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

• Conditions: Smoking; Marginal Bone Loss; Dental Implant Failed
• Interventions: Diagnostic Test: Radiographic study

• Registration Number: NCT05390242
• Lead Sponsor: University of Barcelona

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.

Study Timeline

• Study Start: 2022-02-21
• Status Verified: 2022-05
• Study First Submitted: 2022-05-12
• Study First Submitted QC: 2022-05-21
• Last Update Submitted: 2022-05-21
• Primary Completion: 2022-05-25
• Study First Posted: 2022-05-25
• Last Update Posted: 2022-05-25
• Study Completion: 2022-06-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-Smoking Patients with Dental Implantes	Radiographic study	Non-Smoking Patients rehabilitated with dental implants at the Dentistry Hospital of the University of Barcelona (Campus of Bellvitge).
Smoking Patients with Dental Implantes	Radiographic study	Smoking Patients rehabilitated with dental implants at the Dentistry Hospital of the University of Barcelona (Campus of Bellvitge).

Primary Outcome Measures

Name	Time	Method
Marginal bone loss measured on Periapical Radiography	60 minutes	Marginal bone loss (MBL) around dental implants

Trial Locations

Locations (1)

Hospital Odontologico de Bellvitge; 🇪🇸 Barcelona, Spain