Peri-implant Marginal Bone Loss and Implant Failure in Patients With Smoking Habit

Smoking Clinical Trial

Official title:

Peri-implant Marginal Bone Loss and Implant Failure in Patients With Smoking Habit: a Case Control Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05390242
• Other study ID #: UBMarginalBoneLossStudy
• Status: Recruiting
• Start date: February 21, 2022
• Est. completion date: June 5, 2022

Study information

• Verified date: May 2022
• Source: University of Barcelona
• Contact: Lina Dumanova
• Phone: +34633840676
• Email: linadumanova[@]mail.ru
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: June 5, 2022
• Est. primary completion date: May 25, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Patients with a Smoking Habit

2. Patients 20 - 80 years old

3. Patients rehabilitated at DHUB

4. Patients with a radiographic record at the time of implant loading

5. Patients rehabilitated with one or more dental implants

Exclusion Criteria:

1. Patients with untreated periodontal disease

2. Patients with uncontrolled systemic pathology

3. Pregnant women or in lactation

4. Patients treated with antiresorptive drugs

5. Patients without radiographic records

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Dental Implant Failed
• Marginal Bone Loss
• Smoking

Intervention

Diagnostic Test:
• Radiographic study
Candidates undergo a radiographic study (Orthopantomography and Implant periapical radiography)

Locations

Country	Name	City	State
Spain	Hospital Odontologico de Bellvitge	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
University of Barcelona

Country where clinical trial is conducted

Spain, 

References & Publications (9)

Badenes-Catalán J, Pallarés-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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Marginal bone loss measured on Periapical Radiography	Marginal bone loss (MBL) around dental implants	60 minutes