone contacting the implant).


Secondary Outcome Measures :
  1. 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)

  2. 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

  3. 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).

  4. 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).

  5. 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).



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • patients in the study who had one tooth absent in the mandible
  • patients in the study should be least 18 years old.

Exclusion Criteria:

Patients in the study were the absence of the following points;

  • poor mouth hygiene,
  • bruxism, dental implants,
  • chemotherapy or radiotherapy,
  • addictions (alcohol, cigarettes, and medications),
  • disease in the jawbones observed clinically or radiographically,
  • pregnancy,
  • antibiotic and/or anti-inflammatory medication use in the last three months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03045458


Locations
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Turkey
Dicle University
Diyarbakir, Turkey
Sponsors and Collaborators
Firat University
Dicle University
Investigators
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Principal Investigator: tuba talo yıldırım Dicle University

Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tuba Talo yıldırım, assistant professor, Firat University
ClinicalTrials.gov Identifier: NCT03045458    
Other Study ID Numbers: D.Ü.D.F.E.K.2010/02
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data can not be used another purpose such as meta-analyses, reanalysis, or replication of results.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Tuba Talo yıldırım, Firat University:
one stage dental implant
two stage dental implant
Interleukin-1β
Additional relevant MeSH terms:
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Alveolar Bone Loss
Bone Diseases
Musculoskeletal Diseases
Bone Resorption
Periodontal Atrophy
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases