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

May 21, 2022 updated by: Lina Dumanova, University of Barcelona

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

44

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Barcelona, Spain, 08907
        • Recruiting
        • Hospital Odontologico de Bellvitge
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Candidates undergo a radiographic study (Orthopantomography and Implant periapical radiography)
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
Candidates undergo a radiographic study (Orthopantomography and Implant periapical radiography)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Marginal bone loss measured on Periapical Radiography
Time Frame: 60 minutes
Marginal bone loss (MBL) around dental implants
60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2022

Primary Completion (Anticipated)

May 25, 2022

Study Completion (Anticipated)

June 5, 2022

Study Registration Dates

First Submitted

May 12, 2022

First Submitted That Met QC Criteria

May 21, 2022

First Posted (Actual)

May 25, 2022

Study Record Updates

Last Update Posted (Actual)

May 25, 2022

Last Update Submitted That Met QC Criteria

May 21, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UBMarginalBoneLossStudy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Smoking

Clinical Trials on Radiographic study

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Montenegro

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe