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

NCT ID: NCT05390242

Last Updated: 2022-05-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 44 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-21
• Study Completion Date: 2022-06-05

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.

Conditions

Dental Implant Failed; Marginal Bone Loss; Smoking

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Smoking Patients with Dental Implantes

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

Radiographic study

Intervention Type: DIAGNOSTIC_TEST

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).

Radiographic study

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Radiographic study

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

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Barcelona

OTHER

Sponsor Role: lead

Responsible Party

Lina Dumanova

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Odontologico de Bellvitge

Barcelona, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Lina Dumanova

Role: CONTACT

linadumanova@mail.ru

+34633840676

Facility Contacts

Lina Dumanova

Role: primary

linadumanova@mail.ru

+34633840676

References

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Reference Type: BACKGROUND

PMID: 34447076 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 31516486 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 31407428 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27012564 (View on PubMed)

Other Identifiers

UBMarginalBoneLossStudy

Identifier Type: -

Identifier Source: org_study_id