- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03045458
Associations of Alveolar Bone Loss and Interleukin-1β Levels in One and Two Stage Surgical Procedures
Associations of Alveolar Bone Loss, Clinical Parameters and Interleukin-1β Levels in One and Two Stage Surgical Procedures: A Randomized Prospective Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Diyarbakir, Turkey
- Dicle University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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).
|
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 Names:
|
Active Comparator: Bone level dental implant
Bone level dental implants (Straumann AG, Waldenburg, Switzerland ) were inserted in patients group II (n=20).
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
0 and 6 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
0, 3, and 6 month
|
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.
|
0, 3, and 6 month
|
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.
|
0, 3, and 6 month
|
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.
|
0, 3, and 6 month
|
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.
|
0, 3, and 6 month
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: tuba talo yıldırım, Dicle University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D.Ü.D.F.E.K.2010/02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Study Data/Documents
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Alveolar Bone Loss
-
Alexandria UniversityLehigh UniversityCompletedBone Loss | Horizontal Alveolar Bone Loss | Vertical Alveolar Bone LossEgypt
-
Pontificia Universidade Católica do Rio Grande...KU Leuven; ITI International Team for Implantology, Switzerland; Rio Grande do...Not yet recruitingAlveolar Bone Loss | Bone Loss, Alveolar | Grafting Bone | Alveolar Bone Atrophy | Bone Loss, OsteoclasticBrazil
-
Universidad de MurciaUnknownTooth Loss | Bone Loss, Alveolar | Bone Atrophy, AlveolarSpain
-
Università degli Studi di FerraraAzienda USL FerraraRecruitingBone Loss, Alveolar | Dehiscence | Alveolar Ridge EnlargementItaly
-
Postgraduate Institute of Dental Sciences RohtakNot yet recruitingBone Loss, AlveolarIndia
-
University of MichiganActive, not recruiting
-
Rio de Janeiro State UniversityCompleted
-
Semmelweis UniversityPurgo Biologics Inc.; FORM-LabCompletedBone Augmentation | Bone Loss, AlveolarHungary
-
Esraa Salem KamalRecruiting
-
Cairo UniversityRecruiting
Clinical Trials on tissue level dental implant
-
Nada Farouk Hasan Abd El-AzizCairo UniversityCompleted
-
Mohamed Hamdy HelalTanta UniversityCompleted
-
Shiraz University of Medical SciencesShahid Beheshti University of Medical SciencesCompleted
-
ZimVieCompletedPartial Edentulism | Tooth DiseaseUnited States
-
Vilniaus Implantologijos Centro (VIC) KlinikaStraumann GroupActive, not recruitingImmediate ImplantsLithuania
-
University of Alabama at BirminghamZimmer DentalCompleted
-
Cairo UniversityRecruitingHorizontal Atrophy of Edentulous Alveolar RidgeEgypt
-
Cairo UniversityUnknown
-
Aula Dental AvanzadaCompletedDental Implant Failed | Dental Prosthesis FailureSpain
-
Queen Mary University of LondonCompletedOsteoporosis, PostmenopausalUnited Kingdom