Clinical trial NCT05390242: Peri-implant Marginal Bone Loss and Implant Failure in Patients With Smoking Habit
Official title: Peri-implant Marginal Bone Loss and Implant Failure in Patients With Smoking Habit: a Case Control Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dental Implant Failed
Marginal Bone Loss
Smoking
Keywords: Dental Implant
Lead sponsor: University of Barcelona
Sponsor class: OTHER
First posted: 2022-05-25
Enrollment: 44
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients provided with implant-supported restorative therapy selected from the Dentistry Hospital of the University of Barcelona database.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Marginal bone loss measured on Periapical Radiography
timeFrame: 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Odontologico de Bellvitge
Study officials:
References:
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.
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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.