Implant InfectionNCT03045458
Associations of Alveolar Bone Loss and Interleukin-1β Levels in One and Two Stage Surgical Procedures
A study testing tissue level dental implant and Bone level dental implant in people with Implant Infection and Alveolar Bone Loss, run by Firat University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Implant Infection, Alveolar Bone Loss
- What is being tested?
- tissue level dental implant and Bone level dental implant
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2010to 1 Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients in the study who had one tooth absent in the mandible
- patients in the study should be least 18 years old.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Implant Infection, Alveolar Bone Loss
- Being tested
- tissue level dental implant, Bone level dental implant
- Keywords
- one stage dental implant, two stage dental implant, Interleukin-1β
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tissue level dental implantDevice
Also called Straumann AG, Waldenburg, Switzerland, 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.
Bone level dental implantDevice
Also called Straumann AG, Waldenburg, Switzerland, 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.
| Study group | Role | What they receive |
|---|---|---|
| Tissue level dental implant | Active comparator | Tissue level dental implants (Straumann AG, Waldenburg, Switzerland) were inserted in patients group I (n=20). Receives: Device: tissue level dental implant |
| Bone level dental implant | Active comparator | Bone level dental implants (Straumann AG, Waldenburg, Switzerland ) were inserted in patients group II (n=20). Receives: Device: Bone level dental implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of alveolar bone level
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).
Measured: 0 and 6 month
Secondary outcomes (5)
changes level of IL-1β
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)
Measured: 0, 3, and 6 month
changes of PPD
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
Measured: 0, 3, and 6 month
changes of Modified plaque index
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).
Measured: 0, 3, and 6 month
changes of Modified gingival index
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).
Measured: 0, 3, and 6 month
changes of Modified bleeding index
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).
Measured: 0, 3, and 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2017 (estimated)
- Study start1 Sep 2010
- Primary completion1 Oct 2010
- Study completion1 Jun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Implant InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Firat University
- Sponsor type
- University, hospital or other
- Collaborators
- Dicle University
- Responsible party
- Principal investigator, Tuba Talo yıldırım, Firat University
- Investigators
- tuba talo yıldırım, Principal investigator, Dicle University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03045458
- Sponsor's protocol ID
- D.Ü.D.F.E.K.2010/02
- Status last verified
- Feb 2017
- First submitted
- 25 Jan 2017
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data can not be used another purpose such as meta-analyses, reanalysis, or replication of results.
Publications
Talo Yildirim T, Acun Kaya F, Yokus B, Colak M, Ozdemir Kaya E, Tekin G, Saribas E, Uysal E, Guncu GN. Associations of alveolar bone loss and interleukin-1beta levels in one- and two-stage surgical procedures: a randomized prospective trial. Acta Odontol Scand. 2017 Nov;75(8):608-615. doi: 10.1080/00016357.2017.1367959. Epub 2017 Aug 21.
PubMed 28826290
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associations of Alveolar Bone Loss, Clinical Parameters and Interleukin-1β Levels in One and Two Stage Surgical Procedures: A Randomized Prospective Trial
- ClinicalTrials.gov ID
- NCT03045458
- Acronym / sponsor ID
- D.Ü.D.F.E.K.2010/02
- Conditions
- Implant Infection, Alveolar Bone Loss
- Keywords
- one stage dental implant, two stage dental implant, Interleukin-1β
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Firat UniversityUniversity, hospital or other
- Collaborators
- Dicle University
- Study start
- 1 Sep 2010 (actual)
- Primary completion
- 1 Oct 2010 (actual)
- Study completion
- 1 Jun 2011 (actual)
- First posted
- 7 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Tissue level dental implant | Active comparator | Device: tissue level dental implantTissue level dental implants (Straumann AG, Waldenburg, Switzerland) were inserted in patients group I (n=20). |
| Bone level dental implant | Active comparator | Device: Bone level dental implantBone level dental implants (Straumann AG, Waldenburg, Switzerland ) were inserted in patients group II (n=20). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- patients in the study who had one tooth absent in the mandible
- patients in the study should be least 18 years old.
Key exclusion criteria (8 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tissue level dental implantAlso: Straumann AG, Waldenburg, Switzerland, dental implantAfter 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. | Device | Tissue level dental implant |
| Bone level dental implantAlso: Straumann AG, Waldenburg, Switzerland, dental implantAfter 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. | Device | Bone level dental implant |
Primary outcome
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).
5 secondary outcomes
changes level of IL-1β
Time frame: 0, 3, and 6 month
changes of PPD
Time frame: 0, 3, and 6 month
changes of Modified plaque index
Time frame: 0, 3, and 6 month
changes of Modified gingival index
Time frame: 0, 3, and 6 month
changes of Modified bleeding index
Time frame: 0, 3, and 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2017.
- Derived from this study: PubMed 28826290Talo Yildirim T, Acun Kaya F, Yokus B, Colak M, Ozdemir Kaya E, Tekin G, Saribas E, Uysal E, Guncu GN. Associations of alveolar bone loss and interleukin-1beta levels in one- and two-stage surgical procedures: a randomized prospective trial. Acta Odontol Scand. 2017 Nov;75(8):608-615. doi: 10.1080/00016357.2017.1367959. Epub 2017 Aug 21.
- Individual participant dataSharing planned: No. Individual participant data can not be used another purpose such as meta-analyses, reanalysis, or replication of results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
tuba talo yıldırım principal investigator
Dicle University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tissue level dental implant and Bone level dental implant in people with Implant Infection and Alveolar Bone Loss, run by Firat University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of alveolar bone level (time frame: 0 and 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03045458, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2017.