NCT05390242

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 21, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 25, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2022

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2022

Completed
Last Updated

May 25, 2022

Status Verified

May 1, 2022

Enrollment Period

3 months

First QC Date

May 12, 2022

Last Update Submit

May 21, 2022

Conditions

Keywords

Dental Implant

Outcome Measures

Primary Outcomes (1)

  • Marginal bone loss measured on Periapical Radiography

    Marginal bone loss (MBL) around dental implants

    60 minutes

Study Arms (2)

Smoking Patients with Dental Implantes

Smoking Patients rehabilitated with dental implants at the Dentistry Hospital of the University of Barcelona (Campus of Bellvitge).

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).

Diagnostic Test: Radiographic study

Interventions

Radiographic studyDIAGNOSTIC_TEST

Candidates undergo a radiographic study (Orthopantomography and Implant periapical radiography)

Non-Smoking Patients with Dental ImplantesSmoking Patients with Dental Implantes

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients provided with implant-supported restorative therapy selected from the Dentistry Hospital of the University of Barcelona database.

You may qualify if:

  • 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

You may not qualify if:

  • Patients with untreated periodontal disease
  • Patients with uncontrolled systemic pathology
  • Pregnant women or in lactation
  • Patients treated with antiresorptive drugs
  • Patients without radiographic records

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Odontologico de Bellvitge

Barcelona, 08907, Spain

RECRUITING

Related Publications (9)

  • 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.

    PMID: 34447076BACKGROUND
  • Naseri 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.

    PMID: 31955453BACKGROUND
  • Linkevicius 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.

    PMID: 33527729BACKGROUND
  • Nazeer 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.

    PMID: 32318410BACKGROUND
  • Badenes-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.

    PMID: 32699886BACKGROUND
  • Raes 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.

    PMID: 24798293BACKGROUND
  • Mumcu 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.

    PMID: 31516486BACKGROUND
  • Javed 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.

    PMID: 31407428BACKGROUND
  • Keenan 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.

    PMID: 27012564BACKGROUND

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 12, 2022

First Posted

May 25, 2022

Study Start

February 21, 2022

Primary Completion

May 25, 2022

Study Completion

June 5, 2022

Last Updated

May 25, 2022

Record last verified: 2022-05

Locations