Association Between Smoking Habit and Peri-implant Diseases: a Case Control Study

NCT04952428 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 117

Last updated 2022-10-24

No results posted yet for this study

Summary

Although smoking has been proposed as well, as a risk factor/indicator for peri-implantitis, there is currently no conclusive evidence. The current literature confronts the inconclusive evidence of tobacco for a risk factor. Therefore, the aim of the present investigation is to determine the association between tobacco and peri-implantitis in sample of patients who had received therapy implant-supported restorative therapy in a university setting.

The present study was designed as a retrospective case control study in a sample of patients with implant-supported restorative therapy 7-19 years after restorative phase. The study was conducted at the Clinica Universitaria d'Odontologia (CUO) in the Universitat Internacional de Catalunya (UIC) for 1 month and was performed following the principles outlined in the Declaration of Helsinki (revised, amended, and clarified in 2013. Prior to enrol the study a written informed consent was signed. Patients provided with implant-supported restorative therapy between 2001-2013 was selected from the UIC database. The sample was divided in three groups: healthy patients, patients with mucositis and patients with peri-implantitis. During the examination, the clinician reviewed with the patient the Information and Medication History Forms and record the anthropometric, socio-demographic and clinical information. An initial questionnaire was conducted to obtain information regarding age, gender, medical history, medication, and health behaviour. Candidates underwent an oral pathology examination and a full-mouth probing using a standardize pressure (20N) probe SONDA PA\_ON (Orange Dental®, Aspachstr, Biberach, Germany) to determine their periodontal and peri-implant status. All statistical analyses were performed with the package RStudio (V2.5). Descriptive characteristics regarding all the covariates were summarized. Periimplant bone loss (95% Confidence Interval - 95% CI) were calculated both at implant- and at patient-level. A multilevel regression model will be applied to evaluate the influence of some risk/protective indicators on the risk for peri-implant bone loss. Risk/protective indicators for periimplantitis will be studied using multilevel (mixed-effects) multivariate regression analyses (patient- and implant-level). Each potential indicator was tested individually by adding it to an empty model having as dependent variable the peri-implant status and testing the significance.

Conditions

  • Peri-Implantitis
  • Peri-implant Mucositis
  • Bone Loss, Alveolar

Interventions

BEHAVIORAL

Re-examination visit ("today visit")

Re-examination visit ("today visit") A guidebook will be prepared to standardize procedures throughout the protocol, step by step, for all questionnaires and evidence collection. The data will be transferred to a computerized database. The clinician will review with the patient the Information and Medication History Forms and record the anthropometric, socio-demographic and clinical information. Candidates will undergo an oral pathology examination and a full-mouth manual probing using a periodontal probe SONDA PA\_ON (Orange Dental®, Aspachstr, Biberach, Germany) to determine their periodontal and peri-implant status. Clinical and radiographic examination will be performed. Moreover, signs as presence of suppuration, bleeding, redness, probing depth must be recorded at 6 sites per implant applying. As well, a specific survey about tobacco habits including modification of Fagestrom \& Richmond test will be conducted.

Sponsors & Collaborators

  • Universitat Internacional de Catalunya

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-15
Primary Completion
2021-02-22
Completion
2021-06-30

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04952428 on ClinicalTrials.gov