Dental Implant FailedNCT05390242
Peri-implant Marginal Bone Loss and Implant Failure in Patients With Smoking Habit
An observational study of Dental Implant Failed and Marginal Bone Loss, run by University of Barcelona at 1 site in Spain.
Trial summary
The impact of smoking on dental implant failure has been a constant topic of discussion for the past decade and the current literature confronts the inconclusive evidence of tobacco for a marginal bone loss risk factor. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implant Failed, Marginal Bone Loss, Smoking
- What is being tested?
- Radiographic study
- How many people
- 44 participants
- Where
- 1 siteSpain
- Study dates
- 21 Feb 2022to 5 Jun 2022
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients provided with implant-supported restorative therapy selected from the Dentistry Hospital of the University of Barcelona database.
Who may be able to join
- Patients with a Smoking Habit
- Patients 20 - 80 years old
- Patients rehabilitated at DHUB
- Patients with a radiographic record at the time of implant loading
- Patients rehabilitated with one or more dental implants
Who cannot join
- Patients with untreated periodontal disease
- Patients with uncontrolled systemic pathology
- Pregnant women or in lactation
- Patients treated with antiresorptive drugs
- Patients without radiographic records
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Odontologico de Bellvitge
Barcelona, 08907
Lina Dumanova, +34633840676, linadumanova@mail.ru
About this study
Official title: Peri-implant Marginal Bone Loss and Implant Failure in Patients With Smoking Habit: a Case Control Study
The impact of smoking on dental implant failure has been a constant topic of discussion for the past decade and the current literature confronts the inconclusive evidence of tobacco for a marginal bone loss risk factor. The aim of the present investigation is to determine the association between tobacco and marginal bone loss or implant failure in a sample of patients who had received implant-supported restorative therapy in the Dentistry Hospital of the University of Barcelona (Campus of Bellvitge).
Considering that peri-implant marginal bone is essential for dental implant success, in this study we would like to establish the relationship between marginal bone loss around implants and smoking, in our own population study, in order to improve the prognosis of implant success in smoking patients.
On the other hand, knowing the negative effect tobacco has on marginal bone loss in dental implants, we will be able to better predict peri-implant bone loss and reveal the probability of implant failure in short and long-term in smokers. By informing the patient correctly, we can raise awareness and create an additional reason for them to stop smoking, or at least reduce the number of cigarettes they smoke per day.
Read the detailed description
The present study was designed as a retrospective case control study in a sample of patients with implant-supported restorative therapy conducted at the Dentistry Hospital of the University of Barcelona (Campus of Bellvitge). It is designed following the principles outlined in the Declaration of Helsinki (revised, amended, and clarified in 2013). All of the patients are being properly informed about the study according to the Comité Ético (CEIC) del Hospital Odontològic Universitat de Barcelona guidelines, and informed consent must be signed prior to the interventions. Patients provided with implant-supported restorative therapy were selected from the DHUB database. The sample is divided in two groups: smoking and non-smoking patients. An initial questionnaire is being conducted to obtain information regarding smoking habits. Candidates undergo an oral examination, radiographic study (Orthopantomography and Implant periapical radiograph) and implant probing to determine their peri-implant status.
- Conditions
- Dental Implant Failed, Marginal Bone Loss, Smoking
- Being tested
- Radiographic study
- Keywords
- Dental Implant
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiographic studyDiagnostic test
Candidates undergo a radiographic study (Orthopantomography and Implant periapical radiography)
| Study group | Role | What they receive |
|---|---|---|
| Smoking Patients with Dental Implantes | Smoking Patients rehabilitated with dental implants at the Dentistry Hospital of the University of Barcelona (Campus of Bellvitge). Receives: Diagnostic Test: Radiographic study | |
| Non-Smoking Patients with Dental Implantes | Non-Smoking Patients rehabilitated with dental implants at the Dentistry Hospital of the University of Barcelona (Campus of Bellvitge). Receives: Diagnostic Test: Radiographic study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal bone loss measured on Periapical Radiography
Marginal bone loss (MBL) around dental implants
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start21 Feb 2022
- Primary completion25 May 2022 (estimated)
- Study completion5 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lina Dumanova, University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05390242
- Sponsor's protocol ID
- UBMarginalBoneLossStudy
- Status last verified
- May 2022
- First submitted
- 12 May 2022
- Last updated
- 25 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kumar A, Nasreen S, Bandgar S, Bhowmick D, Vatsa R, Priyadarshni P. Comparative Evaluation of Marginal Bone Loss and Implant Failure Rate in Smokers and Nonsmokers. J Pharm Bioallied Sci. 2021 Jun;13(Suppl 1):S203-S206. doi: 10.4103/jpbs.JPBS_676_20. Epub 2021 Jun 5.
PubMed 34447076Naseri R, Yaghini J, Feizi A. Levels of smoking and dental implants failure: A systematic review and meta-analysis. J Clin Periodontol. 2020 Apr;47(4):518-528. doi: 10.1111/jcpe.13257. Epub 2020 Feb 7.
PubMed 31955453Linkevicius T, Linkevicius R, Gineviciute E, Alkimavicius J, Mazeikiene A, Linkeviciene L. The influence of new immediate tissue level abutment on crestal bone stability of subcrestally placed implants: A 1-year randomized controlled clinical trial. Clin Implant Dent Relat Res. 2021 Apr;23(2):259-269. doi: 10.1111/cid.12979. Epub 2021 Feb 2.
PubMed 33527729Nazeer J, Singh R, Suri P, Mouneshkumar CD, Bhardwaj S, Iqubal MA, Dinesh. Evaluation of marginal bone loss around dental implants in cigarette smokers and nonsmokers. A comparative study. J Family Med Prim Care. 2020 Feb 28;9(2):729-734. doi: 10.4103/jfmpc.jfmpc_1023_19. eCollection 2020 Feb.
PubMed 32318410Badenes-Catalan J, Pallares-Sabater A. Influence of Smoking on Dental Implant Osseointegration: A Radiofrequency Analysis of 194 Implants. J Oral Implantol. 2021 Apr 1;47(2):110-117. doi: 10.1563/aaid-joi-D-19-00223.
PubMed 32699886Raes S, Rocci A, Raes F, Cooper L, De Bruyn H, Cosyn J. A prospective cohort study on the impact of smoking on soft tissue alterations around single implants. Clin Oral Implants Res. 2015 Sep;26(9):1086-90. doi: 10.1111/clr.12405. Epub 2014 May 5.
PubMed 24798293Mumcu E, Beklen A. The effect of smoking on the marginal bone loss around implant-supported prostheses. Tob Induc Dis. 2019 May 20;17:43. doi: 10.18332/tid/109279. eCollection 2019.
PubMed 31516486Javed F, Rahman I, Romanos GE. Tobacco-product usage as a risk factor for dental implants. Periodontol 2000. 2019 Oct;81(1):48-56. doi: 10.1111/prd.12282.
PubMed 31407428Keenan JR, Veitz-Keenan A. The impact of smoking on failure rates, postoperative infection and marginal bone loss of dental implants. Evid Based Dent. 2016 Mar;17(1):4-5. doi: 10.1038/sj.ebd.6401144.
PubMed 27012564
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-implant Marginal Bone Loss and Implant Failure in Patients With Smoking Habit: a Case Control Study
- ClinicalTrials.gov ID
- NCT05390242
- Acronym / sponsor ID
- UBMarginalBoneLossStudy
- Conditions
- Dental Implant Failed, Marginal Bone Loss, Smoking
- Keywords
- Dental Implant
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- University of BarcelonaUniversity, hospital or other
- Study start
- 21 Feb 2022 (actual)
- Primary completion
- 25 May 2022 (estimated)
- Study completion
- 5 Jun 2022 (estimated)
- First posted
- 25 May 2022 (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 impact of smoking on dental implant failure has been a constant topic of discussion for the past decade and the current literature confronts the inconclusive evidence of tobacco for a marginal bone loss risk factor. The aim of the present investigation is to determine the association between tobacco and marginal bone loss or implant failure in a sample of patients who had received implant-supported restorative therapy in the Dentistry Hospital of the University of Barcelona (Campus of Bellvitge).
Considering that peri-implant marginal bone is essential for dental implant success, in this study we would like to establish the relationship between marginal bone loss around implants and smoking, in our own population study, in order to improve the prognosis of implant success in smoking patients.
On the other hand, knowing the negative effect tobacco has on marginal bone loss in dental implants, we will be able to better predict peri-implant bone loss and reveal the probability of implant failure in short and long-term in smokers. By informing the patient correctly, we can raise awareness and create an additional reason for them to stop smoking, or at least reduce the number of cigarettes they smoke per day.
Detailed description
The present study was designed as a retrospective case control study in a sample of patients with implant-supported restorative therapy conducted at the Dentistry Hospital of the University of Barcelona (Campus of Bellvitge). It is designed following the principles outlined in the Declaration of Helsinki (revised, amended, and clarified in 2013). All of the patients are being properly informed about the study according to the Comité Ético (CEIC) del Hospital Odontològic Universitat de Barcelona guidelines, and informed consent must be signed prior to the interventions. Patients provided with implant-supported restorative therapy were selected from the DHUB database. The sample is divided in two groups: smoking and non-smoking patients. An initial questionnaire is being conducted to obtain information regarding smoking habits. Candidates undergo an oral examination, radiographic study (Orthopantomography and Implant periapical radiograph) and implant probing to determine their peri-implant status.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smoking Patients with Dental Implantes | – | Diagnostic Test: Radiographic studySmoking Patients rehabilitated with dental implants at the Dentistry Hospital of the University of Barcelona (Campus of Bellvitge). |
| Non-Smoking Patients with Dental Implantes | – | Diagnostic Test: Radiographic studyNon-Smoking Patients rehabilitated with dental implants at the Dentistry Hospital of the University of Barcelona (Campus of Bellvitge). |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients provided with implant-supported restorative therapy selected from the Dentistry Hospital of the University of Barcelona database.
Key inclusion criteria (5 listed)
- Patients with a Smoking Habit
- Patients 20 - 80 years old
- Patients rehabilitated at DHUB
- Patients with a radiographic record at the time of implant loading
- Patients rehabilitated with one or more dental implants
Key exclusion criteria (5 listed)
- Patients with untreated periodontal disease
- Patients with uncontrolled systemic pathology
- Pregnant women or in lactation
- Patients treated with antiresorptive drugs
- Patients without radiographic records
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 |
|---|---|---|
| Radiographic studyCandidates undergo a radiographic study (Orthopantomography and Implant periapical radiography) | Diagnostic test | Non-Smoking Patients with Dental Implantes, Smoking Patients with Dental Implantes |
Primary outcome
Marginal bone loss measured on Periapical Radiography
Time frame: 60 minutes
Marginal bone loss (MBL) around dental implants
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- Background: PubMed 34447076Kumar A, Nasreen S, Bandgar S, Bhowmick D, Vatsa R, Priyadarshni P. Comparative Evaluation of Marginal Bone Loss and Implant Failure Rate in Smokers and Nonsmokers. J Pharm Bioallied Sci. 2021 Jun;13(Suppl 1):S203-S206. doi: 10.4103/jpbs.JPBS_676_20. Epub 2021 Jun 5.
- Background: PubMed 31955453Naseri R, Yaghini J, Feizi A. Levels of smoking and dental implants failure: A systematic review and meta-analysis. J Clin Periodontol. 2020 Apr;47(4):518-528. doi: 10.1111/jcpe.13257. Epub 2020 Feb 7.
- Background: PubMed 33527729Linkevicius T, Linkevicius R, Gineviciute E, Alkimavicius J, Mazeikiene A, Linkeviciene L. The influence of new immediate tissue level abutment on crestal bone stability of subcrestally placed implants: A 1-year randomized controlled clinical trial. Clin Implant Dent Relat Res. 2021 Apr;23(2):259-269. doi: 10.1111/cid.12979. Epub 2021 Feb 2.
- Background: PubMed 32318410Nazeer J, Singh R, Suri P, Mouneshkumar CD, Bhardwaj S, Iqubal MA, Dinesh. Evaluation of marginal bone loss around dental implants in cigarette smokers and nonsmokers. A comparative study. J Family Med Prim Care. 2020 Feb 28;9(2):729-734. doi: 10.4103/jfmpc.jfmpc_1023_19. eCollection 2020 Feb.
- Background: PubMed 32699886Badenes-Catalan J, Pallares-Sabater A. Influence of Smoking on Dental Implant Osseointegration: A Radiofrequency Analysis of 194 Implants. J Oral Implantol. 2021 Apr 1;47(2):110-117. doi: 10.1563/aaid-joi-D-19-00223.
- Background: PubMed 24798293Raes S, Rocci A, Raes F, Cooper L, De Bruyn H, Cosyn J. A prospective cohort study on the impact of smoking on soft tissue alterations around single implants. Clin Oral Implants Res. 2015 Sep;26(9):1086-90. doi: 10.1111/clr.12405. Epub 2014 May 5.
- Background: PubMed 31516486Mumcu E, Beklen A. The effect of smoking on the marginal bone loss around implant-supported prostheses. Tob Induc Dis. 2019 May 20;17:43. doi: 10.18332/tid/109279. eCollection 2019.
- Background: PubMed 31407428Javed F, Rahman I, Romanos GE. Tobacco-product usage as a risk factor for dental implants. Periodontol 2000. 2019 Oct;81(1):48-56. doi: 10.1111/prd.12282.
- Background: PubMed 27012564Keenan JR, Veitz-Keenan A. The impact of smoking on failure rates, postoperative infection and marginal bone loss of dental implants. Evid Based Dent. 2016 Mar;17(1):4-5. doi: 10.1038/sj.ebd.6401144.
- Individual participant dataSharing planned: Undecided
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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.
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 Marginal Bone Loss, run by University of Barcelona at 1 site in Spain.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 25 May 2022. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lina Dumanova (+34633840676, linadumanova@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Marginal bone loss measured on Periapical Radiography (time frame: 60 minutes). 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 NCT05390242, which also lists 9 linked publications.
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 25 May 2022.