Dental Implant FailedNCT04572490
Comparison of Narrow and Regular Implants
An observational study of Dental Implant Failed and Alveolar Bone Loss, run by T.C. Dumlupınar Üniversitesi at 1 site in Turkey (Türkiye).
Trial summary
The study was designed as a retrospective, parallel, two years longitudinal pilot trial. Twenty-eight patients (mean age: 48.34 ± 6.06) aged between 35 and 60 years and 66 TiUnite surfaces (Nobel Biocare Parallel Conical Connection), bone level dental implant were included in the study. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implant Failed, Alveolar Bone Loss, Complication,Postoperative
- What is being tested?
- periapical radiograph
- How many people
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Jun 2019to 28 Oct 2019
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All dental implants involved are the Nobel Biocare Parallel CC brand (Nobel Biocare, Gothenburg, Sweden) with a TiUnite surface, and it defined a regular diameter of 4.3 mm and narrow diameter of 3.75 mm. Dental implants divided into two groups according to implant diameter, the NPI group comprised 3.75 mm diameter (NP, Ø= 3.75 mm) implants, and the RPI group comprised 4.3 mm diameter (RP, Ø= 4.3mm) implants (implant lengths: 10 mm-13 mm).
Who may be able to join
- the presence of a dental implant treated with fixed prosthetic restoration placed in the posterior jaw followed for at least one year after functional loading,
- no active periodontal disease,
- no history of penicillin allergy -
- no radiotherapy to the head and neck region
- smoking less than ten cigarettes per day,
- no bone augmentation surgery before or during dental implant surgery,
Show all 10Show fewer
- aged over 18,
- mesial or distal additional crown restoration was not performed,
- no use of medications that affect bone metabolism and
- not pregnant or lactating.
Who cannot join
- the implants placed in the anterior region,
- immediate placing and loading
- augmented before or using a graft membrane with surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kütahya Health Sciences University Faculty of Dentistry
Kütahya, 43100
About this study
Official title: The Comparison of Narrow and Regular Platform Dental Implants Placed Posterior Regions
The study was designed as a retrospective, parallel, two years longitudinal pilot trial. Twenty-eight patients (mean age: 48.34 ± 6.06) aged between 35 and 60 years and 66 TiUnite surfaces (Nobel Biocare Parallel Conical Connection), bone level dental implant were included in the study. The implants were divided into two different groups according to the NPIs and regular platform implants(RPIs). The mean implant lengths, plaque index(PI), gingival index(GI), periodontal pocket depth(PD), gingival recession(GR), keratinized gingival width(KGW) and bleeding on probing(BOP) values were recorded. The Student's t-test used for between-group comparison.
Read the detailed description
Fifty-one participants and 123 dental implants were evaluated; twenty-three participants and 49 dental implants were excluded because of the different commercial brand dental implant (AstraTech, Straumann Roxolid, Bilimplant) and declining to participate. Seventy-four TiUnite dental implants were included in the study, but 8 TiUnite surface implants placed in the anterior region were excluded. Consequently, 15 male and 13 female patients and 66 dental implants were included in the study. This randomized retrospective clinical trial was designed according to the Consolidated Standards of Reporting Trials (CONSORT) Statement guidelines. A CONSORT Flow Chart of this study was shown in Figure 118.
The assignment was performed according to the dental implant diameters to include cases in the NPI and RPI which are the test and control groups. All dental implants involved are the Nobel Biocare Parallel CC brand (Nobel Biocare, Gothenburg, Sweden) with a TiUnite surface, and it defined a regular diameter of 4.3 mm and narrow diameter of 3.75 mm. Dental implants divided into two groups according to implant diameter, the NPI group comprised 3.75 mm diameter (NP, Ø= 3.75 mm) implants, and the RPI group comprised 4.3 mm diameter (RP, Ø= 4.3mm) implants (implant lengths: 10 mm-13 mm).
Clinical Measurements The clinical measurements were recorded at follow-up sessions using a periodontal probe that was calibrated in 1 mm increments. The clinical measurements were as follows: 1) plaque index (PI); 2) gingival index (GI); 3) probing depth (PD), the distance between the gingival margin and the bottom of a pocket; 4) clinical attachment level (CAL); the distance from the neck of the implant and the bottom of the pocket; 5) bleeding on probing (BOP); 6) keratinized gingival width (KGW), the height of peri-implant keratinized mucosa; 7) gingival recession (GR), the distance between the neck of the implant and the gingival margin. The same researcher performed all clinical measurements. A calibration protocol was applied to the reliability of measurements. PI, GI, PD, CAL, GR, KGW meaurements on five patients and ten peri-implant values were assessed. Calibration was accepted when measurements were 90% similar20. All clinical measurements were recorded for four sites (mesiobuccal, distobuccal, mid-buccal, mesiopalatal, midpalatal, and distopalatal) per peri-implant region. PD and PI measurements are reliable in peri-implantitis diagnosis21.
Prosthetic complications of patients were also evaluated clinically. Veneer ceramic chipping, abutment screw loosening or fracture, implant fracture, loss of retention were recorded.
Radiographic Measurements The studies have reported that periapical radiographs taken with the parallel technique are reliable in determining the MBL changes at different follow-ups. Digital periapical radiographs of the posterior region were obtained using a parallel method at follow-up sessions. MBL measurements were provided on periapical radiographs by a software program (Mediadent Software, The Dental Imaging Company, London, England). Ten radiographic MBL measurements around peri-implant were performed twice with an interval of 3 weeks, and researcher calibration was accepted when measurements were similar as %90. MBL was measured separately from the mesial and distal parts and also which the average of the two measurements. The reference points for the assessments are the implant shoulder and the most apical end-point of the bone-implant contact point. The vertical length between these two points is defined as MBL.
- Being tested
- periapical radiograph
- Keywords
- Dental implants Alveolar bone loss
- Medical subject headings
- Alveolar Bone Loss, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
periapical radiographDiagnostic test
alveolar bone loss measurement on standardized parallel periapical radiograph
| Study group | Role | What they receive |
|---|---|---|
| Narrow platform implant | All measurements will be obtained after dental implant functional loading. Periodontal index will be recorded and alveolar bone loss measurements will be made on periapical radiographs. Receives: Diagnostic Test: periapical radiograph | |
| Regular platform implants | All measurements will be obtained after dental implant functional loading. Periodontal index will be recorded and alveolar bone loss measurements will be made on periapical radiographs. Receives: Diagnostic Test: periapical radiograph |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal bone loss
Peri-implant alveolar bone loss measurements on software program
Measured: change from baseline marginal bone loss at postoperatively 24. month
Secondary outcomes (1)
Keratinized gingival width
Peri-implant keratinized gingival width measurements with clinically
Measured: change from baseline peri-implant keratinized gingival width at postoperatively 24. month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start27 Jun 2019
- Primary completion31 Aug 2019
- Study completion28 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Implant FailedStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- T.C. Dumlupınar Üniversitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berceste Guler, T.C. Dumlupınar Üniversitesi
- Investigators
- Berceste Guler, PhD, Principal investigator, Kütahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04572490
- Sponsor's protocol ID
- 2019/07-4
- Status last verified
- Sep 2020
- First submitted
- 24 Sep 2020
- Last updated
- 1 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Narrow and Regular Platform Dental Implants Placed Posterior Regions
- ClinicalTrials.gov ID
- NCT04572490
- Acronym / sponsor ID
- 2019/07-4
- Keywords
- Dental implants Alveolar bone loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- T.C. Dumlupınar ÜniversitesiUniversity, hospital or other
- Study start
- 27 Jun 2019 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 28 Oct 2019 (actual)
- First posted
- 1 Oct 2020 (actual)
- 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 study was designed as a retrospective, parallel, two years longitudinal pilot trial. Twenty-eight patients (mean age: 48.34 ± 6.06) aged between 35 and 60 years and 66 TiUnite surfaces (Nobel Biocare Parallel Conical Connection), bone level dental implant were included in the study. The implants were divided into two different groups according to the NPIs and regular platform implants(RPIs). The mean implant lengths, plaque index(PI), gingival index(GI), periodontal pocket depth(PD), gingival recession(GR), keratinized gingival width(KGW) and bleeding on probing(BOP) values were recorded. The Student's t-test used for between-group comparison.
Detailed description
Fifty-one participants and 123 dental implants were evaluated; twenty-three participants and 49 dental implants were excluded because of the different commercial brand dental implant (AstraTech, Straumann Roxolid, Bilimplant) and declining to participate. Seventy-four TiUnite dental implants were included in the study, but 8 TiUnite surface implants placed in the anterior region were excluded. Consequently, 15 male and 13 female patients and 66 dental implants were included in the study. This randomized retrospective clinical trial was designed according to the Consolidated Standards of Reporting Trials (CONSORT) Statement guidelines. A CONSORT Flow Chart of this study was shown in Figure 118.
The assignment was performed according to the dental implant diameters to include cases in the NPI and RPI which are the test and control groups. All dental implants involved are the Nobel Biocare Parallel CC brand (Nobel Biocare, Gothenburg, Sweden) with a TiUnite surface, and it defined a regular diameter of 4.3 mm and narrow diameter of 3.75 mm. Dental implants divided into two groups according to implant diameter, the NPI group comprised 3.75 mm diameter (NP, Ø= 3.75 mm) implants, and the RPI group comprised 4.3 mm diameter (RP, Ø= 4.3mm) implants (implant lengths: 10 mm-13 mm).
Clinical Measurements The clinical measurements were recorded at follow-up sessions using a periodontal probe that was calibrated in 1 mm increments. The clinical measurements were as follows: 1) plaque index (PI); 2) gingival index (GI); 3) probing depth (PD), the distance between the gingival margin and the bottom of a pocket; 4) clinical attachment level (CAL); the distance from the neck of the implant and the bottom of the pocket; 5) bleeding on probing (BOP); 6) keratinized gingival width (KGW), the height of peri-implant keratinized mucosa; 7) gingival recession (GR), the distance between the neck of the implant and the gingival margin. The same researcher performed all clinical measurements. A calibration protocol was applied to the reliability of measurements. PI, GI, PD, CAL, GR, KGW meaurements on five patients and ten peri-implant values were assessed. Calibration was accepted when measurements were 90% similar20. All clinical measurements were recorded for four sites (mesiobuccal, distobuccal, mid-buccal, mesiopalatal, midpalatal, and distopalatal) per peri-implant region. PD and PI measurements are reliable in peri-implantitis diagnosis21.
Prosthetic complications of patients were also evaluated clinically. Veneer ceramic chipping, abutment screw loosening or fracture, implant fracture, loss of retention were recorded.
Radiographic Measurements The studies have reported that periapical radiographs taken with the parallel technique are reliable in determining the MBL changes at different follow-ups. Digital periapical radiographs of the posterior region were obtained using a parallel method at follow-up sessions. MBL measurements were provided on periapical radiographs by a software program (Mediadent Software, The Dental Imaging Company, London, England). Ten radiographic MBL measurements around peri-implant were performed twice with an interval of 3 weeks, and researcher calibration was accepted when measurements were similar as %90. MBL was measured separately from the mesial and distal parts and also which the average of the two measurements. The reference points for the assessments are the implant shoulder and the most apical end-point of the bone-implant contact point. The vertical length between these two points is defined as MBL.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Narrow platform implant | – | Diagnostic Test: periapical radiographAll measurements will be obtained after dental implant functional loading. Periodontal index will be recorded and alveolar bone loss measurements will be made on periapical radiographs. |
| Regular platform implants | – | Diagnostic Test: periapical radiographAll measurements will be obtained after dental implant functional loading. Periodontal index will be recorded and alveolar bone loss measurements will be made on periapical radiographs. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All dental implants involved are the Nobel Biocare Parallel CC brand (Nobel Biocare, Gothenburg, Sweden) with a TiUnite surface, and it defined a regular diameter of 4.3 mm and narrow diameter of 3.75 mm. Dental implants divided into two groups according to implant diameter, the NPI group comprised 3.75 mm diameter (NP, Ø= 3.75 mm) implants, and the RPI group comprised 4.3 mm diameter (RP, Ø= 4.3mm) implants (implant lengths: 10 mm-13 mm).
Key inclusion criteria (10 listed)
- the presence of a dental implant treated with fixed prosthetic restoration placed in the posterior jaw followed for at least one year after functional loading,
- no active periodontal disease,
- no history of penicillin allergy -
- no radiotherapy to the head and neck region
- smoking less than ten cigarettes per day,
Key exclusion criteria (3 listed)
- the implants placed in the anterior region,
- immediate placing and loading
- augmented before or using a graft membrane with surgery
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 |
|---|---|---|
| periapical radiographalveolar bone loss measurement on standardized parallel periapical radiograph | Diagnostic test | Narrow platform implant, Regular platform implants |
Primary outcome
Marginal bone loss
Time frame: change from baseline marginal bone loss at postoperatively 24. month
Peri-implant alveolar bone loss measurements on software program
1 secondary outcome
Keratinized gingival width
Time frame: change from baseline peri-implant keratinized gingival width at postoperatively 24. 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 1 Oct 2020.
- Individual participant dataSharing planned: No
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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.
Berceste Guler, PhD principal investigator
Kütahya Health Sciences University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Implant Failed and Alveolar Bone Loss, run by T.C. Dumlupınar Üniversitesi 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 10 inclusion and 3 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 1 Oct 2020. 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?
Marginal bone loss (time frame: change from baseline marginal bone loss at postoperatively 24. month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2020; AzTrials last refreshed its copy on 27 Oct 2026.